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Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris

NCT01773122 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2019-04-24

Study results available
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Summary

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

Conditions

  • Acne Vulgaris

Interventions

DRUG

Dapsone Formulation A

Dapsone Formulation A 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.

DRUG

Dapsone Formulation C

Dapsone Formulation C applied once 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.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-21
Primary Completion
2013-05-05
Completion
2013-05-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01773122 on ClinicalTrials.gov