Acne Vulgaris
Conditions
Brief summary
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.
Interventions
DRUGFixed Combination dapsone/adapalene Formulation A Gel
Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
DRUGFixed Combination dapsone/adapalene Formulation B Gel
Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
DRUGdapsone 5% gel
Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders.
DRUGadapalene 0.3% gel
Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma Levels of Dapsone | Day 1 |
| Plasma Levels of Adapalene | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Local Dermal Tolerability Rating Using a 4-Point Scale | Day 14 |
Outcome results
None listed