A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse
Phase 2
Completed
- Conditions
- Pediculosis CapitisHead Lice
- Interventions
- Drug: NatrOVA Creme Rinse - 1%
- Registration Number
- NCT00857935
- Lead Sponsor
- ParaPRO LLC
- Brief Summary
A pilot study to compare the safety and efficacy of NatrOVA Creme Rinse 1% to NIX Creme Rinse in subjects with Pediculosis Capitis
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 NatrOVA Creme Rinse - 1% NatrOVA Creme Rinse - 1% 2 NIX Creme Rinse - 1% permethrin NIX Creme Rinse
- Primary Outcome Measures
Name Time Method Efficacy of NatrOVA Creme Rinse-1% versus NIX Creme rinse, based on the presence or absence of live lice 14 days after the final treatment. 14 days after last treatment
- Secondary Outcome Measures
Name Time Method Safety comparison between NatrOVA Creme Rinse-1% and NIX Creme Rinse, based on the occurrence of adverse events and any increase of scalp and/or ocular irritation, post-treatment. 14 days after last treatment
Trial Locations
- Locations (1)
Concentrics Research
🇺🇸Indianapolis, Indiana, United States