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Sponsored by: |
Galderma |
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Information provided by: | Galderma |
ClinicalTrials.gov Identifier: | NCT00446043 |
This is a multi-centre, open-label, non-comparative study to evaluate the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel.
Subjects are evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12.
Safety is evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing (haematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations. Efficacy is evaluated by analysis of Percent Change from Baseline in Inflammatory, Noninflammatory, and Total Lesion Counts, and by the Subject’s Assessment of Acne.
Condition | Intervention | Phase |
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Acne Vulgaris |
Drug: Adapalene/Benzoyl Peroxide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Long-Term Safety and Efficacy Study of a Fixed Combination of Adapalene 0.1% and Benzoyl Peroxide 2.5% (Adapalene and Benzoyl Peroxide Topical Gel) Gel in Subjects With Acne Vulgaris |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | RD.06.SPR.18089 |
Study First Received: | March 8, 2007 |
Last Updated: | March 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00446043 |
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 |