Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:January 2013
End Date:June 2013
Contact:Allergan Inc.
Email:clinicaltrials@allergan.com

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This study will investigate the pharmacokinetics, safety and tolerability of dapsone and
adapalene following topical administration of 2 formulations of dapsone/adapalene fixed
combination gel, dapsone 5% gel (ACZONE®), and adapalene 0.3% gel (Differin®) in subjects
with acne vulgaris.


Inclusion Criteria:

- Moderate acne on the face

- Willing to avoid swimming during the study

- Willing to avoid excessive sunlight and ultraviolet light (e.g., tanning beds)during
the study

- Willing to avoid moisturizers, sunscreens, cosmetics, and chemical peels during the
study

Exclusion Criteria:

- Severe cystic acne

- Use of topical or oral retinoids within 4 weeks

- Use of isotretinoin within 3 months

- Use of dapsone or adapalene within 3 months

- Anticipated need to engage in activities/exercise that would cause profuse sweating

- Donated blood or equivalent blood loss within 90 days
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