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Sponsored by: |
Dow Pharmaceutical Sciences |
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Information provided by: | Dow Pharmaceutical Sciences |
ClinicalTrials.gov Identifier: | NCT00666900 |
The purpose of this study is to assess the safety and effectiveness of IDP-107 in treating patients with acne vulgaris.
Condition | Intervention | Phase |
---|---|---|
Acne Vulgaris |
Drug: Low Strength IDP-107 Drug: High Strength IDP-107 Drug: Placebo Comparator |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Enrollment: | 366 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Low Strength IDP-107
Once a day for 12 weeks
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2: Experimental |
Drug: High Strength IDP-107
Once a day for 12 weeks
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3: Placebo Comparator |
Drug: Placebo Comparator
Once a day for 12 weeks
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Dow Pharmaceutical Sciences, Inc. ( Barry M. Calvarese, MS / Vice President, Regulatory & Clinical Affairs ) |
Study ID Numbers: | DPSI-IDP-107-P2-01 |
Study First Received: | April 23, 2008 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00666900 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Exanthema Facial Dermatoses Facies |
Skin Diseases Sebaceous Gland Diseases Acne Vulgaris |
Facial Dermatoses Skin Diseases Acneiform Eruptions Sebaceous Gland Diseases Acne Vulgaris |