Back to resultsA Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice
Primary Purpose
Head Lice
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
X92001327
RID shampoo
Sponsored by
About this trial
This is an interventional treatment trial for Head Lice
Eligibility Criteria
Inclusion Criteria:
- Male or female over the age of 1 at the time of signing the informed consent or giving assent
- Have an active head lice infestation of at least 5 live lice and 5 viable nits
- subject must be capable of understanding and providing written informed consent
- agree not to use any other pediculicides or medicated hair grooming products for the duration of the study
- agree not to use a lice comb during the study
- the parent or guardian of a child must be willing to have other family members screened for head lice.
- have a single place of residence
Exclusion Criteria:
- used any form of head lice treatment whether prescription or over the counter or home remedy at least four weeks prior to their screening visit
- used any topical medication of any kind for a period of 48 hours prior to the screening visit
- individuals on systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results
- has a history of allergy or hypersensitivity to ragweed, hydrocarbons, sesame oil, perfume or any ingredient in either test product
- individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel will interfere with the evaluation of the test product
- individuals who, in the opinion of the investigative personnel do not understand the subject requirements for study participation and/or may be likely to exhibit poor compliance with the required visits
- females who are pregnant or nursing
- patients that have taken trimethoprim or a combination of sulfamethoxazole at evaluation or during the previous 4 weeks
- subjects with hair longer than mid back
Sites / Locations
- Lice Source services Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
X92001327
RID shampoo
Arm Description
the X92001327 product is a lotion to be applied on dry hair for 15 minutes and then washed out using shampoo. The product is to be applied on Day 0 and repeated again on Day 7.
The RID shampoo is to be applied on dry the hair for 10 minutes and then rinsed out with water. the product is to be applied on Day 0 and repeated again on Day 7.
Outcomes
Primary Outcome Measures
The proportion of subjects lice free at the end of the study (Day 10)
Primary objective of this study was the cure rate (%) in each treatment group, following two applications (day 0 and day 7) of the specific test product, as assessed on the last evaluation visit (day 10).
Secondary Outcome Measures
The proportion of subjects lice free at each of the intermediate evaluations (Day 1, Day 7)
Secondary outcome involved the cure rate (%) in each treatment group, following one application of the specific test product, as assessed 24h post treatment (day 1) and on day 7 (prior to the second treatment).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01803581
Brief Title
A Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice
Official Title
A Randomized, Controlled, Investigator-blinded, Comparative Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 5, 2013 (Actual)
Primary Completion Date
June 20, 2013 (Actual)
Study Completion Date
August 12, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oystershell NV
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the efficacy and safety of an insecticide-free head lice product with that of a pyrethrum-based product.
Detailed Description
The primary objective of the study was to compare the safety and efficacy of X92001327 versus RID in subjects with head lice. The subjects received a single application on Day 0 of either X92001327 or RID shampoo based on the randomization schedule. A repeat application of the test product was administered on Day 7. Subjects visited the clinic four times: on Day 0, Day 1, Day 7 and Day 10.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Lice
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
X92001327
Arm Type
Experimental
Arm Description
the X92001327 product is a lotion to be applied on dry hair for 15 minutes and then washed out using shampoo. The product is to be applied on Day 0 and repeated again on Day 7.
Arm Title
RID shampoo
Arm Type
Active Comparator
Arm Description
The RID shampoo is to be applied on dry the hair for 10 minutes and then rinsed out with water. the product is to be applied on Day 0 and repeated again on Day 7.
Intervention Type
Other
Intervention Name(s)
X92001327
Intervention Type
Other
Intervention Name(s)
RID shampoo
Primary Outcome Measure Information:
Title
The proportion of subjects lice free at the end of the study (Day 10)
Description
Primary objective of this study was the cure rate (%) in each treatment group, following two applications (day 0 and day 7) of the specific test product, as assessed on the last evaluation visit (day 10).
Time Frame
Day 10
Secondary Outcome Measure Information:
Title
The proportion of subjects lice free at each of the intermediate evaluations (Day 1, Day 7)
Description
Secondary outcome involved the cure rate (%) in each treatment group, following one application of the specific test product, as assessed 24h post treatment (day 1) and on day 7 (prior to the second treatment).
Time Frame
Day 1, Day 7
Other Pre-specified Outcome Measures:
Title
Eye irritation
Description
As part of the evaluation of the safety profile of both test products, eye irritation has been evaluated at day 0 (prior to and after first treatment), day 1 (24h after the first treatment), day 7 (prior to and after second treatment) and day 10, respectively.
Time Frame
Day0, Day 1, Day7, Day10
Title
Scalp condition
Description
As part of the evaluation of the safety profile of both test products, scalp condition has been evaluated at day 0 (prior to and after first treatment), day 1 (24h after the first treatment), day 7 (prior to and after second treatment) and day 10, respectively.
Time Frame
Day0, Day1, Day7, Day10
Title
Adverse events collection
Description
Adverse events have been collected from the initial application of test product until completion of the final follow-up visit (day 10). For any adverse event, date of onset, intensity, seriousness and causal relationship to the study treatment have been recorded.
Time Frame
Day 0, Day1, Day7, Day10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female over the age of 1 at the time of signing the informed consent or giving assent
Have an active head lice infestation of at least 5 live lice and 5 viable nits
subject must be capable of understanding and providing written informed consent
agree not to use any other pediculicides or medicated hair grooming products for the duration of the study
agree not to use a lice comb during the study
the parent or guardian of a child must be willing to have other family members screened for head lice.
have a single place of residence
Exclusion Criteria:
used any form of head lice treatment whether prescription or over the counter or home remedy at least four weeks prior to their screening visit
used any topical medication of any kind for a period of 48 hours prior to the screening visit
individuals on systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results
has a history of allergy or hypersensitivity to ragweed, hydrocarbons, sesame oil, perfume or any ingredient in either test product
individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel will interfere with the evaluation of the test product
individuals who, in the opinion of the investigative personnel do not understand the subject requirements for study participation and/or may be likely to exhibit poor compliance with the required visits
females who are pregnant or nursing
patients that have taken trimethoprim or a combination of sulfamethoxazole at evaluation or during the previous 4 weeks
subjects with hair longer than mid back
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lidia Serrano
Organizational Affiliation
Lice Source Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lice Source services Inc
City
Plantation
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22715834
Citation
Barker SC, Burgess I, Meinking TL, Mumcuoglu KY. International guidelines for clinical trials with pediculicides. Int J Dermatol. 2012 Jul;51(7):853-8. doi: 10.1111/j.1365-4632.2011.05446.x.
Results Reference
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A Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice
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