Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne

Condition(s) targeted: Acne Vulgaris

Intervention: Fixed Combination dapsone/adapalene Formulation A Gel (Drug); Fixed Combination dapsone/adapalene Formulation B Gel (Drug); dapsone 5% gel (Drug); adapalene 0.3% gel (Drug)

Phase: Phase 1

Status: Withdrawn

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan

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.

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Primary outcome:

Plasma Levels of Dapsone

Plasma Levels of Dapsone

Plasma Levels of Adapalene

Plasma Levels of Adapalene

Secondary outcome: Local Dermal Tolerability Rating Using a 4-Point Scale

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

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

Starting date: January 2013
Last updated: November 16, 2012