This is an exploratory Phase 2 trial of BMX-010 in patients with Acne Vulgaris which will be conducted in two parts.
Part A is designed to confirm the optimal formulation, strength, and dosing frequency of the study drug in patients with Acne. Up to 60 subjects will be enrolled in this part. Part B is designed to be a randomized, double-blind trial studying the optimal formulation, strength, and dosing frequency of BMX-010 as determined in Part A, compared to Placebo in patients with Acne. Up to 150 subjects will be enrolled in this part. In both parts, adult subjects with Acne will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Safety and efficacy of BMX-010 in topical treatment of acne.
Colorado Skin Care
Englewood, Colorado, United States
Determine Whether the Optimum Frequency of Topical Application of BMX-010 0.03% is Once a Day or Twice a Day Day or Twice Per Day for a Treatment Interval of 7 to 28 Days.
Assessed by change in the 5-point Investigator Global Assessment (IGA), compared amongst the group that is treated once a day versus twice a day. This will be measured weekly from Days 1-28. The Investigator global assessment scale is a global assessment of disease as the time of evaluation. The lowest number on the scale (0) is clear from disease while the highest number (4) is severe disease. Scores on the scale are: 0, 1, 2, 3, 4
Time frame: 28 days
Evaluate the Efficacy of BMX-010 in Treatment of Acne Vulgaris.
Assessed by change in the 5-point Investigator Global Assessment (IGA). This will be measured weekly from Days 1-28, followed by a final assessment two weeks after dosing ends at day 43. Assessed by change in the 5-point Investigator Global Assessment (IGA), compared amongst the group that is treated with study drug versus with placebo. This will be measured weekly from Days 1-28. The Investigator global assessment scale is a global assessment of disease as the time of evaluation. The lowest number on the scale (0) is clear from disease while the highest number (4) is severe disease. Scores on the scale are: 0, 1, 2, 3, 4
Time frame: 43 days
Assess the Mean Percent Reduction Change in Inflammatory Lesion Counts From Baseline to End of Study.
Inflammatory lesions will be counted at each study visit and the total change in the count of lesions will be assessed from baseline to day 43.
Time frame: 43 days
Assess the Mean Percent Reduction Change in Noninflammatory Lesion Counts From Baseline to End of Study.
Non-Inflammatory lesions will be counted at each study visit.
Time frame: 43 days
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