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| Sponsored by: |
Galderma Laboratories, L.P. |
| Information provided by: | Galderma Laboratories, L.P. |
| ClinicalTrials.gov Identifier: | NCT00671749 |
Purpose
This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.
| Condition | Intervention | Phase |
|
Acne Vulgaris |
Drug: adapalene gel, 0.3% Drug: clindamycin/benzoyl peroxide gel |
Phase IV |
| MedlinePlus related topics: | Acne |
| ChemIDplus related topics: | Benzoyl peroxide Clindamycin Clindamycin hydrochloride Clindamycin palmitate Clindamycin Palmitate Hydrochloride Clindamycin phosphate Adapalene |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris |
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | May 2008 |
| Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Same as above.
Eligibility
| Ages Eligible for Study: | 12 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
1. Subjects with more than three nodulo-cystic lesions
Contacts and Locations| Contact: Luz E Colon, MS | 817-961-5243 | lucy.colon@galderma.com |
| United States, California | |||||
| Center for Dermatology and Laser Surgery | Recruiting | ||||
| Sacramento, California, United States, 95819 | |||||
| Contact: Regan Johnson 916-454-5922 dictationet@mgci.com | |||||
| Principal Investigator: Emil A Tanghetti, MD | |||||
| United States, Kentucky | |||||
| Derm Research, P.L.L.C. | Completed | ||||
| Louisville, Kentucky, United States, 40217 | |||||
| United States, Ohio | |||||
| Brodell Medical | Recruiting | ||||
| Warren, Ohio, United States, 44483 | |||||
| Contact: Sandra Treleven 330-393-4000 Sltreleven@aol.com | |||||
| Principal Investigator: Robert T Brodell, MD | |||||
| United States, Oregon | |||||
| Northwest Cutaneous Research Specialists | Recruiting | ||||
| Portland, Oregon, United States, 97210 | |||||
| Contact: Kristen Reid 503-226-3376 reidkri@gmail.com | |||||
| Principal Investigator: Phoebe Rich, MD | |||||
| Galderma Laboratories, L.P. |
| Study Director: | Ron W Gottschalk, MD | Galderma Laboratories, L.P. |
More Information
| Responsible Party: | Galderma Laboratories, L.P. ( Ronald W. Gottschalk, MD / Medical Director ) |
| Study ID Numbers: | US10066 |
| First Received: | April 30, 2008 |
| Last Updated: | April 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00671749 |
| Health Authority: | United States: Institutional Review Board |
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