An Extension Study to Assess the Safety, Tolerability, Efficacy, and Treatment Adherence of Dapsone in Acne Vulgaris

Allergan

Status and phase: Withdrawn; Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: Dapsone 5% Gel; Drug: Dapsone Formulation A; Drug: Dapsone Formulation C; Drug: Dapsone Formulation B

Study type: Interventional

Funder types: Industry

Identifiers

NCT01785836

225678-005

Details and patient eligibility

About

This study will assess the safety, tolerability, and efficacy of dapsone in subjects with acne vulgaris following 12 weeks of treatment.

Sex: All

Ages: 12 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participation in Allergan study 225678-004

Exclusion criteria

• Anticipates the need for surgery or hospitalization during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 4 patient groups

Dapsone Formulation A

Experimental group

Description:

Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Treatment:

Drug: Dapsone Formulation A

Dapsone Formulation B

Experimental group

Description:

Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Treatment:

Drug: Dapsone Formulation B

Dapsone Formulation C

Experimental group

Description:

Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Treatment:

Drug: Dapsone Formulation C

Dapsone 5% Gel

Active Comparator group

Description:

Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Treatment:

Drug: Dapsone 5% Gel