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Sponsored by: |
Dow Pharmaceutical Sciences |
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Information provided by: | Dow Pharmaceutical Sciences |
ClinicalTrials.gov Identifier: | NCT00664248 |
The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with acne vulgaris.
Condition | Intervention | Phase |
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Acne Vulgaris |
Drug: IDP-110 Drug: Clindamycin Drug: Benzoyl peroxide Drug: Vehicle |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Enrollment: | 1414 |
Study Start Date: | October 2006 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: IDP-110
Topical application for 12 weeks
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2: Active Comparator |
Drug: Clindamycin
Topical application for 12 weeks
|
3: Active Comparator |
Drug: Benzoyl peroxide
Topical application for 12 weeks
|
4: Placebo Comparator |
Drug: Vehicle
Topical application for 12 weeks
|
Ages Eligible for Study: | 12 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Dow Pharmaceutical Sciences ( Barry M. Calvarese, MS / Vice President, Regulatory & Clinical Affairs ) |
Study ID Numbers: | DPSI-06-22-2006-012 |
Study First Received: | April 15, 2008 |
Last Updated: | April 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00664248 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Infective Agents Anti-Bacterial Agents Exanthema Clindamycin Facial Dermatoses Clindamycin-2-phosphate |
Facies Skin Diseases Benzoyl Peroxide Sebaceous Gland Diseases Acne Vulgaris |
Anti-Infective Agents Clindamycin Facial Dermatoses Skin Diseases Molecular Mechanisms of Pharmacological Action Benzoyl Peroxide Enzyme Inhibitors Sebaceous Gland Diseases |
Acne Vulgaris Pharmacologic Actions Anti-Bacterial Agents Protein Synthesis Inhibitors Acneiform Eruptions Therapeutic Uses Dermatologic Agents |