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Completed

NCT Number: NCT01773122

Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris

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

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

16 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

College Station, Texas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapsone Formulation A

Drug

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

Dapsone Formulation B

Drug

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

Dapsone Formulation C

Drug

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

Dapsone 5% Gel

Drug

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

Other names: ACZONE®

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 23, 2013
Registry last updated
Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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