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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
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).
Details
| Lead sponsor | ParaPRO LLC |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 120 |
| Start date | 2006-03 |
| Completion | 2006-07 |
Conditions
- Pediculosis Capitis (Head Lice)
Interventions
- Spinosad Creme Rinse
Primary outcomes
- 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.
Countries
United States