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Keep this study
Lead
Allergan
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).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | A Phase II, Randomized Study of ACZONE™ (Dapsone) Gel, 5% for Papulopustular Rosacea.
