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Sponsored by: |
ParaPro Pharmacuticals |
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Information provided by: | ParaPro Pharmacuticals |
ClinicalTrials.gov Identifier: | NCT00311779 |
The primary objective of the study is to determine the safety and efficacy of different strengths of Spinosad topical creme, as compared to a vehicle control, in subjects who have been infested with at least a mild case of Pediculosis capitis (head lice).
Condition | Intervention | Phase |
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Pediculosis Capitis (Head Lice) |
Drug: Spinosad Creme Rinse |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Phase 2 Study of Efficacy and Safety of Different Strengths of Spinosad Topical Creme Rinse (0%, 0.5% or 1.0%) in Subjects 2 Years of Age or Older With Pediculosis Capitis - A Dose Ranging Study |
Estimated Enrollment: | 120 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | July 2006 |
There are millions of children and adults affected with head lice each year in the United States. It has become a major nuisance in school children resulting in many lost school days and frustrated parents. Lice and nit (ova) resistance to current OTC products has been reported. Compliance with product instructions is thought to be low. Therefore a safe and effective alternative to these products is desirable.
Spinosad and its formulations have been approved by the Environmental Protection Agency as crop protection products in the US, Canada and Australia, and has received provisional approval in the UK, Spain and several other European Union countries.
Spinosad is being formulated as a creme rinse using excipients that are widely used and are "generally regarded as safe" (GRAS).
This study is intended to show the safety and efficacy of Spinosad 0.5% and 1.0%, as compared to the vehicle control in subjects 2 years of age and older with at least a mild infestation of pediculosis capitis.
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Hill Top Resesarch | |
Scottsdale, Arizona, United States, 85251 | |
United States, Florida | |
Hill Top Research | |
West Palm Beach, Florida, United States, 33409 | |
United States, Ohio | |
Hill Top Research | |
Miamiville, Ohio, United States, 45147 |
Principal Investigator: | Dyal Garg, PhD | Hill Top Research |
Principal Investigator: | Robert Lewine, MD | Hill Top Research |
Principal Investigator: | Michael Noss, MD | Hill Top Research |
Study ID Numbers: | SPN-202-06 |
Study First Received: | April 4, 2006 |
Last Updated: | July 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00311779 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pediculosis capitis Head Lice Crawlers Ova |
Lice Infestations Skin Diseases, Infectious Skin Diseases Parasitic Diseases |
Lice Infestations Ectoparasitic Infestations Skin Diseases, Infectious |
Skin Diseases Skin Diseases, Parasitic Parasitic Diseases |