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Sponsored by: |
ParaPro Pharmacuticals |
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Information provided by: | ParaPro Pharmacuticals |
ClinicalTrials.gov Identifier: | NCT00545168 |
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 | Intervention | Phase |
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Pediculosis Capitis (Head Lice) |
Drug: Spinosad Creme Rinse Drug: Permethrin 1% |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (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 With Pediculosis Capitis |
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 |
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A: Experimental
NatrOVA Creme Rinse - 1% - no nit combing required
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Drug: Spinosad Creme Rinse
10 minute topical application of product, followed by a complete rinse off.
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B: Experimental
NatrOVA Creme Rinse - 1% - nit comb regimen required
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Drug: Spinosad Creme Rinse
10 minute topical application followed by a complete rinse off, followed by a nit combing regimen.
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C: Active Comparator
Nix Creme Rinse applied according to OTC Instructions for Use
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Drug: Permethrin 1%
Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen
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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.
Ages Eligible for Study: | 6 Months and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Lice Solutions Network, Inc. | |
West Palm Beach, Florida, United States, 33407 | |
Advanced Dermatology and Cosmetic Surgery | |
Ormond Beach, Florida, United States, 32174 | |
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 |
Study Director: | Bill Miller, MD | Concentrics Research |
Responsible Party: | ParaPRO, LLC ( William Culpepper, III ) |
Study ID Numbers: | SPN-302-07 |
Study First Received: | October 15, 2007 |
Last Updated: | May 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00545168 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Lice Infestations Skin Diseases, Infectious Skin Diseases Permethrin Parasitic Diseases |
Lice Infestations Ectoparasitic Infestations Skin Diseases, Infectious Molecular Mechanisms of Pharmacological Action Skin Diseases |
Skin Diseases, Parasitic Permethrin Enzyme Inhibitors Parasitic Diseases Pharmacologic Actions |