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| Sponsored by: |
Dow Pharmaceutical Sciences |
| Information provided by: | Dow Pharmaceutical Sciences |
| ClinicalTrials.gov Identifier: | NCT00664248 |
Purpose
The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with acne vulgaris.
| Condition | Intervention | Phase |
|
Acne Vulgaris |
Drug: IDP-110 Drug: Clindamycin Drug: Benzoyl peroxide Drug: Vehicle |
Phase III |
| MedlinePlus related topics: | Acne |
| ChemIDplus related topics: | Benzoyl peroxide Clindamycin Clindamycin hydrochloride Clindamycin palmitate Clindamycin Palmitate Hydrochloride Clindamycin phosphate |
| 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
|
| 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
|
Eligibility
| Ages Eligible for Study: | 12 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations![]() |
Show 35 Study Locations |
| Dow Pharmaceutical Sciences |
More Information
| Responsible Party: | Dow Pharmaceutical Sciences ( Barry M. Calvarese, MS / Vice President, Regulatory & Clinical Affairs ) |
| Study ID Numbers: | DPSI-06-22-2006-012 |
| First Received: | April 15, 2008 |
| Last Updated: | April 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00664248 |
| Health Authority: | United States: Food and Drug Administration |
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