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

NCT ID: NCT00545753

Last Updated: 2012-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 558 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-05-31

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 (human 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.

Conditions

Pediculosis

Keywords

Human Head lice

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A - NatrOVA 1% - no nit combing

NatrOVA Creme Rinse (spinosad) 1% - no nit combing required

Group Type: EXPERIMENTAL

Spinosad

Intervention Type: DRUG

10 minute topical application product, following by a complete rinse off.

B - NatrOVA 1% - nit combing required

NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required

Group Type: EXPERIMENTAL

Spinosad

Intervention Type: DRUG

10 minute topical application followed by a complete rinse off, followed by a nit combing regimen

C - NIX

NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use

Group Type: ACTIVE_COMPARATOR

Permethrin 1%

Intervention Type: DRUG

Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen

Interventions

Spinosad

10 minute topical application product, following by a complete rinse off.

Intervention Type: DRUG

Spinosad

10 minute topical application followed by a complete rinse off, followed by a nit combing regimen

Intervention Type: DRUG

Permethrin 1%

Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen

Intervention Type: DRUG

Other Intervention Names

Natroba (spinosad) Topical Suspension, 0.9%; Natroba (spinosad) Topical Suspension, 0.9%; NIX Creme Rinse

Eligibility 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.

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ParaPRO LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bill Miller, MD

Role: STUDY_DIRECTOR

Concentrics Research

Locations

Hill Top Research

Scottsdale, Arizona, United States

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Impact Clinical Trials

Beverly Hills, California, United States

DMI Healthcare Group

Largo, Florida, United States

Hill Top Research

Miamiville, Ohio, United States

Haber Dermatology & Cosmetic Surgery

South Euclid, Ohio, United States

Countries

United States

Other Identifiers

SPN-301-07

Identifier Type: -

Identifier Source: org_study_id