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

• ClinicalTrials.gov Identifier: NCT00545168
• Recruitment Status: Completed
• First Posted: October 17, 2007
• Results First Posted: October 11, 2012
• Last Update Posted: October 11, 2012
• Sponsor: ParaPRO LLC
• Information provided by (Responsible Party): ParaPRO LLC

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Pediculus Capitis Infestation	Drug: Spinosad; Drug: Permethrin 1%	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 480 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: September 2007
• Actual Primary Completion Date: March 2008
• Actual Study Completion Date: May 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: A - NatrOVA 1% - no nit combing; NatrOVA Creme Rinse (spinosad) 1% - no nit combing required	Drug: Spinosad; 10 minute topical application of product, followed by a complete rinse off.; Other Name: Natroba (spinosad) Topical Suspension, 0.9%
Experimental: B - NatrOVA 1% - nit combing required; NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required	Drug: Spinosad; 10 minute topical application followed by a complete rinse off, followed by a nit combing regimen.; Other Name: Natroba (spinosad) Topical Suspension, 0.9%
Active Comparator: C - NIX; Nix Creme Rinse (permethrin 1%) applied according to OTC Instructions for Use	Drug: Permethrin 1%; Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen; Other Name: NIX Creme Rinse

Outcome Measures

Primary Outcome Measures :

1. Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice [ Time Frame: 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 :

1. Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions. [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 6 Months and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Florida

Advanced Dermatology and Cosmetic Surgery

Ormond Beach, Florida, United States, 32174

Lice Solutions Network, Inc.

West Palm Beach, Florida, United States, 33407

United States, Indiana

Concentrics Center for Research

Indianapolis, Indiana, United States, 46240

United States, Iowa

Alegent Health Clinic

Council Bluffs, Iowa, United States, 51503

United States, Texas

Celia Reyes-Acuna

Corpus Christi, Texas, United States, 78411

United States, Utah

Wee Care Pediatrics

Layton, Utah, United States, 84041

Sponsors and Collaborators

ParaPRO LLC

Investigators

• Study Director: Bill Miller, MD; Concentrics Research

More Information

• Responsible Party: ParaPRO LLC
• ClinicalTrials.gov Identifier: NCT00545168
• Other Study ID Numbers: SPN-302-07
• First Posted: October 17, 2007
• Results First Posted: October 11, 2012
• Last Update Posted: October 11, 2012
• Last Verified: September 2012

Keywords provided by ParaPRO LLC:

head lice

Additional relevant MeSH terms:

Parasitic Diseases; Infections; Permethrin; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action