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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
480
10 minute topical application of product, followed by a complete rinse off.
10 minute topical application followed by a complete rinse off, followed by a nit combing regimen.
Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen
Advanced Dermatology and Cosmetic Surgery
Ormond Beach, Florida, United States
Lice Solutions Network, Inc.
West Palm Beach, Florida, United States
Concentrics Center for Research
Indianapolis, Indiana, United States
Alegent Health Clinic
Council Bluffs, Iowa, United States
Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice
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).
Time frame: Assessment were made 14 days following the final product treatment
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions.
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.
Time frame: Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)
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Celia Reyes-Acuna
Corpus Christi, Texas, United States
Wee Care Pediatrics
Layton, Utah, United States