Status:
COMPLETED
A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne
Lead Sponsor:
Stiefel, a GSK Company
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Acne Vulgaris
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxid...
Detailed Description
Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks and consists of a baseline visit and visits at weeks 1, 2, 5 and 8. Commencing at baseline, ...
Eligibility Criteria
Inclusion
- Male or female subjects at least 18 years of age, in good general health with documented diagnosis of facial acne vulgaris.
- Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
- Subjects willing to follow therapeutic instructions including avoidance of any other topical facial or systemic acne therapy during the conduct of the study.
- Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.
Exclusion
- Female subjects who are pregnant, trying to become pregnant or breastfeeding.
- Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases, diseases of the facial skin, other than acne vulgaris.
- Facial hair that may obscure the accurate assessment of acne grade.
- History or presence of regional enteritis or inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
- Use of topical antibiotics on the face and systemic antibiotics within the past 2 and 4 weeks, respectively.
- Use of topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
- Use of systemic retinoids within the past 6 months.
- Concurrent use of drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.
- Concomitant use of neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
- Use of topical anti-acne medications within the past 2 weeks.
- Use of any investigational drugs or treatments during the study or within 4 weeks of the baseline visit.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00964223
Start Date
July 1 2009
End Date
November 1 2009
Last Update
November 23 2016
Active Locations (2)
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1
Aesthetics, Skin Care & Dermasurgery
Rockville, Maryland, United States, 20850
2
Grekin Skin Institute
Warren, Michigan, United States, 48088