Status:
COMPLETED
A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse
Lead Sponsor:
ParaPRO LLC
Conditions:
Pediculosis Capitis
Head Lice
Eligibility:
All Genders
6+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00857935
Start Date
March 1 2007
End Date
April 1 2007
Last Update
March 9 2009
Active Locations (1)
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1
Concentrics Research
Indianapolis, Indiana, United States, 46240