Overview

A Clinical Study to Evaluate the Tolerability of a Topical Antibiotic and Retinoid Used in a Combined Regimen With a BPO Wash

Status:
Completed
Trial end date:
2009-06-05
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the tolerability of a combined regimen of a topical antibiotic and retinoid and a benzoyl peroxide wash.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Stiefel, a GSK Company
Collaborator:
GlaxoSmithKline
Treatments:
Anti-Bacterial Agents
Benzoyl Peroxide
Clindamycin, tretinoin drug combination
Criteria
Inclusion Criteria:

- Subjects with mild to moderate facial acne vulgaris, with no history of known or
suspected hypersensitivity or previous allergic reaction to any of the ingredients of
the study products (eg, topical antibiotics, retinoids or benzoyl peroxide), capable
of understanding and willing to provide signed and dated written voluntary informed
consent and able to complete the study and to comply with study instructions.

- Female subjects of childbearing potential must have a negative urine pregnancy test
result at baseline and practice a reliable method of contraception throughout the
study.

Exclusion Criteria:

- Use of topical antibiotics on the face within the past 2 weeks or use of systemic
antibiotics within the past 4 weeks.