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Sponsored by: |
Stiefel Laboratories |
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Information provided by: | Stiefel Laboratories |
ClinicalTrials.gov Identifier: | NCT00757523 |
The purpose of this study is to compare the effectiveness of two marketed products in subjects with facial acne vulgaris
Condition | Intervention | Phase |
---|---|---|
Acne Vulgaris |
Drug: Epiduo Gel Drug: Duac Gel |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | A Multi-Center, Randomized, Evaluator-Blind, Parallel-Group Evaluation of the Efficacy, Safety, and Tolerability of Duac Akne Gel and Epiduo Gel in the Topical Treatment of Facial Acne Vulgaris |
Enrollment: | 383 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Epiduo Gel: Active Comparator
Epiduo Gel (combination of 0.1% adapalene and 2.5% benzoyl peroxide (BPO) in a gel preparation).
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Drug: Epiduo Gel
Epiduo Gel (combination of 0.1% adapalene and 2.5% benzoyl peroxide (BPO) in a gel preparation). Treatments administered once-daily in the evening for 12 weeks
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Duac Gel: Experimental |
Drug: Duac Gel
Duac Akne Gel (combination of 1% clindamycin phosphate and 5% benzoyl peroxide (BPO) in a gel preparation). Treatments administered once-daily in the evening for 12 weeks
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Multiple physiopathological factors have been associated with acne vulgaris. Drug combinations are frequently used to address these factors and to improve efficacy in the treatment of acne. The current study proposes to compare a fixed-dose (once-daily) combination gel product containing benzoyl peroxide (BPO)and clindamycin against a fixed-dose (once-daily) combination gel product containing BPO and adapalene for the treatment of facial acne vulgaris.
Ages Eligible for Study: | 12 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Departments of Dermatology, Venreology, Allergology and Immunology, Dessau Medical Centre | |
Dessau, Germany, 06847 | |
Universitatsklinik Hamburg | |
Hamburg, Germany, 20246 | |
Department of Dermatology & Allergy | |
Bonn, Germany, 53105 | |
Dr Bockhorst/Dr Dominicus Practice | |
Duelmen, Germany, 48249 | |
Hautarzt Allergologe | |
Kiel, Germany, 24148 | |
Skin & Laser Centre Potsdam | |
Potsdam, Germany, 14469 | |
Hautaerzte and Laserzenrtrum Dr Fritz, Landau and Kandel | |
Landau, Germany, 76829 | |
University Clinic Giessen/Germany - Psychodermatology, | |
Giessen, Germany, 35392 | |
Dermatol Department Technical Univ. München | |
München, Germany, 80802 | |
Praxis Dr Dirk Grone | |
Berlin, Germany, 14052 | |
Department of Dermatology, Venereology, and Allergology, University of Essen | |
Essen, Germany, 45122 | |
Department of Dermatology, University of Frankfurt | |
Frankfurt, Germany, 60590 | |
Klinik und Poliklinik fur Dermatologie und Allergologie der LMU | |
München, Germany, 80337 | |
Praxis für Dermatologie, Allergologie, Ästhetische Dermatologie ünd Naturheilverfahren | |
Berlin,, Germany, 14169 | |
Department of Dermatology, University of Munster | |
Münster, Germany, 48149 | |
Institute for Applied Dermatopharmacy, Centre for Clinical Trials Dermatology | |
Halle, Germany, 06097 | |
Department of Dermatology and Venereology | |
Magdeburg, Germany, 39120 |
Study Director: | David G Angulo, MD | Stiefel Labortories, Inc., Sr. Director Global Clinical Research |
Principal Investigator: | Christos Zouboulis, MD | Departments of Dermatology, Venreology, Allergology and Immunology, Dessau Medical Centre |
Responsible Party: | Stiefel Laboratories, Inc. ( Jason Mann/Director, Global Clinical Operations ) |
Study ID Numbers: | S194 -401, Eudract No 2008-002359-26, The 'Duetta' study |
Study First Received: | September 21, 2008 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00757523 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Acne Acne Vulgaris Akne Akne Vulgaris |
Exanthema Clindamycin Facial Dermatoses Clindamycin-2-phosphate Skin Diseases |
Facies Benzoyl Peroxide Adapalene Sebaceous Gland Diseases Acne Vulgaris |
Facial Dermatoses Skin Diseases Acneiform Eruptions Sebaceous Gland Diseases Acne Vulgaris |