Skip to main content
OpenTrials
Completed

NCT Number: NCT00249782

A Phase II, Randomized Study of ACZONE™ (Dapsone) Gel, 5% for Papulopustular Rosacea.

The purpose of this study is to evaluate the safety and effectiveness of ACZONE™ gel compared to placebo (inactive substance), MetroGel® and a combination of ACZONE™ gel and MetroGel® for the treatment of rosacea.

ACZONE™ gel, 5% is a topical (applied to the skin) medication that is approved by the United States Food and Drug Administration (FDA) for the treatment of acne vulgaris in people 12 years and older. The use of ACZONE™ for the treatment of rosacea is investigational. An investigational use is one that is not approved by the FDA.

Subjects will apply the study treatment for 12 weeks. Efficacy assessments will be performed at baseline and Weeks 2, 4, 8, and 12. Laboratory assessments will be conducted at baseline and Week, 2, 4 and 12.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rosacea Erythema Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Radiant Research, Birmingham, Alabama, United States

Loading trial locations.

About this study

Study Objective:

•To evaluate the safety and preliminary efficacy of ACZONE in subjects with papulopustular rosacea

Study Population: Approximately 400 male and female subjects will be enrolled at 27 study centers in the United States.

Study Treatment: Subjects will be randomized to 1 of 5 treatment regimens. Subjects will receive study medication for 12 weeks. Study participation is 13 weeks (5 clinic visits and 1 telephone follow-up).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

To be eligible for the study, subjects must fulfill all of the following criteria:

  • Men or women ≥18 years of age.
  • A diagnosis of papulopustular rosacea, with ≥10 inflammatory lesions (papules and/or pustules) above the mandibular line at baseline.
  • An Investigator Global Assessment (IGA) score ≥2
  • In good physical and mental health.
  • Signature of an approved informed consent form for the study and HIPAA authorization (if applicable).
  • Willingness to comply with the protocol.

Exclusion criteria

Subjects meeting any of the following criteria will be excluded from the study:

  • A skin examination reveals the presence of another skin disease and/or condition (excessive facial hair, excessive scarring, sunburn, or other disfigurement) located on the face that would confound the evaluation of the rosacea condition.
  • Current or past ocular rosacea, such as conjunctivitis, iritis, and keratitis, of sufficient severity to require topical or systemic antibiotics.
  • Treatment with topical antibiotics, topical steroids and other topical rosacea treatments on the face within 14 days of Baseline and throughout the study.
  • Treatment with systemic steroids within 30 days of Baseline and throughout the study.
  • Treatment with any systemic antibiotics within 30 days of Baseline and throughout the study.
  • Treatment with any systemic medication or therapy known to affect inflammatory responses within the 30 days prior to Baseline or throughout the study.
  • Treatment with topical retinoids within 30 days or systemic retinoids within 180 days of Baseline and throughout the study.
  • Treatment with physical modalities that could benefit rosacea are prohibited within 30 days of Baseline and throughout the study.

Treatment and study plan

Vehicle control, 2x/day

Drug

ACZONE (dapsone) Gel, 5%, 2x/day

Drug

ACZONE (dapsone) Gel, 5%, 1x/day

Drug

MetroGel® (metronidazole gel), 1.0% 1x/day

Drug

ACZONE (dapsone) Gel, 5%, 1x/day (AM) + MetroGel (metronidazole gel), 1.0%, 1x/day (PM)

Drug

Primary outcomes

  1. Efficacy: Percent change and change from baseline in inflammatory lesion counts;

  2. "Success" rate, defined as proportion of subjects with a score of 0 or 1 and at least a 2 point improvement from baseline on the IGA scale;

  3. Erythema & telangiectasia scores;

  4. Lesion counts over time

Secondary outcomes

  1. Safety: Adverse events and concomitant medications; Local symptom scores; Hematology and chemistry laboratory parameters; Vital signs

  2. Other: Plasma dapsone concentrations

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

A Phase II, Randomized, Partial-Blind, Parallel-Group, Active- and Vehicle-Controlled, Multicenter Study of the Safety and Efficacy of ACZONE™ (Dapsone) Gel, 5% in Subjects With Papulopustular Rosacea

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Nov 7, 2005
Registry last updated
May 30, 2011

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.