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

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT00249782
Collaborator
(none)
400
Enrollment
26
Locations
5.9
Duration (Months)
15.4
Patients Per Site
2.6
Patients Per Site Per Month

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
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 :
Nov 1, 2005
Actual Primary Completion Date :
May 1, 2006
Actual Study Completion Date :
May 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Radiant Research Birmingham Alabama United States 35209
2 Radiant Research Tucson Arizona United States 85710
3 East Bay Dermatology Medical Group, Inc. Fremont California United States 94538
4 Therapeutics Clinical Research San Diego California United States 92123
5 Clincial Research Specialists, Inc. Santa Monica California United States 90404
6 Cherry Creek Research, Inc Denver Colorado United States 80246
7 The Savin Center, PC New Haven Connecticut United States 06511
8 Visions Clinical Research Boynton Beach Florida United States 33437
9 Tampa Bay Medical Research Clearwater Florida United States 33761
10 FXM Research Miami Florida United States 33175
11 University Clinical Research, Inc. Pembroke Pines Florida United States 33024
12 MedaPhase, Inc. Newnan Georgia United States 30263
13 Welborn Clinic Evansville Indiana United States 478713
14 Dermatology Clinical Trials Unit Washington University St. Louis Missouri United States 63110
15 Skin Specialists, PC Omaha Nebraska United States 68144
16 Academic Dermatology Associates Albuquerque New Mexico United States 87106
17 Dermatology Consulting Services High Point North Carolina United States 27262
18 University Dermatology Consultants, Inc. Cincinnati Ohio United States 45219
19 Dermatology Research Associates Inc. Cincinnati Ohio United States 45230
20 Northwest Dermatology and Research Center Portland Oregon United States 97210
21 Oregon Medical Research Center Portland Oregon United States 97223
22 Paddington Testing Co., Inc. Philadelphia Pennsylvania United States 19103
23 Dermatology Research Association, Inc. Nashville Tennessee United States 37203
24 DermResearch, Inc. Austin Texas United States 78759
25 J&S Studies Inc. Bryan Texas United States 77802
26 Madison Skin & Research, Inc. Madison Wisconsin United States 53719

Sponsors and Collaborators

  • Allergan

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00249782
Other Study ID Numbers:
  • ACZ ROS 01
First Posted:
Nov 7, 2005
Last Update Posted:
May 30, 2011
Last Verified:
May 1, 2011
Keywords provided by , ,
rosacea, Papulopustular Rosacea,erythema, dapsone
Additional relevant MeSH terms:
Rosacea
Metronidazole
Dapsone

Study Results

No Results Posted as of May 30, 2011