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| Tracking Information | |||||
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| First Received Date ICMJE | April 30, 2008 | ||||
| Last Updated Date | September 5, 2008 | ||||
| Start Date ICMJE | December 2007 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Percent change from baseline in total lesion counts at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00671749 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris | ||||
| Official Title ICMJE | A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris | ||||
| Brief Summary | This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris. |
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| Detailed Description | Same as above. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Acne Vulgaris | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | August 2008 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: 1. Subjects with more than three nodulo-cystic lesions |
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| Gender | Both | ||||
| Ages | 12 Years to 35 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00671749 | ||||
| Responsible Party | Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P. | ||||
| Study ID Numbers ICMJE | US10066 | ||||
| Study Sponsor ICMJE | Galderma Laboratories, L.P. | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Galderma Laboratories, L.P. | ||||
| Verification Date | September 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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