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Sponsored by: |
Galderma |
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Information provided by: | Galderma |
ClinicalTrials.gov Identifier: | NCT00598832 |
The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.
Condition | Intervention | Phase |
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Acne Vulgaris |
Drug: Adapalene Drug: Vehicle |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Enrollment: | 1075 |
Study Start Date: | November 2007 |
Study Completion Date: | November 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: Adapalene
Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
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B: Placebo Comparator |
Drug: Vehicle
Vehicle will be applied topically to the face, once a day, for 12 weeks
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This study will compare the efficacy and safety of Adapalene, 0.1% and vehicle in the treatment of subjects with Acne Vulgaris. This is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria.
Male and female subjects, 12 years of age or older, with 20-50 papules and pustules and 30 to 100 non-inflammatory lesions and have an Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe) are eligible for enrollment. One nodule may be present at inclusion. Acne lesions are evaluated on the face only. Subjects presenting with facial and truncal acne vulgaris can participate in this study. Subjects will be randomized in a 1:1 ratio to Adapalene, 0.1% or Vehicle.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Dow Pharmaceutical Sciences, Inc. ( Barry M. Calvarese, Vice President Regulatory and Clinical Affairs ) |
Study ID Numbers: | RD.06.SPR.18113, IND 076057 |
Study First Received: | January 11, 2008 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00598832 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Acne Vulgaris Adapalene |
Anti-Inflammatory Agents Facial Dermatoses Skin Diseases Facies Sebaceous Gland Diseases Adapalene Acne Vulgaris |
Exanthema Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents 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 |