A Phase II, Randomized Study of ACZONE™ (Dapsone) Gel, 5% for Papulopustular Rosacea.
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|ClinicalTrials.gov Identifier: NCT00249782|
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : May 30, 2011
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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|
•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|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Primary Completion Date :||May 2006|
|Actual Study Completion Date :||May 2006|
- 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
- Safety: Adverse events and concomitant medications; Local symptom scores; Hematology and chemistry laboratory parameters; Vital signs
- Other: Plasma dapsone concentrations
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, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
To be eligible for the study, subjects must fulfill all of the following criteria:
- Men or women ≥18 years of age.
- A diagnosis of papulopustular rosacea, with ≥10 inflammatory lesions (papules and/or pustules) above the mandibular line at baseline.
- An Investigator Global Assessment (IGA) score ≥2
- In good physical and mental health.
- Signature of an approved informed consent form for the study and HIPAA authorization (if applicable).
- Willingness to comply with the protocol.
Subjects meeting any of the following criteria will be excluded from the study:
- 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.
- Current or past ocular rosacea, such as conjunctivitis, iritis, and keratitis, of sufficient severity to require topical or systemic antibiotics.
- Treatment with topical antibiotics, topical steroids and other topical rosacea treatments on the face within 14 days of Baseline and throughout the study.
- Treatment with systemic steroids within 30 days of Baseline and throughout the study.
- Treatment with any systemic antibiotics within 30 days of Baseline and throughout the study.
- Treatment with any systemic medication or therapy known to affect inflammatory responses within the 30 days prior to Baseline or throughout the study.
- Treatment with topical retinoids within 30 days or systemic retinoids within 180 days of Baseline and throughout the study.
- Treatment with physical modalities that could benefit rosacea are prohibited within 30 days of Baseline and throughout the study.
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
|Study Director:||Steven Garrett, MS, DDS||QLT USA, Inc.|
|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|
rosacea, Papulopustular Rosacea,erythema, dapsone
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