Trial Outcomes & Findings for Open Label Photo-Documentation Study Of BPX-01 Minocycline Gel (NCT NCT02946788)
NCT ID: NCT02946788
Last Updated: 2022-07-26
Results Overview
difference in number of inflammatory lesions at week 12 as compared to baseline
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-07-26
Participant Flow
Participant milestones
| Measure |
BPX-01 1%
BPX-01 1% minocycline topical gel
Minocycline: BPX-01 1 or 2% topical gel will be applied to face once daily before bedtime
|
BPX-01 2%
BPX-01 2% minocycline topical gel
Minocycline: BPX-01 1 or 2% topical gel will be applied to face once daily before bedtime
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open Label Photo-Documentation Study Of BPX-01 Minocycline Gel
Baseline characteristics by cohort
| Measure |
BPX-01 1%
n=8 Participants
BPX-01 1% minocycline topical gel
Minocycline: BPX-01 1 or 2% topical gel will be applied to face once daily at bedtime
|
BPX-01 2%
n=10 Participants
BPX-01 2% minocycline topical gel
Minocycline: BPX-01 1 or 2% topical gel will be applied to face once daily at bedtime
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
25 years
n=99 Participants
|
25 years
n=107 Participants
|
25 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksdifference in number of inflammatory lesions at week 12 as compared to baseline
Outcome measures
| Measure |
BPX-01 1%
n=8 Participants
BPX-01 1% minocycline topical gel
Minocycline: BPX-01 1 or 2% topical gel will be applied to face once daily at bedtime
|
BPX-01 2%
n=10 Participants
BPX-01 2% minocycline topical gel
Minocycline: BPX-01 1 or 2% topical gel will be applied to face once daily at bedtime
|
|---|---|---|
|
Change From Baseline in Inflammatory Lesion Counts at Week 12
|
22.3 inflammatory lesions
Interval 10.0 to 32.0
|
19.0 inflammatory lesions
Interval 11.0 to 40.0
|
Adverse Events
BPX-01 1%
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BPX-01 2%
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BPX-01 1%
n=8 participants at risk
BPX-01 1% minocycline topical gel
Minocycline: BPX-01 1 or 2% topical gel will be applied to face once daily at bedtime
|
BPX-01 2%
n=10 participants at risk
BPX-01 2% minocycline topical gel
Minocycline: BPX-01 1 or 2% topical gel will be applied to face once daily at bedtime
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
facial redness
|
12.5%
1/8 • Number of events 1 • 8 months
|
0.00%
0/10 • 8 months
|
|
Skin and subcutaneous tissue disorders
facial dryness
|
12.5%
1/8 • Number of events 1 • 8 months
|
10.0%
1/10 • Number of events 1 • 8 months
|
|
Gastrointestinal disorders
bloody diarrhea
|
0.00%
0/8 • 8 months
|
10.0%
1/10 • Number of events 1 • 8 months
|
|
Infections and infestations
ear infection
|
0.00%
0/8 • 8 months
|
10.0%
1/10 • Number of events 1 • 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place