A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse
Completed · Phase 2
Conditions studied: Pediculosis Capitis, Head Lice
In brief
A pilot study to compare the safety and efficacy of NatrOVA Creme Rinse 1% to NIX Creme Rinse in subjects with Pediculosis Capitis
Key facts
- Study ID
- NCT00857935
- Run by
- ParaPRO LLC
- People needed
- 24
- Starts
- 2007-03-01
- Expected to finish
- 2007-04-01
- Last updated by the study team
- 2009-03-09
Who can join
Age: 1 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Concentrics Research — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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