A Study of S6G5T-3 in the Treatment of Acne Vulgaris
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To assess the efficacy of S6G5T-3 compared to its Vehicle when applied once daily for 12 weeks in Patients with acne vulgaris
Condition or disease
Drug: S6G5T-3Drug: S6G5T-8
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 9 years of age with facial acne vulgaris will be eligible for enrollment for daily treatment with S6G5T-3 or its vehicle S6G5T-8, for 12 weeks
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Layout table for eligibility information
Ages Eligible for Study:
9 Years and older (Child, 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 9 years of age and older.
Have two (2) or fewer cysts or nodules
More than two acne nodules or cysts (defined as an inflammatory lesion greater than or equal to 5 mm in diameter).
History of blood dyscrasia (e.g., leukemia, haemophilia, sickle cell anemia, multiple myeloma, etc.)
Underlying disease that requires the use of interfering topical or systemic therapy.
Other dermatological conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis, or rosacea.