A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse

A Phase 2b, randomized, single-site, investigator/evaluator blind, two-arm, parallel-group pilot study that tested the operational elements of an "Actual Use" study designed to evaluate the safety and efficacy of a 10-minute treatment and no-nit combing regimen of NatrOVA Creme Rinse 1% versus NIX Creme Rinse in subjects with at least a mild case of head lice.

Inclusion criteria

• Male or female, 6 months of age or older
• Subject must have a head lice infestation present at baseline
• Subject/caregiver must read English or Spanish at a 7th grade level
• Subject must have an appropriately signed Informed Consent agreement
• Other members of the household with a lice infestation must be willing to be enrolled in the study or treat their infestations with a standard treatment
• Subject agreement to not use any other form of lice treatment during the course of the study
• Subject agreement to not cut or chemically treat their hair in the period between baseline and final, post-treatment visits

Exclusion criteria

• Individuals with a history of irritation or sensitivity to pediculicides or hair care products
• Individuals with any visible skin/scalp condition at the treatment site that could interfere with the evaluation
• Individuals previously treated with a pediculicide or any other head lice treatment product within 48 hours prior to enrollment
• Individuals receiving systemic or topical drugs that may interfere with the study results
• Individuals who have participated in a clinical trial within 30 days of enrollment
• Individuals with family members who are infested with lice but are unwilling or unable to enroll in the study or to use the standard course of lice treatment
• Females who are pregnant or nursing
• Sexually-active females not using effective contraception