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

Not Applicable

Completed

• Conditions: Head Lice
• Interventions: Other: 4% dimethicone foam; Other: 1% permethrin

• Registration Number: NCT00672971
• Lead Sponsor: Oystershell NV

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2008-05
• Study First Submitted: 2008-05-02
• Study First Submitted QC: 2008-05-05
• Last Update Submitted: 2008-05-05
• Study First Posted: 2008-05-06
• Last Update Posted: 2008-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	4% dimethicone foam	4% dimethicone foam
2	1% permethrin	1% permethrin

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Any adverse events during or after application of the product	up to 7 or 8 d after product application

Trial Locations

Locations (1)

Lice Source Services Inc; 🇺🇸 Plantation, Florida, United States