Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris

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Allergan

Status and phase

Completed
Phase 1

Conditions

Acne Vulgaris

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01773122
225678-004

Details and patient eligibility

About

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of dapsone in subjects with acne vulgaris following 28 days of dosing.

Enrollment

77 patients

Sex

All

Ages

16 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of acne vulgaris
  • Willing to avoid excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) throughout the study
  • If male, the subject must agree to shave the facial treatment area and agree to maintain his routine shaving regimen for the duration of the study
  • willing to avoid applying moisturizers, sunscreens, cosmetics (except eye and lip makeup), and chemical peels throughout the study

Exclusion criteria

  • Oral acne treatments within 6 months

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

77 participants in 4 patient groups

Dapsone Formulation A
Experimental group
Description:
Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Treatment:
Drug: Dapsone Formulation A
Dapsone Formulation B
Experimental group
Description:
Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Treatment:
Drug: Dapsone Formulation B
Dapsone Formulation C
Experimental group
Description:
Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Treatment:
Drug: Dapsone Formulation C
Dapsone 5% Gel
Active Comparator group
Description:
Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
Treatment:
Drug: Dapsone 5% Gel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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