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| Sponsor: | Stiefel, a GSK Company |
|---|---|
| Information provided by: | Stiefel, a GSK Company |
| ClinicalTrials.gov Identifier: | NCT00887484 |
Purpose
The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Drug: BENZOYL PEROXIDE/ CLINDAMYCIN Drug: BENZOYL PEROXIDE/ ADAPALENE |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | A Single-blind, Randomized, Comparative Pilot Study Evaluating the Tolerability of Two Topical Combination Therapies in the Treatment of Acne Vulgaris |
| Enrollment: | 50 |
| Study Start Date: | February 2009 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Subject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening.
|
Drug: BENZOYL PEROXIDE/ CLINDAMYCIN
Commencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks.
|
|
Active Comparator: 2
Subject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening.
|
Drug: BENZOYL PEROXIDE/ ADAPALENE
Commencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks.
|
The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Argentina | |
| Hospital Italiano de Buenos Aires | |
| Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1181 ACH | |
| LUMIPIEL - Centro Dermatológico | |
| Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1181 ACH | |
| Centro de Investigación y Prevencion de Enfermidades Cardiovasculares | |
| Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1119 | |
| Buenos Aires Skin | |
| Ciudad de Buenos Aires, Buenos Aires, Argentina, C1055AAO | |
| Study Director: | Marcela Cirigliano, MD | Stiefel Laboratories, Inc |
More Information
| Responsible Party: | Jason Mann/Director, Global Clinical Operations, Stiefel Laboratories, Inc. |
| ClinicalTrials.gov Identifier: | NCT00887484 History of Changes |
| Other Study ID Numbers: | C0000-401 |
| Study First Received: | April 23, 2009 |
| Last Updated: | December 22, 2009 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
|
Acne Vulgaris Acne |
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases Adapalene Benzoyl Peroxide Clindamycin Clindamycin-2-phosphate Dermatologic Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents Anti-Infective Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Central Nervous System Agents |