Conditions: Pediculus Capitis Infestation
Keywords: head lice
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 480
Healthy volunteers: yes

Brief summary:
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).

Detailed description:
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.

Arms:
arm 1: NatrOVA Creme Rinse (spinosad) 1% - no nit combing required arm 2: NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required arm 3: Nix Creme Rinse (permethrin 1%) applied according to OTC Instructions for Use

Interventions: intervention 1: Spinosad intervention 2: Spinosad intervention 3: Permethrin 1%
Intervention descriptions: intervention 1: 10 minute topical application of product, followed by a complete rinse off. intervention 2: 10 minute topical application followed by a complete rinse off, followed by a nit combing regimen. intervention 3: Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen

Protocol document: