Trial Outcomes & Findings for BPX-01 Minocycline 1% Topical Gel for Reduction of Propionibacterium Acnes (NCT NCT02709096)
NCT ID: NCT02709096
Last Updated: 2017-09-14
Results Overview
P. Acnes cultures will be collected using the modified Kligman Method at each study visit. After plating, the samples will be cultured for 7 days and then evaluated.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Cultures will be evaluated at Baseline, Week 1, Week 2, Week 4 and Week 6. Values reported at week 4 compared to baseline.
Results posted on
2017-09-14
Participant Flow
Participant milestones
| Measure |
BPX-01, 1% Topical Gel
BPX-01, 1% Topical Gel; applied once daily to the face for four weeks.
BPX-01, 1% Topical Gel: topical gel, applied to the forehead, cheeks, nose and chin
|
BPX-01, Vehicle Gel
BPX-01, Vehicle Gel; applied once daily to the face for four weeks.
BPX-01 Vehicle Gel: topical gel, applied to the forehead, cheeks, nose and chin
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
11
|
|
Overall Study
COMPLETED
|
21
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
BPX-01, 1% Topical Gel
BPX-01, 1% Topical Gel; applied once daily to the face for four weeks.
BPX-01, 1% Topical Gel: topical gel, applied to the forehead, cheeks, nose and chin
|
BPX-01, Vehicle Gel
BPX-01, Vehicle Gel; applied once daily to the face for four weeks.
BPX-01 Vehicle Gel: topical gel, applied to the forehead, cheeks, nose and chin
|
|---|---|---|
|
Overall Study
non-compliance
|
1
|
1
|
Baseline Characteristics
BPX-01 Minocycline 1% Topical Gel for Reduction of Propionibacterium Acnes
Baseline characteristics by cohort
| Measure |
BPX-01, 1% Topical Gel
n=22 Participants
BPX-01, 1% Topical Gel; applied once daily to the face for four weeks.
BPX-01, 1% Topical Gel: topical gel, applied to the forehead, cheeks, nose and chin
|
BPX-01, Vehicle Gel
n=11 Participants
BPX-01, Vehicle Gel; applied once daily to the face for four weeks.
BPX-01 Vehicle Gel: topical gel, applied to the forehead, cheeks, nose and chin
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
n=93 Participants
|
34 years
n=4 Participants
|
32 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=93 Participants
|
11 participants
n=4 Participants
|
33 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Cultures will be evaluated at Baseline, Week 1, Week 2, Week 4 and Week 6. Values reported at week 4 compared to baseline.Population: Per protocol population included all subjects with evaluable data and no major protocol violations.
P. Acnes cultures will be collected using the modified Kligman Method at each study visit. After plating, the samples will be cultured for 7 days and then evaluated.
Outcome measures
| Measure |
BPX-01, 1% Topical Gel
n=17 Participants
BPX-01, 1% Topical Gel; applied once daily to the face for four weeks.
BPX-01, 1% Topical Gel: topical gel, applied to the forehead, cheeks, nose and chin
|
BPX-01, Vehicle Gel
n=7 Participants
BPX-01, Vehicle Gel; applied once daily to the face for four weeks.
BPX-01 Vehicle Gel: topical gel, applied to the forehead, cheeks, nose and chin
|
|---|---|---|
|
Logarithmic Change in Colony Counts of Facial Propionibacterium Acnes
|
-1.0376 log change in colony forming units
Standard Deviation 0.5479
|
-0.4614 log change in colony forming units
Standard Deviation 0.4042
|
Adverse Events
BPX-01, 1% Topical Gel
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BPX-01, Vehicle Gel
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BPX-01, 1% Topical Gel
n=22 participants at risk
BPX-01, 1% Topical Gel; applied once daily to the face for four weeks.
BPX-01, 1% Topical Gel: topical gel, applied to the forehead, cheeks, nose and chin
|
BPX-01, Vehicle Gel
n=11 participants at risk
BPX-01, Vehicle Gel; applied once daily to the face for four weeks.
BPX-01 Vehicle Gel: topical gel, applied to the forehead, cheeks, nose and chin
|
|---|---|---|
|
Renal and urinary disorders
Kidney stone
|
0.00%
0/22 • 6 weeks
|
9.1%
1/11 • Number of events 1 • 6 weeks
|
Other adverse events
| Measure |
BPX-01, 1% Topical Gel
n=22 participants at risk
BPX-01, 1% Topical Gel; applied once daily to the face for four weeks.
BPX-01, 1% Topical Gel: topical gel, applied to the forehead, cheeks, nose and chin
|
BPX-01, Vehicle Gel
n=11 participants at risk
BPX-01, Vehicle Gel; applied once daily to the face for four weeks.
BPX-01 Vehicle Gel: topical gel, applied to the forehead, cheeks, nose and chin
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
9.1%
2/22 • Number of events 2 • 6 weeks
|
0.00%
0/11 • 6 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
4.5%
1/22 • Number of events 1 • 6 weeks
|
0.00%
0/11 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/22 • 6 weeks
|
9.1%
1/11 • Number of events 1 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus infection
|
4.5%
1/22 • Number of events 1 • 6 weeks
|
0.00%
0/11 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place