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

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00249782
First received: November 3, 2005
Last updated: May 27, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Rosacea
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)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Allergan:

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

Enrollment: 400
Study Start Date: November 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249782

  Show 26 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Steven Garrett, MS, DDS QLT USA, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00249782     History of Changes
Other Study ID Numbers: ACZ ROS 01
Study First Received: November 3, 2005
Last Updated: May 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Allergan:
rosacea, Papulopustular Rosacea,erythema, dapsone

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Dapsone
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 18, 2014