NCT01773122

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

January 21, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2013

Completed
11 months until next milestone

Results Posted

Study results publicly available

March 26, 2014

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

January 18, 2013

Results QC Date

February 11, 2014

Last Update Submit

April 11, 2019

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 28

Secondary Outcomes (1)

  • Maximum Plasma Level (Cmax) of Dapsone Metabolites

    Day 28

Study Arms (4)

Dapsone Formulation A

EXPERIMENTAL

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

Drug: Dapsone Formulation A

Dapsone Formulation B

EXPERIMENTAL

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

Drug: Dapsone Formulation B

Dapsone Formulation C

EXPERIMENTAL

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

Drug: Dapsone Formulation C

Dapsone 5% Gel

ACTIVE COMPARATOR

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

Drug: Dapsone 5% Gel

Interventions

Dapsone Formulation ADRUG

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

Dapsone Formulation A
Dapsone Formulation BDRUG

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

Dapsone Formulation B
Dapsone Formulation CDRUG

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

Dapsone Formulation C
Dapsone 5% GelDRUG

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

Also known as: ACZONE®
Dapsone 5% Gel

Eligibility Criteria

Age16 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Oral acne treatments within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

College Station, Texas, United States

Location

Related Publications (1)

  • 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.

    PMID: 27741344BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Interventions

DapsoneGels

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Results Point of Contact

Title
Therapeutic Area Head,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2013

First Posted

January 23, 2013

Study Start

January 21, 2013

Primary Completion

May 5, 2013

Study Completion

May 5, 2013

Last Updated

April 24, 2019

Results First Posted

March 26, 2014

Record last verified: 2019-04

Locations

US(1)