Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice
- Conditions
- Pediculus Capitis Infestation
- Interventions
- Registration Number
- NCT00545168
- Lead Sponsor
- ParaPRO LLC
- Brief Summary
A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse, under actual use conditions in subjects 6 months of age or greater who are infested with Pediculosis capitis (Head lice).
- Detailed Description
This is a Phase 3 multi-site, randomized, evaluator/investigator-blinded, three-arm, parallel group study evaluating the safety and efficacy of NatrOVA Creme Rinse - 1% (with nit combing and without nit combing) versus NIX Creme Rinse in an "actual use" environment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
- Subjects must have an active head lice infestation present at Day 0.
- Subjects can be female or male, at least 6 months of age.
- Subjects must be in good general health based on medical history.
- Each subject must have an appropriately signed Informed Consent agreement. Subjects under the age of 12 must also provide written or oral assent.
- The subject/caregiver must be able to read English or Spanish at a 7th grade level.
- The parent or guardian within a household must be willing to allow other household members to be screened for head lice. If other household members are found to have a head lice infestation, they should also be enrolled in the study.
- Subjects must agree to not use any other form of lice treatment during the course of the study and must agree not to use any of the excluded concomitant medications.
- Subjects must agree not to cut or chemically treat their hair in the period between the initial treatment and the final visit.
- Subjects/caregiver must demonstrate a clear understanding of his/her requirements for study participation and agree to comply with study instructions.
- Individuals with history of irritation or sensitivity to pediculicides or hair care products.
- Individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel or Sponsor, will interfere with the evaluation.
- Individuals who require treatment with topical salicylic acid, topical corticosteroids, anthralin, vitamin D analogs, retinoids, immunosuppressants, topical hair growth formulations, and topical dandruff treatments.
- Infested subjects who have been previously treated with a pediculicide within the 48 hours prior to the study.
- Individuals with a condition or illness that, in the opinion of the Investigator, may compromise the objective of the protocol.
- Individuals receiving systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel or study monitor may interfere with the study results.
- Individuals who have participated in a clinical trial within the past 30 days.
- Individuals (or individuals from households) who, in the opinion of the Investigator, do not understand the requirements for study participation and/or may be likely to exhibit poor compliance.
- Individuals with household 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. Females of childbearing potential must have a negative urine pregnancy test prior to treatment at Day 0. If a household has a pregnant female with an active case of head lice, the entire household is excluded from participation. If the pregnant household member does not have lice, this individual must NOT be the caregiver (one who provides treatment to other household members).
- Sexually active females not using effective contraception.
- Individuals who have a history of drug abuse in the past year.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B - NatrOVA 1% - nit combing required Spinosad NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required C - NIX Permethrin 1% Nix Creme Rinse (permethrin 1%) applied according to OTC Instructions for Use A - NatrOVA 1% - no nit combing Spinosad NatrOVA Creme Rinse (spinosad) 1% - no nit combing required
- Primary Outcome Measures
Name Time Method Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice Assessment were made 14 days following the final product treatment The primary efficacy endpoint was the proportion of primary subjects in the enrolled households who were lice free (no live lice, adults or nymphs), as assessed by the trained evaluator, 14 days after the last treatment (i.e., Day 14 for subjects who treated once and Day 21 for subjects who treated twice).
- Secondary Outcome Measures
Name Time Method Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments) To evaluate the safety of NatrOVA® 1% Creme Rinse based upon reported adverse events and observed skin/scalp reactions. Additional safety assessments included cutaneous/ocular irritation.
Trial Locations
- Locations (6)
Alegent Health Clinic
🇺🇸Council Bluffs, Iowa, United States
Advanced Dermatology and Cosmetic Surgery
🇺🇸Ormond Beach, Florida, United States
Wee Care Pediatrics
🇺🇸Layton, Utah, United States
Lice Solutions Network, Inc.
🇺🇸West Palm Beach, Florida, United States
Concentrics Center for Research
🇺🇸Indianapolis, Indiana, United States
Celia Reyes-Acuna
🇺🇸Corpus Christi, Texas, United States