Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice

Completed · Phase 3

Conditions studied: Pediculus Capitis Infestation

In brief

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).

Key facts

Study ID

NCT00545168

Run by

ParaPRO LLC

People needed

480

Starts

2007-09-01

Expected to finish

2008-05-01

Last updated by the study team

2012-10-11

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Advanced Dermatology and Cosmetic Surgery — Ormond Beach, Florida, United States
• Lice Solutions Network, Inc. — West Palm Beach, Florida, United States
• Concentrics Center for Research — Indianapolis, Indiana, United States
• Alegent Health Clinic — Council Bluffs, Iowa, United States
• Celia Reyes-Acuna — Corpus Christi, Texas, United States
• Wee Care Pediatrics — Layton, Utah, United States

Full record on ClinicalTrials.gov

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