Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice
A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse, under actual use conditions in subjects 6 months of age or greater who are infested with Pediculosis capitis (Head lice).
Pediculus Capitis Infestation
Drug: Permethrin 1%
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 3 Comparative Safety and Efficacy Study Between NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects > 6 Months of Age With Pediculosis Capitis|
- Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice [ Time Frame: Assessment were made 14 days following the final product treatment ] [ Designated as safety issue: No ]The primary efficacy endpoint was the proportion of primary subjects in the enrolled households who were lice free (no live lice, adults or nymphs), as assessed by the trained evaluator, 14 days after the last treatment (i.e., Day 14 for subjects who treated once and Day 21 for subjects who treated twice).
- Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. [ Time Frame: Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments) ] [ Designated as safety issue: Yes ]To evaluate the safety of NatrOVA® 1% Creme Rinse based upon reported adverse events and observed skin/scalp reactions. Additional safety assessments included cutaneous/ocular irritation.
|Study Start Date:||September 2007|
|Study Completion Date:||May 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Experimental: A - NatrOVA 1% - no nit combing
NatrOVA Creme Rinse (spinosad) 1% - no nit combing required
10 minute topical application of product, followed by a complete rinse off.
Experimental: B - NatrOVA 1% - nit combing required
NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
10 minute topical application followed by a complete rinse off, followed by a nit combing regimen.
Active Comparator: C - NIX
Nix Creme Rinse (permethrin 1%) applied according to OTC Instructions for Use
Drug: Permethrin 1%
Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen
Other Name: NIX Creme Rinse
This is a Phase 3 multi-site, randomized, evaluator/investigator-blinded, three-arm, parallel group study evaluating the safety and efficacy of NatrOVA Creme Rinse - 1% (with nit combing and without nit combing) versus NIX Creme Rinse in an "actual use" environment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545168
|United States, Florida|
|Advanced Dermatology and Cosmetic Surgery|
|Ormond Beach, Florida, United States, 32174|
|Lice Solutions Network, Inc.|
|West Palm Beach, Florida, United States, 33407|
|United States, Indiana|
|Concentrics Center for Research|
|Indianapolis, Indiana, United States, 46240|
|United States, Iowa|
|Alegent Health Clinic|
|Council Bluffs, Iowa, United States, 51503|
|United States, Texas|
|Corpus Christi, Texas, United States, 78411|
|United States, Utah|
|Wee Care Pediatrics|
|Layton, Utah, United States, 84041|
|Study Director:||Bill Miller, MD||Concentrics Research|