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

Rosacea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00249782
• Other study ID #: ACZ ROS 01
• Status: Completed
• Phase: Phase 2
• First received: November 3, 2005
• Last updated: May 27, 2011
• Start date: November 2005
• Est. completion date: May 2006

Study information

• Verified date: May 2011
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• Vehicle control, 2x/day

• ACZONE (dapsone) Gel, 5%, 2x/day

• ACZONE (dapsone) Gel, 5%, 1x/day

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

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

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	DermResearch, Inc.	Austin	Texas
United States	Radiant Research	Birmingham	Alabama
United States	Visions Clinical Research	Boynton Beach	Florida
United States	J&S Studies Inc.	Bryan	Texas
United States	Dermatology Research Associates Inc.	Cincinnati	Ohio
United States	University Dermatology Consultants, Inc.	Cincinnati	Ohio
United States	Tampa Bay Medical Research	Clearwater	Florida
United States	Cherry Creek Research, Inc	Denver	Colorado
United States	Welborn Clinic	Evansville	Indiana
United States	East Bay Dermatology Medical Group, Inc.	Fremont	California
United States	Dermatology Consulting Services	High Point	North Carolina
United States	Madison Skin & Research, Inc.	Madison	Wisconsin
United States	FXM Research	Miami	Florida
United States	Dermatology Research Association, Inc.	Nashville	Tennessee
United States	The Savin Center, PC	New Haven	Connecticut
United States	MedaPhase, Inc.	Newnan	Georgia
United States	Skin Specialists, PC	Omaha	Nebraska
United States	University Clinical Research, Inc.	Pembroke Pines	Florida
United States	Paddington Testing Co., Inc.	Philadelphia	Pennsylvania
United States	Northwest Dermatology and Research Center	Portland	Oregon
United States	Oregon Medical Research Center	Portland	Oregon
United States	Therapeutics Clinical Research	San Diego	California
United States	Clincial Research Specialists, Inc.	Santa Monica	California
United States	Dermatology Clinical Trials Unit Washington University	St. Louis	Missouri
United States	Radiant Research	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Percent change and change from baseline in inflammatory lesion counts;
Primary	"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;
Primary	Erythema & telangiectasia scores;
Primary	Lesion counts over time
Secondary	Safety: Adverse events and concomitant medications; Local symptom scores; Hematology and chemistry laboratory parameters; Vital signs
Secondary	Other: Plasma dapsone concentrations