Status:
COMPLETED
Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne
Lead Sponsor:
Stiefel, a GSK Company
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12-45 years
Phase:
PHASE2
Brief Summary
Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product ...
Detailed Description
The study subjects must have acne vulgaris and will apply study drug to their face for 12 weeks. Study visits will occur at baseline (day 1) and at weeks 2, 4, 8, and 12. Subjects will be assessed at...
Eligibility Criteria
Inclusion
- Subjects must be males or females 12 to 45 years of age.
- Subjects must have acne on their face.
- Female subjects of childbearing potential must have a negative pregnancy test. If sexually active, one medically acceptable forms of contraception must be practiced from baseline to the last study visit.
- Subjects must have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
- Subjects must be capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements).
- Subjects must be able to complete the study and to comply with study instructions.
Exclusion
- Subjects who are pregnant, trying to become pregnant, or breast-feeding.
- Subjects with conditions that may influence the safety and or efficacy assessments of the study including, but not limited to: regional enteritis or inflammatory bowel disease, lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis, or perioral dermatitis, subject who are immunocompromised or have had any major illness within 30 days before the screening examination
- History of known or suspected intolerance including any known hypersensitivity or previous allergic reaction to any of the ingredients of the study products
- Subjects who have used topical antibiotics or topical steroids on the face, facial procedures, or any investigational therapy within the past 4 weeks or systemic retinoids within the past 6 months.
- Subjects who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put the subject at unacceptable risk for participation in the study.
- Other exclusion criteria may apply.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
591 Patients enrolled
Trial Details
Trial ID
NCT00713609
Start Date
June 1 2008
End Date
March 1 2009
Last Update
March 6 2017
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Dermatology Research of Arkansas
Little Rock, Arkansas, United States, 72205
2
Center for Dermatology Cosmetic and Laser Surgery
Fremont, California, United States, 94538
3
Center for Dermatology and Laser Surgery
Sacramento, California, United States, 95819
4
Boulder Medical Center, P.C.
Boulder, Colorado, United States, 80304