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

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

A pilot study to compare the safety and efficacy of NatrOVA Creme Rinse 1% to NIX Creme Rinse in subjects with Pediculosis Capitis

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ParaPRO LLC
• Treatments: Permethrin

Criteria

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