Clinical trial NCT00249782: A Phase II, Randomized Study of ACZONE™ (Dapsone) Gel, 5% for Papulopustular Rosacea.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rosacea
Keywords: rosacea, Papulopustular Rosacea,erythema, dapsone
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2005-11-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Efficacy: Percent change and change from baseline in inflammatory lesion counts;
measure: "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;
measure: Erythema & telangiectasia scores;
measure: Lesion counts over time
Secondary outcomes:
measure: Safety: Adverse events and concomitant medications; Local symptom scores; Hematology and chemistry laboratory parameters; Vital signs
measure: Other: Plasma dapsone concentrations
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Radiant Research
state: Alabama
city: Tucson
country: United States
facility: Radiant Research
state: Arizona
city: Fremont
country: United States
facility: East Bay Dermatology Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Santa Monica
country: United States
facility: Clincial Research Specialists, Inc.
state: California
city: Denver
country: United States
facility: Cherry Creek Research, Inc
state: Colorado
city: New Haven
country: United States
facility: The Savin Center, PC
state: Connecticut
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Miami
country: United States
facility: FXM Research
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: Newnan
country: United States
facility: MedaPhase, Inc.
state: Georgia
city: Evansville
country: United States
facility: Welborn Clinic
state: Indiana
city: St. Louis
country: United States
facility: Dermatology Clinical Trials Unit Washington University
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Cincinnati
country: United States
facility: University Dermatology Consultants, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Dermatology Research Associates Inc.
state: Ohio
city: Portland
country: United States
facility: Northwest Dermatology and Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Philadelphia
country: United States
facility: Paddington Testing Co., Inc.
state: Pennsylvania
city: Nashville
country: United States
facility: Dermatology Research Association, Inc.
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Bryan
country: United States
facility: J&S Studies Inc.
state: Texas
city: Madison
country: United States
facility: Madison Skin & Research, Inc.
state: Wisconsin
Study officials:
affiliation: QLT USA, Inc.
name: Steven Garrett, MS, DDS
role: STUDY_DIRECTOR
References: