A Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice
This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
First received: February 12, 2013
Last updated: March 1, 2013
Last verified: March 2013
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Controlled, Investigator-blinded, Comparative Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice|
Resource links provided by NLM:
Further study details as provided by Oystershell NV:
Primary Outcome Measures:
- proportion of subjects lice free at the end of the study (Day 10) [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- the proportion of subjects lice free at each of the intermediate evaluations (Day 1, Day 7) [ Time Frame: Day 1, Day 7 ] [ Designated as safety issue: No ]
Other Outcome Measures:
- eye irritation [ Time Frame: Day1, Day7, Day10 ] [ Designated as safety issue: Yes ]
- scalp condition [ Time Frame: Day0, Day1, Day7, Day10 ] [ Designated as safety issue: Yes ]
- Adverse events collection [ Time Frame: Day1, Day7, Day10 ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
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.
Active Comparator: RID shampoo
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|
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