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Sponsored by: |
Stiefel Laboratories |
---|---|
Information provided by: | Stiefel Laboratories |
ClinicalTrials.gov Identifier: | NCT00807014 |
The objectives of this clinical trial are to compare the quality of life of the subjects, the efficacy and the tolerance of Duac® Gel (gel formulation with a combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide), applied once daily, against Differin® Gel (gel with 0.1% adapalene), used once daily, in the treatment of mild to moderate acne vulgaris.
Condition | Intervention | Phase |
---|---|---|
Acne Vulgaris |
Drug: Duac Gel Drug: Differin gel |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Single-Blind, Multicenter, Parallel, Comparative, Randomized, Phase IV Clinical Trial for the Clinical Evaluation of the Quality of Life of the Subject, the Efficacy and the Tolerance of Duac® Gel (Gel With Clindamycin Phosphate [Equivalent to 1% Clindamycin] and 5% Benzoyl Peroxide) Against Differin® Gel (Gel With 0.1% Adapalene) in the Topical Treatment of Mild to Moderate Acne Vulgaris. |
Enrollment: | 169 |
Study Start Date: | November 2006 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Duac Gel
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Drug: Duac Gel
Duac® Gel will be applied to the face once daily at night, for 12 weeks.
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2: Active Comparator
Differin gel
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Drug: Differin gel
Differin Gel will be applied to the face once daily at night, for 12 weeks.
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Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit. It is characterized by the formation of comedones, papules, pustules, nodules, cysts, maculae and scars, generally located on the face, chest and back. Acne pathogenesis is recognized as multifactorial.
Acne vulgaris is the most common dermatological disorder. It affects approximately 85% individuals at some point in their lives, generally between 12 and 24 years of age. Although acne is prevalent within this age range, it can persist for many years and its long-term physical and psychological implications can be significant.
There are several medicinal products used to treat acne. However, the therapeutic challenge remains, therefore it is essential to continue investigating effective strategies for the treatment of this disease.
Ages Eligible for Study: | 12 Years to 39 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
Hospital Universitario 12 de Octubre | |
Madrid, Spain, 28041 | |
Hospital Universitario Ramón and Cajal | |
Madrid, Spain, 28034 | |
Hospital Germans Trias I Pujol | |
Badalona, Spain, 08916 | |
Hospital del Mar | |
Barcelona, Spain, 08003 | |
Hospital Abente y Lago in La Coruna | |
La Coruna, Spain | |
Hospital Clínico de Salamanca | |
Salamanca, Spain, 37007 | |
Clínica Universitaria de Navarra | |
Pamplona, Spain, 31008 | |
Hospital Clínico Universitario Ntra. Sra. de the Victoria | |
Málaga, Spain, 29010 |
Study Director: | David A Angulo, MD | Sr. Director Global Clinical Research, Stiefel Laboratories, Inc. |
Principal Investigator: | Aurora Guerra Tapia, MD | Hospital Universitario 12 de Octubre |
Responsible Party: | Stiefel Laboratories, Inc ( Jason Mann, Director Global Clinical Operations ) |
Study ID Numbers: | S194-SP-05/Duac |
Study First Received: | December 10, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00807014 History of Changes |
Health Authority: | Spain: Comité Ético de Investigación Clínica |
Acne Vulgaris Acne Duac Differin quality of life |
Anti-Inflammatory Agents Clindamycin Facial Dermatoses Skin Diseases Facies Clindamycin-2-phosphate Quality of Life Benzoyl Peroxide Sebaceous Gland Diseases |
Adapalene Acne Vulgaris Exanthema Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents |
Anti-Inflammatory Agents Facial Dermatoses Skin Diseases Physiological Effects of Drugs Sebaceous Gland Diseases Adapalene Acne Vulgaris Pharmacologic Actions Acneiform Eruptions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Dermatologic Agents |