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Sponsored by: |
Stiefel Laboratories |
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Information provided by: | Stiefel Laboratories |
ClinicalTrials.gov Identifier: | NCT00887484 |
The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.
Condition | Intervention | Phase |
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Acne Vulgaris |
Drug: BENZOYL PEROXIDE/ CLINDAMYCIN Drug: BENZOYL PEROXIDE/ ADAPALENE |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Single-Blind, Randomized, Comparative Pilot Study Evaluating the Tolerability of Two Topical Combination Therapies in the Treatment of Acne Vulgaris |
Estimated Enrollment: | 45 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Subject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening.
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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.
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2: Active Comparator
Subject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening.
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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.
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The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Argentina, Buenos Aires | |
Hospital Italiano de Buenos Aires | Recruiting |
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1181 ACH | |
Contact: Pablo Tesolin, MD (5411) 4959 0200 pablo.tesolin@hospitalitaliano.org.ar | |
Principal Investigator: Pablo D Tesolin, MD | |
Buenos Aires Skin | Recruiting |
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1055AAO | |
Contact: Pablo J. Gonzalez, MD (5411) 5219 0541/42/43 gonzalezp@gmail.com | |
Principal Investigator: Pablo J. Gonzalez, MD | |
LUMIPIEL - Centro Dermatológico | Recruiting |
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1181 ACH | |
Contact: Eduardo A Rodriguez, MD (5411) 4821 1020 dreduardorodriguez@fhertel.com.ar | |
Principal Investigator: Eduardo A. Rodriguez, MD | |
Centro de Investigación y Prevencion de Enfermidades Cardiovasculares | Recruiting |
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1119 | |
Contact: Tania Zarowsky, MD (5411) 4827 3866 taniazaro@hotmail.com | |
Principal Investigator: Tania Zarowsky, MD |
Study Director: | Marcela Cirigliano, MD | Stiefel Laboratories, Inc |
Responsible Party: | Stiefel Laboratories, Inc. ( Jason Mann/Director, Global Clinical Operations ) |
Study ID Numbers: | C0000-401 |
Study First Received: | April 23, 2009 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00887484 History of Changes |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Acne Vulgaris Acne |
Anti-Bacterial Agents Exanthema Clindamycin Facial Dermatoses Clindamycin-2-phosphate Facies |
Skin Diseases Benzoyl Peroxide Adapalene Sebaceous Gland Diseases Acne Vulgaris |
Anti-Infective Agents Clindamycin Facial Dermatoses Molecular Mechanisms of Pharmacological Action Skin Diseases Clindamycin-2-phosphate Benzoyl Peroxide Enzyme Inhibitors |
Sebaceous Gland Diseases Acne Vulgaris Pharmacologic Actions Anti-Bacterial Agents Protein Synthesis Inhibitors Acneiform Eruptions Therapeutic Uses Dermatologic Agents |