Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01773122
First received: January 18, 2013
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Acne Vulgaris
Drug: Dapsone Formulation A
Drug: Dapsone Formulation B
Drug: Dapsone Formulation C
Drug: Dapsone 5% Gel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Maximum Plasma Level (Cmax) of Dapsone [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended.


Secondary Outcome Measures:
  • Maximum Plasma Level (Cmax) of Dapsone Metabolites [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended. The dapsone metabolites are N-acetyl dapsone and dapsone hydroxylamine.


Enrollment: 77
Study Start Date: January 2013
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dapsone Formulation A
Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Drug: Dapsone Formulation A
Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Experimental: Dapsone Formulation B
Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Drug: Dapsone Formulation B
Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Experimental: Dapsone Formulation C
Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Drug: Dapsone Formulation C
Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Active Comparator: Dapsone 5% Gel
Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
Drug: Dapsone 5% Gel
Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
Other Name: ACZONE®

  Eligibility

Ages Eligible for Study:   16 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773122

Locations
United States, Texas
College Station, Texas, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01773122     History of Changes
Other Study ID Numbers: 225678-004
Study First Received: January 18, 2013
Results First Received: February 11, 2014
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Dapsone
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 17, 2014