Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne

Study Overview
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Brief Summary
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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.

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Fixed Combination dapsone/adapalene Formulation A Gel
* Drug: Fixed Combination dapsone/adapalene Formulation B Gel
* Drug: dapsone 5% gel
* Drug: adapalene 0.3% gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fixed Combination dapsone/adapalene Formulation A Gel<br>Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders. | Drug: Fixed Combination dapsone/adapalene Formulation A Gel<br>* Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.<br>|
| Experimental: Fixed Combination dapsone/adapalene Formulation B Gel<br>Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders. | Drug: Fixed Combination dapsone/adapalene Formulation B Gel<br>* Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.<br>|
| Active Comparator: dapsone 5% gel (ACZONE®)<br>Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders. | Drug: dapsone 5% gel<br>* Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders.<br>* Other names: ACZONE®;|
| Active Comparator: adapalene 0.3% gel (Differin®)<br>Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders. | Drug: adapalene 0.3% gel<br>* Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.<br>* Other names: Differin®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Levels of Dapsone |  | Day 1 | 
| Plasma Levels of Dapsone |  | Day 14 | 
| Plasma Levels of Adapalene |  | Day 1 | 
| Plasma Levels of Adapalene |  | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Dermal Tolerability Rating Using a 4-Point Scale |  | Day 14 |