Safety and Efficacy Study to Compare a 4% Dimethicone Foam and Nix Cream Rinse (1% Permethrin) in the Control of Head Lice
This study has been completed.
Information provided by:
First received: May 2, 2008
Last updated: May 5, 2008
Last verified: May 2008
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Randomized Study to Compare the Safety and Efficacy of Silcap Plus (Approximately 4% Dimeticone) Against Nix Cream Rinse.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Oystershell NV:
Primary Outcome Measures:
- 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). [ Time Frame: 14 or 15 days after 1st treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Any adverse events during or after application of the product [ Time Frame: up to 7 or 8 d after product application ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2007|
|Study Completion Date:||November 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
4% dimethicone foam
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.
Other Name: Oxykal, Neo-paraderma
Active Comparator: 2
Other: 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.
Other Name: Nix cream rinse
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