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prevention of head louse infestation: a randomised, double-blind, cross-over study of a novel concept product, 1% 1,2-octanediol spray versus placebo
by：ER Bottle
2020-01-18
Determine if spray containing 1,2-is used frequently
Xin alcohol 1%, which has been shown to inhibit the survival of head lice, can prevent new infections.
Random settings, doubleblind, cross-
Community research in cam county, UK is over.
Sixty-three male and female school children aged 4-16 were identified as having a high risk of repeated infection.
Only the youngest members of the family attended school.
The intervention participants were treated with the elimination of lice and were randomly spaced for 6 weeks at a time interval of 1% ethanol or placebo spray and then crossed-
Sprayed on other sprays for 6 weeks.
If the hair is washed, parents spray it at least twice a week or more frequently.
Investigators monitor the presence of pests on a weekly basis and supplement the spray supply.
Primary and secondary outcome measures the primary endpoint is the time spent before the first infection event occurs.
The second measure is the safety of the product in normal use.
Intention of result-to-
Treat analysis found a total of 32 confirmed infections in 20 participants, of which 9 were infected when using both products.
Of the nine participants, the time of the first infection showed a significant advantage of 1% bitterness (p=0. 0129). Per-
The protocol analysis shows only trends, as the population included is not sufficient to prove the importance.
There are no serious adverse events, there are only two possible adverse events related to treatment, one is short red spot and the other is a rash that has subsided after 5 days.
Conclusion the conventional use of 1% alcohol spray can effectively prevent the occurrence of pests.
The conclusion is that this product is effective if applied regularly and thoroughly.
Registration number isrctn095 24995
Objective to determine whether spray containing 1,2-is frequently used
Xin alcohol 1%, which has been shown to inhibit the survival of head lice, can prevent new infections.
Random settings, doubleblind, cross-
Community research in cam county, UK is over.
Sixty-three male and female school children aged 4-16 were identified as having a high risk of repeated infection.
Only the youngest members of the family attended school.
The intervention participants were treated with the elimination of lice and were randomly spaced for 6 weeks at a time interval of 1% ethanol or placebo spray and then crossed-
Sprayed on other sprays for 6 weeks.
If the hair is washed, parents spray it at least twice a week or more frequently.
Investigators monitor the presence of pests on a weekly basis and supplement the spray supply.
Primary and secondary outcome measures the primary endpoint is the time spent before the first infection event occurs.
The second measure is the safety of the product in normal use.
Intention of result-to-
Treat analysis found a total of 32 confirmed infections in 20 participants, of which 9 were infected when using both products.
Of the nine participants, the time of the first infection showed a significant advantage of 1% bitterness (p=0. 0129). Per-
The protocol analysis shows only trends, as the population included is not sufficient to prove the importance.
There are no serious adverse events, there are only two possible adverse events related to treatment, one is short red spot and the other is a rash that has subsided after 5 days.
Conclusion the conventional use of 1% alcohol spray can effectively prevent the occurrence of pests.
The conclusion is that this product is effective if applied regularly and thoroughly.
Registration number isrctn095 24995
Despite the recent development of therapeutic products that are not affected by pesticide resistance, head lice infections are still prevalent.
There are many treatment options in European countries, however, some children are repeatedly infected despite being effective for most users.
Sometimes this is because the caregiver is unsuccessful in using the treatment, but children who have recently been treated will soon be infected again.
When discussing with the parents concerned, most of them, in addition to effective treatment, want to have a product that protects the child from infection.
Some people interpret this as the use of insect repellent.
However, in essence, insect repellent is volatile and therefore does not last long for hair, which means that they have a limited life span, especially if the application is not thorough.
2 also, as the lice crawl from head to head instead of looking for a host, the chemicals intended to disrupt the host-
Looking for function in flying insects may not have any activity on crawling lice.
In any case, it is recognized that the effectiveness of mosquito repellent is limited, so users may be bitten occasionally.
If similar failures occur on lice, the infection may be established without being noticed.
In the past, it was mistakenly believed that pesticides with residual effects could prevent re-infection in a few weeks.
This may be effective for some, but the effects of the residue are inconsistent and systematically filtered out by shampooing, so that the level of the pesticide is fast for any lice transferred to the hair
3-6 inevitably, at the beginning of 1990, lice exposed to low-level pesticides were selected to develop resistance to the proposed pesticides and malion pesticides.
7 Another prevention strategy is to use a product on a regular basis to prevent lice from contracting rather than repelling them.
This has never been true for traditional pesticides, and while anecdotal evidence suggests it may have been widely used, it is acceptable to use low-dose cosmetics on a regular basis, the physical action chemicals that destroy the skin lipids of the lice should kill the insects in contact with the treated hair and limit the risk of infection.
We know 1, 2-
Xin alcohol 5% is effective in eliminating identified head lice infections.
We also observed in the 1, 2-pre-clinical study
1% solutions are able to kill lice and, although slower, also suppress spawning.
This report describes a random, doubleblind, cross-
At the end, clinical study of spray containing 1% 1,2-
Compared to placebo, the bitterness developed as a preventive measure of this type.
Materials and methods sparticipantswe recruits participants in a manner similar to local radio advertising and writing to families who have participated in previous clinical trials and expressed their desire to participate in further studies.
A manual of information was sent to potential participants and if they wish to attend after reading, they will make an appointment to start the study on a suitable date.
Unlike other studies, only the youngest members of the school-going family were recruited for the study.
Therefore, the minimum age is 4 years and the maximum age is 16 years.
Other family members are not included, so they can be a potential source of infection for participants.
Each person who joins is done through a standardized consent/consent procedure, and then the presence of head lice is evaluated using a plastic head lice detection comb (
KSL Consulting, Denmark.
This is primarily intended to provide information about the person\'s current risk profile as everyone is treated to ensure that all participants are starting to be protected from infection.
Other family members who were infected at the time were treated to reduce the risk that index members would face immediate re-infection pressure.
All participants provided baseline data on age, gender and hair traits, as well as information on current medications and medical history.
All treatments and assessments were performed at the participant\'s home.
Participation fees are not paid.
As noted above, the age of eligibility and inclusion criteria is appropriate;
There is a risk of re-infection, based on previous individuals and family history, and is willing to participate in an estimated 14-week study.
Exclusion criteria are a history of allergies or sensitivity to test products or placebo ingredients; of long-
Diseases of the scalp, such as impeachment or psoriasis;
Pregnancy or breastfeeding within 1 month of entry and participation in other clinical studies.
The clinical trials of EthicsA have also been notified to the UK\'s drug and health care product regulatory authorities, referring to CI/2012/0032.
Parents provide written consent for participating children.
Written consent was also provided by the participants.
The general practitioner of each participant was informed that they had participated in the event.
The study was conducted in accordance with the principles of the Helsinki Declaration and the International Coordination Conference (ICH)
Guidelines for good clinical practice and European standards (GCP).
This is a random, double. blind, cross-
Over-study of 1% 1,2-
The bitterness in the hair-
Conditioning base (
The protection and development of Thornton rose Co. , Ltd. .
Trigger spray high density polyethylene with 100 (HDPE)
Plastic bottles like fake
In The detangler conditioning spray, used twice a week for washing and towelsdried hair.
6-more frequent applications are allowed during the period
For example, use a week if participants wash their hair more often.
The placebo-controlled subjects were ostensibly identical and applied in the same manner and at the same speed.
Both methods need to shake before application and warn not to spray on the face to prevent eye irritation.
At the time of registration and cross-registration
Between the use of different therapeutic sprays, we provided treatment to all participants to eliminate any lice that already exist, even if no lice were found.
For this we used dimeticone 4% liquid gel (
Liquid gel used to be in Thornton and roslín, UK)
Apply for 15 minutes before washing and repeat treatment after 7 days, which is not absolutely necessary due to the high level of efficacy of the product, 9 but the second application is the requirement of the Drug and Health Products Regulatory Authority to approve the study (MHRA)assessor.
We use the same product to treat infections acquired by participants and family members during the study.
Participants who were found to be infected at any time were not withdrawn.
The investigators were treated.
During the use of dimeticone liquid gel, the infected participants continued to use the spray they specified as this therapeutic product was
Residue, so there is no protective effect between treatment.
At the beginning of the study, a manual was provided to parents/carers (s)
For the use of spray.
Once a week, an investigator visits each family, uses a test comb to check if the participant has lice, provides a new bottle of spray, and returns the used bottle to the research center for weighing, to determine the number of uses.
Definition of infection we expect to find some lice when using preventive spray, as participants may have found lice at school in the afternoon before the visit.
So unless there are five or more big lice (
Adult and Stage 3 nymphs)
Or if there\'s a fairy (
Phase I and Phase II nymphs)present.
Both evidence suggests that it has been a while.
Only when eggs are laid Will Young nymphs appear, and most of the re-infection events begin from less than five adult or third stage nymphs.
If any stage of lice is found during two consecutive visits, this is considered to be the primary evidence of persistent infection.
When the infection is confirmed, with the exception of dimeticone 4% liquid gel, the application is used twice a week for treatment, and any lice found are fixed in the case record with transparent tape as confirmation.
At the end of the next 12 weeks --
The assessors noted whether there were live lice.
Lice were found in previous evaluations but no action was taken.
There are more than five lice.
There are nymphs in the first or second stages.
If the assessor finds a live tick (‘1’)
If either of the \"2\", \"3\" or \"4\" is applied at the same time, this is considered an active infection.
Collect and secure the lice in the case book and treat the participants to eliminate the infection.
After laboratory tests, the number of lice and the total number of lice at each developmental stage were recorded.
The purpose of the study was to demonstrate that, in the case of frequent use, 1% Xin alcohol spray can prevent head lice infection by killing any lice crawling on treated hair.
Unlike insect repellent, we recognize that lice will not be suppressed to climb on the head, but if applied correctly, the product should be suppressed, effectively limiting the risk of human infection using it.
The main outcome measurement is the time of the first infection, identified by systematic detection of the entire head.
The secondary end point is whether an infection occurs at any time when using the product, and the safety of the spray in use.
The aim of this study was to detect the superiority of 1% bitterness products compared with placebo.
This study is an unusual type for clinical studies because, unlike most clinical studies, participants in this study do not yet have a therapeutic disease.
The purpose of preventing preventable diseases is also different from other \"preventive\" studies, such as vaccine trials, since these studies are often long-term
The long-term population study attracted a large number of participants, who overall had a small detectable probability of failure.
We put forward a cross
Because it allows less participants to participate in the design, it also allows each participant to act as his/her own control.
Development Design is difficult, because the risk factors of each person are unknown, so only random may not completely solve the difference in infection risk caused by social and family environment, especially in a relatively small study queue.
Therefore, since
Controlling everyone is an attractive option to avoid any deviation caused by these unknown factors.
Preliminary analysis based on timeto-
The beginning of the first infection was considered a more effective way to detect the difference between 1% bitterness and placebo than a simpler method based on whether the participants were infected.
Sample size calculation of statistical consultants (
See online supplementary documents)
10 K simulation based on crossover
In studies using a range of defined study sizes, the power to detect significant differences in 95% CI was set, and then the minimum sample size was estimated to obtain a power of 80% or 90%.
For the risk of infection, we examined the participants\' experience in previous studies of re-infection three to five times a year, estimated to be equivalent to a rate of approximately 6-10% per person per week.
Therefore, when using active spray, we expect the risk to be reduced by 60% to 70%.
Therefore, we selected the sample size of 68 participants based on the hypothetical placebo weekly infection rate of 6%, and 2%, based on the estimated sample size of 64 times 80% times plus the drop-out allowance.
The weekly survival rate of these comparable to placebo was 94%, and the survival rate of Xin alcohol was 98%, or 6-
The weekly survival rate was 69% and 88, respectively. 6%.
This sample size gives 19 expectations.
Possible effects of placebo and 7.
In the course of the study, No. 8 was used for bitterness.
Random allocation: allocation hidden random treatment allocation code is generated using a free online random service with seed number 26 u2005 438 created in October 10, 2012.
Treatment is allocated in 8 balance blocks of 10 treatments, and if replacement is required, a spare block is randomly assigned.
Handles the anonymous identification of the distribution containing the product to be used and the application instructions.
The product identification/instruction manual is sealed in an opaque sequential numbered envelope with participant numbers taken from a random schedule.
The study is at a cross
Each participant was over-designed as their own control, so all participants used both preparations during the study.
Product Code is not broken until data collection is completed, data entry into research database and database locking.
Statistical analysis of differences between test treatments
In design and based on internal
Differences between the efficacy of 1% bitterness and placebo in the respective 6-process participants
Treatment period of the week
PN Lee Statistics and Computing Co. , Ltd. conducted major data management and analysis in collaboration with investigators.
Analyze binary data using McNemar test and use the Wilcoxon symbol-
Mapping test for paired data.
We performed an overall and separate analysis of participants in each random Group, based on the treatment they received first.
For the time when the infection was first confirmed, we used 7-
Ranking of points scored by participants: 1 = first confirmed infection
Up assment2 = the first time it happens when it happens the second time --up assessment. . . .
6 = the first time occurred at the time of the sixth
Up assessment 7 = no confirmation of infection was made in six assessment endpoint analyses, including whether the infection occurred at any time, every 6-
Number and type of treatment cycles and adverse events.
For the main results, we used Kaplan-
Mel curve to illustrate the time pattern in which participants survived from infection when 1% bitter or placebo was used.
We did not use log-to test the difference between notability treatments
Because these two curves are not
Based on the independence of the same participants.
We analyzed the intention. to-treat (ITT)and per-protocol (PP)groups.
Before we start, we expect to have some people who drop out of school, mainly in the second 6-
Treatment time of week
To address this problem, if this is the case, we plan to conduct an analysis, assuming that this is caused by infection, allowing for dropping out of school.
So, in order to analyze the drop-out situation, we assume that an infection occurred in the following first week
This is impossible.
If this occurs during the first treatment period, then there is no data for the second treatment period, and we assume that in two 6-week periods.
However, based on previous experience in this community, we also expect that if a drop-out occurs, it will occur at a very low rate, there is no need to review or other specific measures to address the issues in the analysis.
We also analyzed baseline features to compare participants to products that were randomly first accepted.
Accurate testing of binary data using Fisher and Mann-
Whitney U test for counting and ranking variables.
Participants we recruited participants in a manner similar to the previous survey of local radio advertising and wrote to families who participated in previous clinical trials and expressed their desire to participate in further studies.
A manual of information was sent to potential participants and if they wish to attend after reading, they will make an appointment to start the study on a suitable date.
Unlike other studies, only the youngest members of the school-going family were recruited for the study.
Therefore, the minimum age is 4 years and the maximum age is 16 years.
Other family members are not included, so they can be a potential source of infection for participants.
Each person who joins is done through a standardized consent/consent procedure, and then the presence of head lice is evaluated using a plastic head lice detection comb (
KSL Consulting, Denmark.
This is primarily intended to provide information about the person\'s current risk profile as everyone is treated to ensure that all participants are starting to be protected from infection.
Other family members who were infected at the time were treated to reduce the risk that index members would face immediate re-infection pressure.
All participants provided baseline data on age, gender and hair traits, as well as information on current medications and medical history.
All treatments and assessments were performed at the participant\'s home.
Participation fees are not paid.
As noted above, the age of eligibility and inclusion criteria is appropriate;
There is a risk of re-infection, based on previous individuals and family history, and is willing to participate in an estimated 14-week study.
Exclusion criteria are a history of allergies or sensitivity to test products or placebo ingredients; of long-
Diseases of the scalp, such as impeachment or psoriasis;
Pregnancy or breastfeeding within 1 month of entry and participation in other clinical studies.
The clinical trials of EthicsA have also been notified to the UK\'s drug and health care product regulatory authorities, referring to CI/2012/0032.
Parents provide written consent for participating children.
Written consent was also provided by the participants.
The general practitioner of each participant was informed that they had participated in the event.
The study was conducted in accordance with the principles of the Helsinki Declaration and the International Coordination Conference (ICH)
Guidelines for good clinical practice and European standards (GCP).
This is a random, double. blind, cross-
Over-study of 1% 1,2-
The bitterness in the hair-
Conditioning base (
The protection and development of Thornton rose Co. , Ltd. .
Trigger spray high density polyethylene with 100 (HDPE)
Plastic bottles like fake
In The detangler conditioning spray, used twice a week for washing and towelsdried hair.
6-more frequent applications are allowed during the period
For example, use a week if participants wash their hair more often.
The placebo-controlled subjects were ostensibly identical and applied in the same manner and at the same speed.
Both methods need to shake before application and warn not to spray on the face to prevent eye irritation.
At the time of registration and cross-registration
Between the use of different therapeutic sprays, we provided treatment to all participants to eliminate any lice that already exist, even if no lice were found.
For this we used dimeticone 4% liquid gel (
Liquid gel used to be in Thornton and roslín, UK)
Apply for 15 minutes before washing and repeat treatment after 7 days, which is not absolutely necessary due to the high level of efficacy of the product, 9 but the second application is the requirement of the Drug and Health Products Regulatory Authority to approve the study (MHRA)assessor.
We use the same product to treat infections acquired by participants and family members during the study.
Participants who were found to be infected at any time were not withdrawn.
The investigators were treated.
During the use of dimeticone liquid gel, the infected participants continued to use the spray they specified as this therapeutic product was
Residue, so there is no protective effect between treatment.
At the beginning of the study, a manual was provided to parents/carers (s)
For the use of spray.
Once a week, an investigator visits each family, uses a test comb to check if the participant has lice, provides a new bottle of spray, and returns the used bottle to the research center for weighing, to determine the number of uses.
Definition of infection we expect to find some lice when using preventive spray, as participants may have found lice at school in the afternoon before the visit.
So unless there are five or more big lice (
Adult and Stage 3 nymphs)
Or if there\'s a fairy (
Phase I and Phase II nymphs)present.
Both evidence suggests that it has been a while.
Only when eggs are laid Will Young nymphs appear, and most of the re-infection events begin from less than five adult or third stage nymphs.
If any stage of lice is found during two consecutive visits, this is considered to be the primary evidence of persistent infection.
When the infection is confirmed, with the exception of dimeticone 4% liquid gel, the application is used twice a week for treatment, and any lice found are fixed in the case record with transparent tape as confirmation.
At the end of the next 12 weeks --
The assessors noted whether there were live lice.
Lice were found in previous evaluations but no action was taken.
There are more than five lice.
There are nymphs in the first or second stages.
If the assessor finds a live tick (‘1’)
If either of the \"2\", \"3\" or \"4\" is applied at the same time, this is considered an active infection.
Collect and secure the lice in the case book and treat the participants to eliminate the infection.
After laboratory tests, the number of lice and the total number of lice at each developmental stage were recorded.
The purpose of the study was to demonstrate that, in the case of frequent use, 1% Xin alcohol spray can prevent head lice infection by killing any lice crawling on treated hair.
Unlike insect repellent, we recognize that lice will not be suppressed to climb on the head, but if applied correctly, the product should be suppressed, effectively limiting the risk of human infection using it.
The main outcome measurement is the time of the first infection, identified by systematic detection of the entire head.
The secondary end point is whether an infection occurs at any time when using the product, and the safety of the spray in use.
The aim of this study was to detect the superiority of 1% bitterness products compared with placebo.
This study is an unusual type for clinical studies because, unlike most clinical studies, participants in this study do not yet have a therapeutic disease.
The purpose of preventing preventable diseases is also different from other \"preventive\" studies, such as vaccine trials, since these studies are often long-term
The long-term population study attracted a large number of participants, who overall had a small detectable probability of failure.
We put forward a cross
Because it allows less participants to participate in the design, it also allows each participant to act as his/her own control.
Development Design is difficult, because the risk factors of each person are unknown, so only random may not completely solve the difference in infection risk caused by social and family environment, especially in a relatively small study queue.
Therefore, since
Controlling everyone is an attractive option to avoid any deviation caused by these unknown factors.
Preliminary analysis based on timeto-
The beginning of the first infection was considered a more effective way to detect the difference between 1% bitterness and placebo than a simpler method based on whether the participants were infected.
Sample size calculation of statistical consultants (
See online supplementary documents)
10 K simulation based on crossover
In studies using a range of defined study sizes, the power to detect significant differences in 95% CI was set, and then the minimum sample size was estimated to obtain a power of 80% or 90%.
For the risk of infection, we examined the participants\' experience in previous studies of re-infection three to five times a year, estimated to be equivalent to a rate of approximately 6-10% per person per week.
Therefore, when using active spray, we expect the risk to be reduced by 60% to 70%.
Therefore, we selected the sample size of 68 participants based on the hypothetical placebo weekly infection rate of 6%, and 2%, based on the estimated sample size of 64 times 80% times plus the drop-out allowance.
The weekly survival rate of these comparable to placebo was 94%, and the survival rate of Xin alcohol was 98%, or 6-
The weekly survival rate was 69% and 88, respectively. 6%.
This sample size gives 19 expectations.
Possible effects of placebo and 7.
In the course of the study, No. 8 was used for bitterness.
Random allocation: allocation hidden random treatment allocation code is generated using a free online random service with seed number 26 u2005 438 created in October 10, 2012.
Treatment is allocated in 8 balance blocks of 10 treatments, and if replacement is required, a spare block is randomly assigned.
Handles the anonymous identification of the distribution containing the product to be used and the application instructions.
The product identification/instruction manual is sealed in an opaque sequential numbered envelope with participant numbers taken from a random schedule.
The study is at a cross
Each participant was over-designed as their own control, so all participants used both preparations during the study.
Product Code is not broken until data collection is completed, data entry into research database and database locking.
Statistical analysis of differences between test treatments
In design and based on internal
Differences between the efficacy of 1% bitterness and placebo in the respective 6-process participants
Treatment period of the week
PN Lee Statistics and Computing Co. , Ltd. conducted major data management and analysis in collaboration with investigators.
Analyze binary data using McNemar test and use the Wilcoxon symbol-
Mapping test for paired data.
We performed an overall and separate analysis of participants in each random Group, based on the treatment they received first.
For the time when the infection was first confirmed, we used 7-
Ranking of points scored by participants: 1 = first confirmed infection
Up assment2 = the first time it happens when it happens the second time --up assessment. . . .
6 = the first time occurred at the time of the sixth
Up assessment 7 = no confirmation of infection was made in six assessment endpoint analyses, including whether the infection occurred at any time, every 6-
Number and type of treatment cycles and adverse events.
For the main results, we used Kaplan-
Mel curve to illustrate the time pattern in which participants survived from infection when 1% bitter or placebo was used.
We did not use log-to test the difference between notability treatments
Because these two curves are not
Based on the independence of the same participants.
We analyzed the intention. to-treat (ITT)and per-protocol (PP)groups.
Before we start, we expect to have some people who drop out of school, mainly in the second 6-
Treatment time of week
To address this problem, if this is the case, we plan to conduct an analysis, assuming that this is caused by infection, allowing for dropping out of school.
So, in order to analyze the drop-out situation, we assume that an infection occurred in the following first week
This is impossible.
If this occurs during the first treatment period, then there is no data for the second treatment period, and we assume that in two 6-week periods.
However, based on previous experience in this community, we also expect that if a drop-out occurs, it will occur at a very low rate, there is no need to review or other specific measures to address the issues in the analysis.
We also analyzed baseline features to compare participants to products that were randomly first accepted.
Accurate testing of binary data using Fisher and Mann-
Whitney U test for counting and ranking variables.
We recruited 64 potential participants but one of them lost track-
It is OK after one pretreatment using dimeticone 4% liquid gel.
Since this person has not yet entered the stage of investigation treatment, we believe that they have not actually started to participate and should be removed from the analysis, leaving 63 registered participants in the ITT population, 34 times given to Sinol, it was followed by placebo, placebo was given 29 times, followed by Xinyi.
All participants were recruited from the surrounding area of Cambridge, England.
Most were recruited between October 22-20 and November 16.
All participants completed the two arms of the study halfwayMarch 2013.
Of those recruited, two participants did not complete the study, one withdrew and one lost trackup.
20 participants were so inconsistent in product use that we excluded them from the PP population for agreement bias.
The reasons for the exclusion can be divided into five types summarized in Figure 1: 6 participants accidentally used 7 bottles of the first study treatment and 5 bottles of the second study treatment, instead of six bottles per group;
The two received rescue treatment at the wrong time;
A lost track.
One fell out.
Two people were unable to assess three times in the agreed time window.
Some of them were also found to be in a group that did not apply products on a regular basis.
A total of 16 participants failed to apply the treatment correctly within the agreed protocol.
14 of them (
6 when using alcohol and 8 when using placebo)
Failed to use any spray for one or more weeks.
If the spray is applied only once in a given week, it is considered a slight protocol deviation when it should be applied at least twice.
However, repeated inconsistency in use is considered to be a major deviation and, therefore, for the analysis, the two were excluded from the PP population, because they only use spray once a week on three or more occasions.
Through the study, download the flow chart of participants in the new tabDownload powerpoint figure 1.
These participants were included in the ITT analysis but were excluded from the PP analysis.
Baseline data for 63 participants in the survey phase, 50 (79. 4%)
Girls and 18 years old (28. 6%)
The age is 10 years old or over, and the rest are 4-9 years old.
There was no significant difference in age and gender in the randomized grouping, and there was no significant difference in the size of the family, the number of members who had examined the lice in the family, or the number of people who had found the lice at baseline (table 1).
Of the family members who were diagnosed with lice but did not participate in the study, only one refused treatment to eliminate the lice.
Again, there is no difference between the random grouping in terms of hair length, curl degree or hair type.
However, there is an important (p
Xin alcohol 1%, which has been shown to inhibit the survival of head lice, can prevent new infections.
Random settings, doubleblind, cross-
Community research in cam county, UK is over.
Sixty-three male and female school children aged 4-16 were identified as having a high risk of repeated infection.
Only the youngest members of the family attended school.
The intervention participants were treated with the elimination of lice and were randomly spaced for 6 weeks at a time interval of 1% ethanol or placebo spray and then crossed-
Sprayed on other sprays for 6 weeks.
If the hair is washed, parents spray it at least twice a week or more frequently.
Investigators monitor the presence of pests on a weekly basis and supplement the spray supply.
Primary and secondary outcome measures the primary endpoint is the time spent before the first infection event occurs.
The second measure is the safety of the product in normal use.
Intention of result-to-
Treat analysis found a total of 32 confirmed infections in 20 participants, of which 9 were infected when using both products.
Of the nine participants, the time of the first infection showed a significant advantage of 1% bitterness (p=0. 0129). Per-
The protocol analysis shows only trends, as the population included is not sufficient to prove the importance.
There are no serious adverse events, there are only two possible adverse events related to treatment, one is short red spot and the other is a rash that has subsided after 5 days.
Conclusion the conventional use of 1% alcohol spray can effectively prevent the occurrence of pests.
The conclusion is that this product is effective if applied regularly and thoroughly.
Registration number isrctn095 24995
Objective to determine whether spray containing 1,2-is frequently used
Xin alcohol 1%, which has been shown to inhibit the survival of head lice, can prevent new infections.
Random settings, doubleblind, cross-
Community research in cam county, UK is over.
Sixty-three male and female school children aged 4-16 were identified as having a high risk of repeated infection.
Only the youngest members of the family attended school.
The intervention participants were treated with the elimination of lice and were randomly spaced for 6 weeks at a time interval of 1% ethanol or placebo spray and then crossed-
Sprayed on other sprays for 6 weeks.
If the hair is washed, parents spray it at least twice a week or more frequently.
Investigators monitor the presence of pests on a weekly basis and supplement the spray supply.
Primary and secondary outcome measures the primary endpoint is the time spent before the first infection event occurs.
The second measure is the safety of the product in normal use.
Intention of result-to-
Treat analysis found a total of 32 confirmed infections in 20 participants, of which 9 were infected when using both products.
Of the nine participants, the time of the first infection showed a significant advantage of 1% bitterness (p=0. 0129). Per-
The protocol analysis shows only trends, as the population included is not sufficient to prove the importance.
There are no serious adverse events, there are only two possible adverse events related to treatment, one is short red spot and the other is a rash that has subsided after 5 days.
Conclusion the conventional use of 1% alcohol spray can effectively prevent the occurrence of pests.
The conclusion is that this product is effective if applied regularly and thoroughly.
Registration number isrctn095 24995
Despite the recent development of therapeutic products that are not affected by pesticide resistance, head lice infections are still prevalent.
There are many treatment options in European countries, however, some children are repeatedly infected despite being effective for most users.
Sometimes this is because the caregiver is unsuccessful in using the treatment, but children who have recently been treated will soon be infected again.
When discussing with the parents concerned, most of them, in addition to effective treatment, want to have a product that protects the child from infection.
Some people interpret this as the use of insect repellent.
However, in essence, insect repellent is volatile and therefore does not last long for hair, which means that they have a limited life span, especially if the application is not thorough.
2 also, as the lice crawl from head to head instead of looking for a host, the chemicals intended to disrupt the host-
Looking for function in flying insects may not have any activity on crawling lice.
In any case, it is recognized that the effectiveness of mosquito repellent is limited, so users may be bitten occasionally.
If similar failures occur on lice, the infection may be established without being noticed.
In the past, it was mistakenly believed that pesticides with residual effects could prevent re-infection in a few weeks.
This may be effective for some, but the effects of the residue are inconsistent and systematically filtered out by shampooing, so that the level of the pesticide is fast for any lice transferred to the hair
3-6 inevitably, at the beginning of 1990, lice exposed to low-level pesticides were selected to develop resistance to the proposed pesticides and malion pesticides.
7 Another prevention strategy is to use a product on a regular basis to prevent lice from contracting rather than repelling them.
This has never been true for traditional pesticides, and while anecdotal evidence suggests it may have been widely used, it is acceptable to use low-dose cosmetics on a regular basis, the physical action chemicals that destroy the skin lipids of the lice should kill the insects in contact with the treated hair and limit the risk of infection.
We know 1, 2-
Xin alcohol 5% is effective in eliminating identified head lice infections.
We also observed in the 1, 2-pre-clinical study
1% solutions are able to kill lice and, although slower, also suppress spawning.
This report describes a random, doubleblind, cross-
At the end, clinical study of spray containing 1% 1,2-
Compared to placebo, the bitterness developed as a preventive measure of this type.
Materials and methods sparticipantswe recruits participants in a manner similar to local radio advertising and writing to families who have participated in previous clinical trials and expressed their desire to participate in further studies.
A manual of information was sent to potential participants and if they wish to attend after reading, they will make an appointment to start the study on a suitable date.
Unlike other studies, only the youngest members of the school-going family were recruited for the study.
Therefore, the minimum age is 4 years and the maximum age is 16 years.
Other family members are not included, so they can be a potential source of infection for participants.
Each person who joins is done through a standardized consent/consent procedure, and then the presence of head lice is evaluated using a plastic head lice detection comb (
KSL Consulting, Denmark.
This is primarily intended to provide information about the person\'s current risk profile as everyone is treated to ensure that all participants are starting to be protected from infection.
Other family members who were infected at the time were treated to reduce the risk that index members would face immediate re-infection pressure.
All participants provided baseline data on age, gender and hair traits, as well as information on current medications and medical history.
All treatments and assessments were performed at the participant\'s home.
Participation fees are not paid.
As noted above, the age of eligibility and inclusion criteria is appropriate;
There is a risk of re-infection, based on previous individuals and family history, and is willing to participate in an estimated 14-week study.
Exclusion criteria are a history of allergies or sensitivity to test products or placebo ingredients; of long-
Diseases of the scalp, such as impeachment or psoriasis;
Pregnancy or breastfeeding within 1 month of entry and participation in other clinical studies.
The clinical trials of EthicsA have also been notified to the UK\'s drug and health care product regulatory authorities, referring to CI/2012/0032.
Parents provide written consent for participating children.
Written consent was also provided by the participants.
The general practitioner of each participant was informed that they had participated in the event.
The study was conducted in accordance with the principles of the Helsinki Declaration and the International Coordination Conference (ICH)
Guidelines for good clinical practice and European standards (GCP).
This is a random, double. blind, cross-
Over-study of 1% 1,2-
The bitterness in the hair-
Conditioning base (
The protection and development of Thornton rose Co. , Ltd. .
Trigger spray high density polyethylene with 100 (HDPE)
Plastic bottles like fake
In The detangler conditioning spray, used twice a week for washing and towelsdried hair.
6-more frequent applications are allowed during the period
For example, use a week if participants wash their hair more often.
The placebo-controlled subjects were ostensibly identical and applied in the same manner and at the same speed.
Both methods need to shake before application and warn not to spray on the face to prevent eye irritation.
At the time of registration and cross-registration
Between the use of different therapeutic sprays, we provided treatment to all participants to eliminate any lice that already exist, even if no lice were found.
For this we used dimeticone 4% liquid gel (
Liquid gel used to be in Thornton and roslín, UK)
Apply for 15 minutes before washing and repeat treatment after 7 days, which is not absolutely necessary due to the high level of efficacy of the product, 9 but the second application is the requirement of the Drug and Health Products Regulatory Authority to approve the study (MHRA)assessor.
We use the same product to treat infections acquired by participants and family members during the study.
Participants who were found to be infected at any time were not withdrawn.
The investigators were treated.
During the use of dimeticone liquid gel, the infected participants continued to use the spray they specified as this therapeutic product was
Residue, so there is no protective effect between treatment.
At the beginning of the study, a manual was provided to parents/carers (s)
For the use of spray.
Once a week, an investigator visits each family, uses a test comb to check if the participant has lice, provides a new bottle of spray, and returns the used bottle to the research center for weighing, to determine the number of uses.
Definition of infection we expect to find some lice when using preventive spray, as participants may have found lice at school in the afternoon before the visit.
So unless there are five or more big lice (
Adult and Stage 3 nymphs)
Or if there\'s a fairy (
Phase I and Phase II nymphs)present.
Both evidence suggests that it has been a while.
Only when eggs are laid Will Young nymphs appear, and most of the re-infection events begin from less than five adult or third stage nymphs.
If any stage of lice is found during two consecutive visits, this is considered to be the primary evidence of persistent infection.
When the infection is confirmed, with the exception of dimeticone 4% liquid gel, the application is used twice a week for treatment, and any lice found are fixed in the case record with transparent tape as confirmation.
At the end of the next 12 weeks --
The assessors noted whether there were live lice.
Lice were found in previous evaluations but no action was taken.
There are more than five lice.
There are nymphs in the first or second stages.
If the assessor finds a live tick (‘1’)
If either of the \"2\", \"3\" or \"4\" is applied at the same time, this is considered an active infection.
Collect and secure the lice in the case book and treat the participants to eliminate the infection.
After laboratory tests, the number of lice and the total number of lice at each developmental stage were recorded.
The purpose of the study was to demonstrate that, in the case of frequent use, 1% Xin alcohol spray can prevent head lice infection by killing any lice crawling on treated hair.
Unlike insect repellent, we recognize that lice will not be suppressed to climb on the head, but if applied correctly, the product should be suppressed, effectively limiting the risk of human infection using it.
The main outcome measurement is the time of the first infection, identified by systematic detection of the entire head.
The secondary end point is whether an infection occurs at any time when using the product, and the safety of the spray in use.
The aim of this study was to detect the superiority of 1% bitterness products compared with placebo.
This study is an unusual type for clinical studies because, unlike most clinical studies, participants in this study do not yet have a therapeutic disease.
The purpose of preventing preventable diseases is also different from other \"preventive\" studies, such as vaccine trials, since these studies are often long-term
The long-term population study attracted a large number of participants, who overall had a small detectable probability of failure.
We put forward a cross
Because it allows less participants to participate in the design, it also allows each participant to act as his/her own control.
Development Design is difficult, because the risk factors of each person are unknown, so only random may not completely solve the difference in infection risk caused by social and family environment, especially in a relatively small study queue.
Therefore, since
Controlling everyone is an attractive option to avoid any deviation caused by these unknown factors.
Preliminary analysis based on timeto-
The beginning of the first infection was considered a more effective way to detect the difference between 1% bitterness and placebo than a simpler method based on whether the participants were infected.
Sample size calculation of statistical consultants (
See online supplementary documents)
10 K simulation based on crossover
In studies using a range of defined study sizes, the power to detect significant differences in 95% CI was set, and then the minimum sample size was estimated to obtain a power of 80% or 90%.
For the risk of infection, we examined the participants\' experience in previous studies of re-infection three to five times a year, estimated to be equivalent to a rate of approximately 6-10% per person per week.
Therefore, when using active spray, we expect the risk to be reduced by 60% to 70%.
Therefore, we selected the sample size of 68 participants based on the hypothetical placebo weekly infection rate of 6%, and 2%, based on the estimated sample size of 64 times 80% times plus the drop-out allowance.
The weekly survival rate of these comparable to placebo was 94%, and the survival rate of Xin alcohol was 98%, or 6-
The weekly survival rate was 69% and 88, respectively. 6%.
This sample size gives 19 expectations.
Possible effects of placebo and 7.
In the course of the study, No. 8 was used for bitterness.
Random allocation: allocation hidden random treatment allocation code is generated using a free online random service with seed number 26 u2005 438 created in October 10, 2012.
Treatment is allocated in 8 balance blocks of 10 treatments, and if replacement is required, a spare block is randomly assigned.
Handles the anonymous identification of the distribution containing the product to be used and the application instructions.
The product identification/instruction manual is sealed in an opaque sequential numbered envelope with participant numbers taken from a random schedule.
The study is at a cross
Each participant was over-designed as their own control, so all participants used both preparations during the study.
Product Code is not broken until data collection is completed, data entry into research database and database locking.
Statistical analysis of differences between test treatments
In design and based on internal
Differences between the efficacy of 1% bitterness and placebo in the respective 6-process participants
Treatment period of the week
PN Lee Statistics and Computing Co. , Ltd. conducted major data management and analysis in collaboration with investigators.
Analyze binary data using McNemar test and use the Wilcoxon symbol-
Mapping test for paired data.
We performed an overall and separate analysis of participants in each random Group, based on the treatment they received first.
For the time when the infection was first confirmed, we used 7-
Ranking of points scored by participants: 1 = first confirmed infection
Up assment2 = the first time it happens when it happens the second time --up assessment. . . .
6 = the first time occurred at the time of the sixth
Up assessment 7 = no confirmation of infection was made in six assessment endpoint analyses, including whether the infection occurred at any time, every 6-
Number and type of treatment cycles and adverse events.
For the main results, we used Kaplan-
Mel curve to illustrate the time pattern in which participants survived from infection when 1% bitter or placebo was used.
We did not use log-to test the difference between notability treatments
Because these two curves are not
Based on the independence of the same participants.
We analyzed the intention. to-treat (ITT)and per-protocol (PP)groups.
Before we start, we expect to have some people who drop out of school, mainly in the second 6-
Treatment time of week
To address this problem, if this is the case, we plan to conduct an analysis, assuming that this is caused by infection, allowing for dropping out of school.
So, in order to analyze the drop-out situation, we assume that an infection occurred in the following first week
This is impossible.
If this occurs during the first treatment period, then there is no data for the second treatment period, and we assume that in two 6-week periods.
However, based on previous experience in this community, we also expect that if a drop-out occurs, it will occur at a very low rate, there is no need to review or other specific measures to address the issues in the analysis.
We also analyzed baseline features to compare participants to products that were randomly first accepted.
Accurate testing of binary data using Fisher and Mann-
Whitney U test for counting and ranking variables.
Participants we recruited participants in a manner similar to the previous survey of local radio advertising and wrote to families who participated in previous clinical trials and expressed their desire to participate in further studies.
A manual of information was sent to potential participants and if they wish to attend after reading, they will make an appointment to start the study on a suitable date.
Unlike other studies, only the youngest members of the school-going family were recruited for the study.
Therefore, the minimum age is 4 years and the maximum age is 16 years.
Other family members are not included, so they can be a potential source of infection for participants.
Each person who joins is done through a standardized consent/consent procedure, and then the presence of head lice is evaluated using a plastic head lice detection comb (
KSL Consulting, Denmark.
This is primarily intended to provide information about the person\'s current risk profile as everyone is treated to ensure that all participants are starting to be protected from infection.
Other family members who were infected at the time were treated to reduce the risk that index members would face immediate re-infection pressure.
All participants provided baseline data on age, gender and hair traits, as well as information on current medications and medical history.
All treatments and assessments were performed at the participant\'s home.
Participation fees are not paid.
As noted above, the age of eligibility and inclusion criteria is appropriate;
There is a risk of re-infection, based on previous individuals and family history, and is willing to participate in an estimated 14-week study.
Exclusion criteria are a history of allergies or sensitivity to test products or placebo ingredients; of long-
Diseases of the scalp, such as impeachment or psoriasis;
Pregnancy or breastfeeding within 1 month of entry and participation in other clinical studies.
The clinical trials of EthicsA have also been notified to the UK\'s drug and health care product regulatory authorities, referring to CI/2012/0032.
Parents provide written consent for participating children.
Written consent was also provided by the participants.
The general practitioner of each participant was informed that they had participated in the event.
The study was conducted in accordance with the principles of the Helsinki Declaration and the International Coordination Conference (ICH)
Guidelines for good clinical practice and European standards (GCP).
This is a random, double. blind, cross-
Over-study of 1% 1,2-
The bitterness in the hair-
Conditioning base (
The protection and development of Thornton rose Co. , Ltd. .
Trigger spray high density polyethylene with 100 (HDPE)
Plastic bottles like fake
In The detangler conditioning spray, used twice a week for washing and towelsdried hair.
6-more frequent applications are allowed during the period
For example, use a week if participants wash their hair more often.
The placebo-controlled subjects were ostensibly identical and applied in the same manner and at the same speed.
Both methods need to shake before application and warn not to spray on the face to prevent eye irritation.
At the time of registration and cross-registration
Between the use of different therapeutic sprays, we provided treatment to all participants to eliminate any lice that already exist, even if no lice were found.
For this we used dimeticone 4% liquid gel (
Liquid gel used to be in Thornton and roslín, UK)
Apply for 15 minutes before washing and repeat treatment after 7 days, which is not absolutely necessary due to the high level of efficacy of the product, 9 but the second application is the requirement of the Drug and Health Products Regulatory Authority to approve the study (MHRA)assessor.
We use the same product to treat infections acquired by participants and family members during the study.
Participants who were found to be infected at any time were not withdrawn.
The investigators were treated.
During the use of dimeticone liquid gel, the infected participants continued to use the spray they specified as this therapeutic product was
Residue, so there is no protective effect between treatment.
At the beginning of the study, a manual was provided to parents/carers (s)
For the use of spray.
Once a week, an investigator visits each family, uses a test comb to check if the participant has lice, provides a new bottle of spray, and returns the used bottle to the research center for weighing, to determine the number of uses.
Definition of infection we expect to find some lice when using preventive spray, as participants may have found lice at school in the afternoon before the visit.
So unless there are five or more big lice (
Adult and Stage 3 nymphs)
Or if there\'s a fairy (
Phase I and Phase II nymphs)present.
Both evidence suggests that it has been a while.
Only when eggs are laid Will Young nymphs appear, and most of the re-infection events begin from less than five adult or third stage nymphs.
If any stage of lice is found during two consecutive visits, this is considered to be the primary evidence of persistent infection.
When the infection is confirmed, with the exception of dimeticone 4% liquid gel, the application is used twice a week for treatment, and any lice found are fixed in the case record with transparent tape as confirmation.
At the end of the next 12 weeks --
The assessors noted whether there were live lice.
Lice were found in previous evaluations but no action was taken.
There are more than five lice.
There are nymphs in the first or second stages.
If the assessor finds a live tick (‘1’)
If either of the \"2\", \"3\" or \"4\" is applied at the same time, this is considered an active infection.
Collect and secure the lice in the case book and treat the participants to eliminate the infection.
After laboratory tests, the number of lice and the total number of lice at each developmental stage were recorded.
The purpose of the study was to demonstrate that, in the case of frequent use, 1% Xin alcohol spray can prevent head lice infection by killing any lice crawling on treated hair.
Unlike insect repellent, we recognize that lice will not be suppressed to climb on the head, but if applied correctly, the product should be suppressed, effectively limiting the risk of human infection using it.
The main outcome measurement is the time of the first infection, identified by systematic detection of the entire head.
The secondary end point is whether an infection occurs at any time when using the product, and the safety of the spray in use.
The aim of this study was to detect the superiority of 1% bitterness products compared with placebo.
This study is an unusual type for clinical studies because, unlike most clinical studies, participants in this study do not yet have a therapeutic disease.
The purpose of preventing preventable diseases is also different from other \"preventive\" studies, such as vaccine trials, since these studies are often long-term
The long-term population study attracted a large number of participants, who overall had a small detectable probability of failure.
We put forward a cross
Because it allows less participants to participate in the design, it also allows each participant to act as his/her own control.
Development Design is difficult, because the risk factors of each person are unknown, so only random may not completely solve the difference in infection risk caused by social and family environment, especially in a relatively small study queue.
Therefore, since
Controlling everyone is an attractive option to avoid any deviation caused by these unknown factors.
Preliminary analysis based on timeto-
The beginning of the first infection was considered a more effective way to detect the difference between 1% bitterness and placebo than a simpler method based on whether the participants were infected.
Sample size calculation of statistical consultants (
See online supplementary documents)
10 K simulation based on crossover
In studies using a range of defined study sizes, the power to detect significant differences in 95% CI was set, and then the minimum sample size was estimated to obtain a power of 80% or 90%.
For the risk of infection, we examined the participants\' experience in previous studies of re-infection three to five times a year, estimated to be equivalent to a rate of approximately 6-10% per person per week.
Therefore, when using active spray, we expect the risk to be reduced by 60% to 70%.
Therefore, we selected the sample size of 68 participants based on the hypothetical placebo weekly infection rate of 6%, and 2%, based on the estimated sample size of 64 times 80% times plus the drop-out allowance.
The weekly survival rate of these comparable to placebo was 94%, and the survival rate of Xin alcohol was 98%, or 6-
The weekly survival rate was 69% and 88, respectively. 6%.
This sample size gives 19 expectations.
Possible effects of placebo and 7.
In the course of the study, No. 8 was used for bitterness.
Random allocation: allocation hidden random treatment allocation code is generated using a free online random service with seed number 26 u2005 438 created in October 10, 2012.
Treatment is allocated in 8 balance blocks of 10 treatments, and if replacement is required, a spare block is randomly assigned.
Handles the anonymous identification of the distribution containing the product to be used and the application instructions.
The product identification/instruction manual is sealed in an opaque sequential numbered envelope with participant numbers taken from a random schedule.
The study is at a cross
Each participant was over-designed as their own control, so all participants used both preparations during the study.
Product Code is not broken until data collection is completed, data entry into research database and database locking.
Statistical analysis of differences between test treatments
In design and based on internal
Differences between the efficacy of 1% bitterness and placebo in the respective 6-process participants
Treatment period of the week
PN Lee Statistics and Computing Co. , Ltd. conducted major data management and analysis in collaboration with investigators.
Analyze binary data using McNemar test and use the Wilcoxon symbol-
Mapping test for paired data.
We performed an overall and separate analysis of participants in each random Group, based on the treatment they received first.
For the time when the infection was first confirmed, we used 7-
Ranking of points scored by participants: 1 = first confirmed infection
Up assment2 = the first time it happens when it happens the second time --up assessment. . . .
6 = the first time occurred at the time of the sixth
Up assessment 7 = no confirmation of infection was made in six assessment endpoint analyses, including whether the infection occurred at any time, every 6-
Number and type of treatment cycles and adverse events.
For the main results, we used Kaplan-
Mel curve to illustrate the time pattern in which participants survived from infection when 1% bitter or placebo was used.
We did not use log-to test the difference between notability treatments
Because these two curves are not
Based on the independence of the same participants.
We analyzed the intention. to-treat (ITT)and per-protocol (PP)groups.
Before we start, we expect to have some people who drop out of school, mainly in the second 6-
Treatment time of week
To address this problem, if this is the case, we plan to conduct an analysis, assuming that this is caused by infection, allowing for dropping out of school.
So, in order to analyze the drop-out situation, we assume that an infection occurred in the following first week
This is impossible.
If this occurs during the first treatment period, then there is no data for the second treatment period, and we assume that in two 6-week periods.
However, based on previous experience in this community, we also expect that if a drop-out occurs, it will occur at a very low rate, there is no need to review or other specific measures to address the issues in the analysis.
We also analyzed baseline features to compare participants to products that were randomly first accepted.
Accurate testing of binary data using Fisher and Mann-
Whitney U test for counting and ranking variables.
We recruited 64 potential participants but one of them lost track-
It is OK after one pretreatment using dimeticone 4% liquid gel.
Since this person has not yet entered the stage of investigation treatment, we believe that they have not actually started to participate and should be removed from the analysis, leaving 63 registered participants in the ITT population, 34 times given to Sinol, it was followed by placebo, placebo was given 29 times, followed by Xinyi.
All participants were recruited from the surrounding area of Cambridge, England.
Most were recruited between October 22-20 and November 16.
All participants completed the two arms of the study halfwayMarch 2013.
Of those recruited, two participants did not complete the study, one withdrew and one lost trackup.
20 participants were so inconsistent in product use that we excluded them from the PP population for agreement bias.
The reasons for the exclusion can be divided into five types summarized in Figure 1: 6 participants accidentally used 7 bottles of the first study treatment and 5 bottles of the second study treatment, instead of six bottles per group;
The two received rescue treatment at the wrong time;
A lost track.
One fell out.
Two people were unable to assess three times in the agreed time window.
Some of them were also found to be in a group that did not apply products on a regular basis.
A total of 16 participants failed to apply the treatment correctly within the agreed protocol.
14 of them (
6 when using alcohol and 8 when using placebo)
Failed to use any spray for one or more weeks.
If the spray is applied only once in a given week, it is considered a slight protocol deviation when it should be applied at least twice.
However, repeated inconsistency in use is considered to be a major deviation and, therefore, for the analysis, the two were excluded from the PP population, because they only use spray once a week on three or more occasions.
Through the study, download the flow chart of participants in the new tabDownload powerpoint figure 1.
These participants were included in the ITT analysis but were excluded from the PP analysis.
Baseline data for 63 participants in the survey phase, 50 (79. 4%)
Girls and 18 years old (28. 6%)
The age is 10 years old or over, and the rest are 4-9 years old.
There was no significant difference in age and gender in the randomized grouping, and there was no significant difference in the size of the family, the number of members who had examined the lice in the family, or the number of people who had found the lice at baseline (table 1).
Of the family members who were diagnosed with lice but did not participate in the study, only one refused treatment to eliminate the lice.
Again, there is no difference between the random grouping in terms of hair length, curl degree or hair type.
However, there is an important (p
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