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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00249782
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : May 30, 2011
Sponsor:
Information provided by:
Allergan

Brief Summary:

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 or disease Intervention/treatment 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

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  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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
Study Start Date : November 2005
Primary Completion Date : May 2006
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea
Drug Information available for: Dapsone
U.S. FDA Resources




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00249782


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

ClinicalTrials.gov Identifier: NCT00249782     History of Changes
Other Study ID Numbers: ACZ ROS 01
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: May 30, 2011
Last Verified: May 2011

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

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