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A Comparative Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Pediculosis Capitis

Information source: ParaPro Pharmacuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pediculosis Capitis (Head Lice)

Intervention: Spinosad Creme Rinse (Drug); Spinosad Creme Rinse (Drug); Permethrin 1% (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: ParaPro Pharmacuticals

Official(s) and/or principal investigator(s):
Bill Miller, MD, Study Director, Affiliation: Concentrics Research

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).

Clinical Details

Official title: A Phase 3 Comparative Safety and Efficacy Study Between NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects > 6 Months of Age With Pediculosis Capitis

Study design: Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Efficacy of NatrOVA Creme Rinse - 1% relative to NIX Creme Rinse in subjects infested with head lice

Secondary outcome: Evaluation of the safety of NatrOVA Creme Rinse - 1% based upon reported adverse events and observed skin/scalp reactions

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.

Eligibility

Minimum age: 6 Months. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Subjects must have an active head lice infestation present at Day 0.

2. Subjects can be female or male, at least 6 months of age.

3. Subjects must be in good general health based on medical history.

4. Each subject must have an appropriately signed Informed Consent agreement. Subjects under the age of 12 must also provide written or oral assent.

5. The subject/caregiver must be able to read English or Spanish at a 7th grade level.

6. 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.

7. 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.

8. Subjects must agree not to cut or chemically treat their hair in the period between the initial treatment and the final visit.

9. Subjects/caregiver must demonstrate a clear understanding of his/her requirements for study participation and agree to comply with study instructions.

Exclusion Criteria:

1. Individuals with history of irritation or sensitivity to pediculicides or hair care products.

2. 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.

3. Individuals who require treatment with topical salicylic acid, topical corticosteroids, anthralin, vitamin D analogs, retinoids, immunosuppressants, topical hair growth formulations, and topical dandruff treatments.

4. Infested subjects who have been previously treated with a pediculicide within the 48 hours prior to the study.

5. Individuals with a condition or illness that, in the opinion of the Investigator, may compromise the objective of the protocol.

6. 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.

7. Individuals who have participated in a clinical trial within the past 30 days.

8. 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.

9. 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.

10. 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).

11. Sexually active females not using effective contraception.

12. Individuals who have a history of drug abuse in the past year.

Locations and Contacts

Lice Solutions Network, Inc., West Palm Beach, Florida 33407, United States

Advanced Dermatology and Cosmetic Surgery, Ormond Beach, Florida 32174, United States

Concentrics Center for Research, Indianapolis, Indiana 46240, United States

Alegent Health Clinic, Council Bluffs, Iowa 51503, United States

Celia Reyes-Acuna, Corpus Christi, Texas 78411, United States

Wee Care Pediatrics, Layton, Utah 84041, United States

Additional Information

Starting date: September 2007
Ending date: May 2008
Last updated: May 16, 2008

Page last updated: June 20, 2008

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