A Dose Ranging Study of Different Strengths of Spinosad Topical Creme in Subjects With Pediculosis Capitis
The primary objective of the study is to determine the safety and efficacy of different strengths of Spinosad topical creme, as compared to a vehicle control, in subjects who have been infested with at least a mild case of Pediculosis capitis (head lice).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Phase 2 Study of Efficacy and Safety of Different Strengths of Spinosad Topical Creme Rinse (0%, 0.5% or 1.0%) in Subjects 2 Years of Age or Older With Pediculosis Capitis - A Dose Ranging Study|
- Efficacy variable: The presence/absence of live lice and/or nits at Day 7 and Day 14.
- Safety Analyses: The assessment of safety will be based on frequency of adverse events and on the scalp evaluations for irritation.
|Study Start Date:||March 2006|
|Estimated Study Completion Date:||July 2006|
There are millions of children and adults affected with head lice each year in the United States. It has become a major nuisance in school children resulting in many lost school days and frustrated parents. Lice and nit (ova) resistance to current OTC products has been reported. Compliance with product instructions is thought to be low. Therefore a safe and effective alternative to these products is desirable.
Spinosad and its formulations have been approved by the Environmental Protection Agency as crop protection products in the US, Canada and Australia, and has received provisional approval in the UK, Spain and several other European Union countries.
Spinosad is being formulated as a creme rinse using excipients that are widely used and are "generally regarded as safe" (GRAS).
This study is intended to show the safety and efficacy of Spinosad 0.5% and 1.0%, as compared to the vehicle control in subjects 2 years of age and older with at least a mild infestation of pediculosis capitis.
|United States, Arizona|
|Hill Top Resesarch|
|Scottsdale, Arizona, United States, 85251|
|United States, Florida|
|Hill Top Research|
|West Palm Beach, Florida, United States, 33409|
|United States, Ohio|
|Hill Top Research|
|Miamiville, Ohio, United States, 45147|
|Principal Investigator:||Dyal Garg, PhD||Hill Top Research|
|Principal Investigator:||Robert Lewine, MD||Hill Top Research|
|Principal Investigator:||Michael Noss, MD||Hill Top Research|