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| Sponsor: | Galderma |
|---|---|
| Information provided by: | Galderma |
| ClinicalTrials.gov Identifier: | NCT00688064 |
Purpose
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.
| Condition | Intervention | Phase |
|---|---|---|
|
Severe Acne Vulgaris |
Drug: Adapalene BPO Gel associated with Doxycyline Hyclate Drug: Vehicle Gel associated with Doxycycline Hyclate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Associated With Doxycycline Hyclate 100 mg Tablets Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Vehicle Gel Associated With Doxycycline Hyclate 100 mg Tablets in the Treatment of Severe Acne Vulgaris. |
| Enrollment: | 459 |
| Study Start Date: | August 2008 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
|
Drug: Adapalene BPO Gel associated with Doxycyline Hyclate
Adapalene BPO Gel: Topical to the face, once daily in the evening Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
|
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2: Active Comparator
Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
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Drug: Vehicle Gel associated with Doxycycline Hyclate
Vehicle Gel: Topical to the face, once daily in the evening; Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
|
Further to this study, eligible Subjects with at least good Global Assessment of Improvement at Week 12 will be randomized in a maintenance study (SPR.29075)
Eligibility| Ages Eligible for Study: | 12 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 34 Study Locations| Principal Investigator: | Linda Stein Gold, MD | Henry Ford Medical Center-New Center One, Detroit, MI |
More Information
| Responsible Party: | Galderma ( Jean-Charles DHUIN Clinical Trial Manager ) |
| Study ID Numbers: | RD.03.SPR.29074 |
| Study First Received: | May 28, 2008 |
| Last Updated: | January 29, 2010 |
| ClinicalTrials.gov Identifier: | NCT00688064 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; Canada: Health Canada; Canada: Ethics Review Committee |
|
Acne |
|
Anti-Inflammatory Agents Anti-Infective Agents Antiprotozoal Agents Facial Dermatoses Physiological Effects of Drugs Benzoyl Peroxide Adapalene Sebaceous Gland Diseases Acne Vulgaris Anti-Bacterial Agents Antimalarials Antiparasitic Agents Acneiform Eruptions |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Dermatologic Agents Skin Diseases Pharmacologic Actions Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Doxycycline |