Enrollment stopped for chemistry work on investigational product.
An Exploratory Trial to Evaluate the Clinical Effectiveness of a Topical Application of BMX-010 in Subjects With Acne Vulgaris.
Sponsor study identifier
interventional
2
1 country
1
Study Start
January 3, 2019
Actual (reported)Primary Completion
August 31, 2020
Actual (reported)Study Completion
August 31, 2020
Actual (reported)This is an exploratory Phase 2 trial of BMX-010 in patients with Acne Vulgaris which will be conducted in two parts.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 15, 2018
Actual (reported)November 23, 2018
Actual (reported)January 3, 2019
Actual (reported)August 31, 2020
Actual (reported)August 31, 2020
Actual (reported)September 21, 2023
Actual (reported)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
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
43 days
Assess the Mean Percent Reduction Change in Inflammatory Lesion Counts From Baseline to End of Study.
43 days
Assess the Mean Percent Reduction Change in Noninflammatory Lesion Counts From Baseline to End of Study.
43 days
Approximately 30 subjects will receive BMX-010 0.03% for 7-28 days to be applied topically to Acne of the face.
Safety and efficacy of BMX-010 in topical treatment of acne.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Colorado Skin Care
Englewood, Colorado, 80113, United States
The clinical trial was stopped after enrollment of 2 subjects for re-formulation of investigational product. Therefore, due to the small sample size data is uninterpretable.
2 participants (actual enrollment reported by the registry).
First Submitted
November 15, 2018
First Posted
November 23, 2018
Study Start
January 3, 2019
Actual (reported)A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris
Contact the study team to confirm eligibility.
Primary Completion
August 31, 2020
Actual (reported)Study Completion
August 31, 2020
Actual (reported)Last Updated
September 21, 2023
Results First Posted
September 21, 2023
Record last verified: 2023-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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