A Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Controlled, Investigator-blinded, Comparative Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice

Conditions
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Head Lice

Intervention / Treatment
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* Other: X92001327
* Other: RID shampoo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: X92001327<br>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. | Other: X92001327<br> <br> |
| Active Comparator: RID shampoo<br>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. | Other: RID shampoo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Day 1, Day 7 |