Pharmacokinetics Study of Dapsone-Adapalene Fixed Combination Gel in Acne

Allergan

Status and phase: Withdrawn; Phase 1

Conditions: Acne Vulgaris

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01425320

225678-003

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 4 patient groups

Fixed Combination dapsone/adapalene Formulation A Gel

Experimental group

Description:

Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.

Treatment:

Drug: Fixed Combination dapsone/adapalene Formulation A Gel

Fixed Combination dapsone/adapalene Formulation B Gel

Experimental group

Description:

Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.

Treatment:

Drug: Fixed Combination dapsone/adapalene Formulation B Gel

dapsone 5% gel (ACZONE®)

Active Comparator group

Description:

Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders.

Treatment:

Drug: dapsone 5% gel

adapalene 0.3% gel (Differin®)

Active Comparator group

Description:

Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.

Treatment:

Drug: adapalene 0.3% gel