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

Head Lice Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00672971
• Other study ID #: OYS001-07
• Status: Completed
• Phase: N/A
• First received: May 2, 2008
• Last updated: May 5, 2008
• Start date: September 2007
• Est. completion date: November 2007

Study information

• Verified date: May 2008
• Source: Oystershell NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head Lice

Intervention

Other:
• 4% dimethicone foam
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.
• 1% permethrin
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.

Locations

Country	Name	City	State
United States	Lice Source Services Inc	Plantation	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Oystershell NV

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Any adverse events during or after application of the product		up to 7 or 8 d after product application	Yes