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

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

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.

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: 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)

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Radiant Research
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Radiant Research
  • California
    • Fremont, California, United States, 94538
      • East Bay Dermatology Medical Group, Inc.
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
    • Santa Monica, California, United States, 90404
      • Clincial Research Specialists, Inc.
  • Colorado
    • Denver, Colorado, United States, 80246
      • Cherry Creek Research, Inc
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • The Savin Center, PC
  • Florida
    • Boynton Beach, Florida, United States, 33437
      • Visions Clinical Research
    • Clearwater, Florida, United States, 33761
      • Tampa Bay Medical Research
    • Miami, Florida, United States, 33175
      • FXM Research
    • Pembroke Pines, Florida, United States, 33024
      • University Clinical Research, Inc.
  • Georgia
    • Newnan, Georgia, United States, 30263
      • MedaPhase, Inc.
  • Indiana
    • Evansville, Indiana, United States, 478713
      • Welborn Clinic
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Dermatology Clinical Trials Unit Washington University
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology Associates
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University Dermatology Consultants, Inc.
    • Cincinnati, Ohio, United States, 45230
      • Dermatology Research Associates Inc.
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center
    • Portland, Oregon, United States, 97210
      • Northwest Dermatology and Research Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Co., Inc.
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Dermatology Research Association, Inc.
  • Texas
    • Austin, Texas, United States, 78759
      • Dermresearch, Inc.
    • Bryan, Texas, United States, 77802
      • J&S Studies Inc.
  • Wisconsin
    • Madison, Wisconsin, United States, 53719
      • Madison Skin & Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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

Exclusion Criteria:

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

1. 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.
2. Current or past ocular rosacea, such as conjunctivitis, iritis, and keratitis, of sufficient severity to require topical or systemic antibiotics.
3. Treatment with topical antibiotics, topical steroids and other topical rosacea treatments on the face within 14 days of Baseline and throughout the study.
4. Treatment with systemic steroids within 30 days of Baseline and throughout the study.
5. Treatment with any systemic antibiotics within 30 days of Baseline and throughout the study.
6. Treatment with any systemic medication or therapy known to affect inflammatory responses within the 30 days prior to Baseline or throughout the study.
7. Treatment with topical retinoids within 30 days or systemic retinoids within 180 days of Baseline and throughout the study.
8. Treatment with physical modalities that could benefit rosacea are prohibited within 30 days of Baseline and throughout the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy: Percent change and change from baseline in inflammatory lesion counts;
"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;
Erythema & telangiectasia scores;
Lesion counts over time

Secondary Outcome Measures

Outcome Measure
Safety: Adverse events and concomitant medications; Local symptom scores; Hematology and chemistry laboratory parameters; Vital signs
Other: Plasma dapsone concentrations

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Steven Garrett, MS, DDS, QLT USA, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): May 1, 2006
• Study Completion (Actual): May 1, 2006

Study Registration Dates

• First Submitted: November 3, 2005
• First Submitted That Met QC Criteria: November 3, 2005
• First Posted (Estimate): November 7, 2005

Study Record Updates

• Last Update Posted (Estimate): May 30, 2011
• Last Update Submitted That Met QC Criteria: May 27, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: rosacea, Papulopustular Rosacea,erythema, dapsone
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Metronidazole; Dapsone
• Other Study ID Numbers: ACZ ROS 01