A Study of S5G4T-1 in the Treatment of Papular-Pustular Rosacea
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To assess the efficacy and safety of S5G4T-1 compared to S5G4T-1 Vehicle when applied once daily for 12 weeks in patients with papulopustular rosacea
Condition or disease
Drug: S5G4T-1Drug: S5G4T-2
In this Phase 3, double blind, vehicle controlled study, patients will be admitted into this multi center, double blind, randomized, vehicle controlled, parallel group pivotal study only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. Male and female patients at least 18 years of age with moderate or severe papulopustular rosacea will be eligible for enrollment for daily treatment with S5G4T-1 or its vehicle for 12 weeks.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patient must sign an Institutional Review Board (IRB) approved written informed consent for this study.
Male and female 18 years of age and older.
Patients must have clinical diagnosis of moderate to severe rosacea.
Have a minimum total of 15.
Have two nodules or less .
Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation or were found to have positive pregnancy test at baseline or screening visits.
Presence of more than 2 facial nodules or any nodule greater than 1 cm.
Current or past ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.