A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Dose-ranging Study in the Treatment of Acne Vulgaris,
This will be a Phase 2, multicenter, randomized, double-blinded, dose-ranging, parallel arm comparison study in male and non-pregnant female subjects, 9 through 45 years of age (inclusive) with facial acne vulgaris. This dose-ranging study, intended to identify the dose(s), will consist of 7 study visits over 14 weeks:
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
480
Topical Gel
Topical Gel
Vyome Therapeutics Inc.
Ontario, California, United States
Vyome Therapeutics Inc.
Sherman Oaks, California, United States
Vyome Therapeutics Inc.
Brandon, Florida, United States
Inflammatory lesion counts
Absolute Change from Baseline in inflammatory lesion counts in each treatment arm at Week 12.
Time frame: 12 weeks
Investigator's Global Assessment of Inflammatory Acne (IGA) score
Proportion of subjects achieving success at Week 12, with success defined as Investigator's Global Assessment of Inflammatory Acne (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from Baseline.
Time frame: 12 weeks
Percent change in inflammatory lesion counts
Percent change from Baseline in inflammatory lesion counts in each treatment arm at Week 12
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vyome Therapeutics Inc.
Coral Gables, Florida, United States
Vyome Therapeutics Inc
Miami, Florida, United States
Vyome Therapeutics Inc.
Winter Park, Florida, United States
Vyome Therapeutics Inc.
High Point, North Carolina, United States
Vyome Therapeutics Inc.
Hazleton, Pennsylvania, United States
Vyome Therapeutics Inc.
Upper Saint Clair, Pennsylvania, United States
Vyome Therapeutics Inc.
Mt. Pleasant, South Carolina, United States
...and 2 more locations