Safety and Efficacy Study to Compare a 4% Dimethicone Foam and Nix Cream Rinse (1% Permethrin) in the Control of Head Lice

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the efficacy of a dimethicone foam in the control of head lice and to compare the efficacy to a permethrin based product.

Official Title
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An Open Label Randomized Study to Compare the Safety and Efficacy of Silcap Plus (Approximately 4% Dimeticone) Against Nix Cream Rinse.

Conditions
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Head Lice

Intervention / Treatment
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* Other: 4% dimethicone foam
* Other: 1% permethrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 4 - 85 years of age active head lice infestation of at least ≥ 10 live lice short hair (hair no longer than 2 inches below the neck) or long hair (hair 2 inches below the neck to mid back) Exclusion Criteria: had received or used an investigational new drug within the 30 days immediately preceding the study used any form of head lice treatment whether prescription, over-the-counter, or a home remedy for at least fourteen days prior to their study visit used topical medication of any kind on the hair for a period of 48 hours prior to the visit had a history of allergy to rag weed, permethrin, or mineral oil, or had taken trimethoprim or cotrimoxazole at evaluation or during the previous four weeks Female subjects that were pregnant or breast feeding

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 85 Years

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>4% dimethicone foam | Other: 4% dimethicone foam<br>* The dimethicone foam is applied to dry hair and left on the hair for approximately 15 minutes. The product is then removed by washing the hair with baby shampoo. The foam is applied two time, separated by an interval of 7-9 days.<br>* Other names: Oxykal, Neo-paraderma;|
| Active Comparator: 2<br>1% permethrin | Other: 1% permethrin<br>* Nix® Cream Rinse is applied as indicated on the product labeling. The cream rinse is applied to wet hair and left on the hair for 10 minutes. The hair is then rinsed with tepid water to remove the product, toweled dry, and combed with a detangling comb. The product is applied two times, separated by an interval of 7-9 days.<br>* Other names: Nix cream rinse;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate at the final visit (Day 14 or 15). Cure rate was defined as the number of subjects free of live head lice divided by the total number of subjects in the treatment group (x 100). |  | 14 or 15 days after 1st treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any adverse events during or after application of the product |  | up to 7 or 8 d after product application |