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Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01773122
First Posted: January 23, 2013
Last Update Posted: March 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773122


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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01773122     History of Changes
Other Study ID Numbers: 225678-004
First Submitted: January 18, 2013
First Posted: January 23, 2013
Results First Submitted: February 11, 2014
Results First Posted: March 26, 2014
Last Update Posted: March 26, 2014
Last Verified: February 2014

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