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Sponsored by: |
Galderma |
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Information provided by: | Galderma |
ClinicalTrials.gov Identifier: | NCT00421993 |
This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study.
The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks.
Condition | Intervention | Phase |
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Acne Vulgaris |
Drug: Adapalene/Benzoyl Peroxide Drug: Adapalene Drug: Benzoyl Peroxide Drug: Topical Gel Vehicle |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris |
Enrollment: | 1670 |
Study Start Date: | October 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Adapalene/Benzoyl Peroxide Topical Gel
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Drug: Adapalene/Benzoyl Peroxide
Topical Gel, One application daily in the evening for 12 weeks
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2: Active Comparator
Adapalene Topical Gel
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Drug: Adapalene
Topical Gel,One application daily in the evening for 12 weeks
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3: Active Comparator
Benzoyl Peroxide Topical Gel
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Drug: Benzoyl Peroxide
Topical Gel, one application daily in the evening for 12 weeks
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4: Placebo Comparator
Topical Gel Vehicle
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Drug: Topical Gel Vehicle
Topical Gel Vehicle,one application daily in the evening for 12 weeks
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Michael Graeber, MD | Galderma |
Responsible Party: | Galderma ( Michael Graeber, MD, Head of US Development ) |
Study ID Numbers: | RD.06.SPR.18088 |
Study First Received: | January 11, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00421993 |
Health Authority: | United States: Food and Drug Administration |
Acne vulgaris Adapalene Benzoyl Peroxide |
Exanthema Facial Dermatoses Facies Skin Diseases |
Benzoyl Peroxide Adapalene Sebaceous Gland Diseases Acne Vulgaris |
Anti-Inflammatory Agents Physiological Effects of Drugs Pharmacologic Actions Acneiform Eruptions Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses |
Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Dermatologic Agents Central Nervous System Agents |