A Comparative Study of the Tolerability of Two Combination Therapies for the Treatment of Acne

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stiefel, a GSK Company
• Collaborator: GlaxoSmithKline
• Treatments: Adapalene; Benzoyl Peroxide; Clindamycin; Clindamycin palmitate; Clindamycin phosphate

Criteria

Inclusion Criteria:

• Male or female subjects at least 21 years of age, in good general health with documented diagnosis of acne vulgaris.

• Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception Abstinence is considered an acceptable method of contraception.

• Inflammatory (papules and pustules) and non-inflammatory (open and closed comedones) facial lesions.

• The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study

• Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed

Exclusion Criteria:

• Female subjects who are pregnant, trying to become pregnant or breastfeeding.

• Subjects who have any clinically relevant finding at their baseline physical other than acne vulgaris.

• History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.

• Use of topical antibiotics or anti-acne medications 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.

• Facial procedures performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks or during the conduct of the study.

• Known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, adapalene, clindamycin, benzoyl peroxide or excipients of the study product.