search
Back to results

Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dapsone Formulation A
Dapsone Formulation B
Dapsone Formulation C
Dapsone 5% Gel
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acne Vulgaris

Eligibility Criteria

16 Years - 35 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Dapsone Formulation A

Dapsone Formulation B

Dapsone Formulation C

Dapsone 5% Gel

Arm Description

Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.

Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.

Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.

Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.

Outcomes

Primary Outcome Measures

Maximum Plasma Level (Cmax) of Dapsone
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
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.

Full Information

First Posted
January 18, 2013
Last Updated
April 11, 2019
Sponsor
Allergan
search

1. Study Identification

Unique Protocol Identification Number
NCT01773122
Brief Title
Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 21, 2013 (Actual)
Primary Completion Date
May 5, 2013 (Actual)
Study Completion Date
May 5, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dapsone Formulation A
Arm Type
Experimental
Arm Description
Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Arm Title
Dapsone Formulation B
Arm Type
Experimental
Arm Description
Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Arm Title
Dapsone Formulation C
Arm Type
Experimental
Arm Description
Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Arm Title
Dapsone 5% Gel
Arm Type
Active Comparator
Arm Description
Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
Intervention Type
Drug
Intervention Name(s)
Dapsone Formulation A
Intervention Description
Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Intervention Type
Drug
Intervention Name(s)
Dapsone Formulation B
Intervention Description
Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Intervention Type
Drug
Intervention Name(s)
Dapsone Formulation C
Intervention Description
Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
Intervention Type
Drug
Intervention Name(s)
Dapsone 5% Gel
Other Intervention Name(s)
ACZONE®
Intervention Description
Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
Primary Outcome Measure Information:
Title
Maximum Plasma Level (Cmax) of Dapsone
Description
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.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Maximum Plasma Level (Cmax) of Dapsone Metabolites
Description
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.
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
College Station
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27741344
Citation
Jarratt MT, Jones TM, Chang-Lin JE, Tong W, Berk DR, Lin V, Kaoukhov A. Safety and Pharmacokinetics of Once-Daily Dapsone Gel, 7.5% in Patients With Moderate Acne Vulgaris. J Drugs Dermatol. 2016 Oct 1;15(10):1250-1259.
Results Reference
background

Learn more about this trial

Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris

We'll reach out to this number within 24 hrs