Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris

April 11, 2019 updated by: Allergan
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of dapsone in subjects with acne vulgaris following 28 days of dosing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 35 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • ACZONE®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 21, 2013

Primary Completion (ACTUAL)

May 5, 2013

Study Completion (ACTUAL)

May 5, 2013

Study Registration Dates

First Submitted

January 18, 2013

First Submitted That Met QC Criteria

January 18, 2013

First Posted (ESTIMATE)

January 23, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 24, 2019

Last Update Submitted That Met QC Criteria

April 11, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 225678-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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