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

Sponsor:	ParaPro Pharmacuticals
Information provided by:	ParaPro Pharmacuticals
ClinicalTrials.gov Identifier:	NCT00545753

Purpose

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).

Condition	Intervention	Phase
Pediculosis Capitis(Head Lice)	Drug: Spinosad Creme Rinse Drug: Permethrin 1%	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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 or Older With Pediculosis Capitis

Resource links provided by NLM:

Drug Information available for: Permethrin Spinosad

U.S. FDA Resources

Further study details as provided by ParaPro Pharmacuticals:

Primary Outcome Measures:

Efficacy of NatrOVA Creme Rinse - 1% relative to NIX Creme rinse in subjects infested with head lice [ Time Frame: Assessment will be made 14 days following the final product treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluation of the safety of NatrOVA Creme Rinse - 1% based upon reported adv erse events and observed skin/scalp reactions. [ Time Frame: Throughout the study duration ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	510
Study Start Date:	September 2007
Study Completion Date:	May 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental NatrOVA Creme Rinse - 1% - no nit combing required	Drug: Spinosad Creme Rinse 10 minute topical application product, following by a complete rinse off.
B: Experimental NatrOVA Creme Rinse - 1% - nit comb regimen required	Drug: Spinosad Creme Rinse 10 minute topical application followed by a complete rinse off, followed by a nit combing regimen
C: Active Comparator NIX Creme Rinse applied 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

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

Ages Eligible for Study:	6 Months and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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 corticosteriods, anthralin, vitamin D analogs, retinoids, immunosuppressants, topical hair growth formulations, and topical dandruff treatments.
Infested subjects who have been previously treated with a pediculicide withini 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545753

Locations

United States, Arizona
Hill Top Research
Scottsdale, Arizona, United States, 85251
United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
United States, California
Impact Clinical Trials
Beverly Hills, California, United States, 90211
United States, Florida
DMI Healthcare Group
Largo, Florida, United States, 33773
United States, Ohio
Haber Dermatology & Cosmetic Surgery
South Euclid, Ohio, United States, 44118
Hill Top Research
Miamiville, Ohio, United States, 45147

Sponsors and Collaborators

ParaPro Pharmacuticals

Investigators

Study Director:

Bill Miller, MD

Concentrics Research

More Information

No publications provided

Responsible Party:	ParaPRO, LLC ( William Culpepper, III )
Study ID Numbers:	SPN-301-07
Study First Received:	October 15, 2007
Last Updated:	May 16, 2008
ClinicalTrials.gov Identifier:	NCT00545753 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by ParaPro Pharmacuticals:

Human Head lice

Additional relevant MeSH terms:

Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Infectious
Molecular Mechanisms of Pharmacological Action
Skin Diseases

Skin Diseases, Parasitic
Permethrin
Enzyme Inhibitors
Parasitic Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2009