Trial Outcomes & Findings for Evaluation of Topical Application of BMX-010 in Subjects With Acne Vulgaris. (NCT NCT03752242)

Last Updated: 2023-09-21

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

28 days

Results posted on

2023-09-21

Participant Flow

Participant milestones

Participant milestones
Measure	BMX-010 0.03% Approximately 30 subjects will receive BMX-010 0.03% for 7-28 days to be applied topically to Acne of the face. BMX-010 0.3%: Safety and efficacy of BMX-010 in topical treatment of acne.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Topical Application of BMX-010 in Subjects With Acne Vulgaris.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BMX-010 0.03% n=2 Participants Approximately 30 subjects will receive BMX-010 0.03% for 7-28 days to be applied topically to Acne of the face. BMX-010 0.3%: Safety and efficacy of BMX-010 in topical treatment of acne.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	51 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants
Inflammatory Lesions	12 count STANDARD_DEVIATION 8 • n=5 Participants
Non-Inflammatory Lesions	26 count STANDARD_DEVIATION 24 • n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: 2 subjects enrolled and both were treated twice a day, so we were unable to determine this outcome. We will report the IGA scores collected, however this data is insufficient to determine optimal dosing (once a day or twice a day), since the only subjects enrolled were treated twice a day.

Outcome measures

Outcome measures
Measure	BMX-010 0.03% n=2 Participants Approximately 30 subjects will receive BMX-010 0.03% for 7-28 days to be applied topically to Acne of the face. BMX-010 0.3%: Safety and efficacy of BMX-010 in topical treatment of acne.
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.	2.5 score on a scale Standard Deviation .5

PRIMARY outcome

Timeframe: 43 days

Population: all of the subjects enrolled in the study

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

Outcome measures

Outcome measures
Measure	BMX-010 0.03% n=2 Participants Approximately 30 subjects will receive BMX-010 0.03% for 7-28 days to be applied topically to Acne of the face. BMX-010 0.3%: Safety and efficacy of BMX-010 in topical treatment of acne.
Evaluate the Efficacy of BMX-010 in Treatment of Acne Vulgaris.	2.5 score on a scale Standard Deviation .5

SECONDARY outcome

Timeframe: 43 days

Population: Total number of subjects enrolled (n=2)

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.

Outcome measures

Outcome measures
Measure	BMX-010 0.03% n=2 Participants Approximately 30 subjects will receive BMX-010 0.03% for 7-28 days to be applied topically to Acne of the face. BMX-010 0.3%: Safety and efficacy of BMX-010 in topical treatment of acne.
Assess the Mean Percent Reduction Change in Inflammatory Lesion Counts From Baseline to End of Study.	7.5 percentage of change Standard Deviation 5.5

SECONDARY outcome

Timeframe: 43 days

Population: the total number of subjects enrolled (n=2)

Non-Inflammatory lesions will be counted at each study visit.

Outcome measures

Outcome measures
Measure	BMX-010 0.03% n=2 Participants Approximately 30 subjects will receive BMX-010 0.03% for 7-28 days to be applied topically to Acne of the face. BMX-010 0.3%: Safety and efficacy of BMX-010 in topical treatment of acne.
Assess the Mean Percent Reduction Change in Noninflammatory Lesion Counts From Baseline to End of Study.	25 percentage of change Standard Deviation 25

Adverse Events

BMX-010 0.03%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Operations

BioMimetix

Phone: 303-862-7268

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place