The objectives of this study are to assess the safety and efficacy DRM01 Topical Gel compared to vehicle in patients with acne vulgaris.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
420
Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12
Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12
Time frame: Baseline and Week 12
Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12
Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12
Time frame: Baseline and Week 12
Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12
Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12 Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions 1. \- Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion 2. \- Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) 3. \- Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion 4. \- Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions
Time frame: Baseline and Week 12
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Coastal Clinical Research, Inc.
Mobile, Alabama, United States
T. Joseph Raoof, MD, Inc.
Encino, California, United States
University Clinical Trials, Inc.
San Diego, California, United States
Tory Sullivan MD PA
North Miami Beach, Florida, United States
International Clinical Research - US, LLC
Sanford, Florida, United States
MOORE Clinical Research, Inc.
Tampa, Florida, United States
Visions Clinical Research
Wellington, Florida, United States
DermResearch, PLLC
Louisville, Kentucky, United States
Lawrence J. Green, MD, LLC
Rockville, Maryland, United States
Michigan Center for Skin Care Research
Clinton Township, Michigan, United States
...and 24 more locations