Trial Outcomes & Findings for Evaluation of BTX 1503 in Patients With Moderate to Severe Acne Vulgaris (NCT NCT03573518)
NCT ID: NCT03573518
Last Updated: 2022-04-18
Results Overview
Summary of Treatment-Emergent Adverse Events by MedDra Preferred Term that Occurred with a Frequency \> 2% in any Treatment Group (Safety Population)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
368 participants
Primary outcome timeframe
Day 84
Results posted on
2022-04-18
Participant Flow
Participant milestones
| Measure |
BTX 1503 5% BID
BTX 1503 5% CBD (w/w) solution twice daily
|
BTX 1503 5% QD
BTX 1503 5% CBD (w/w) solution once daily
|
BTX 1503 2.5% QD
BTX 1503 2.5% CBD (w/w) solution once daily
|
Vehicle Combined (BID or QID)
Placebo BID + Placebo QD
=Placebo Combined group
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
92
|
92
|
92
|
92
|
|
Overall Study
COMPLETED
|
69
|
77
|
70
|
81
|
|
Overall Study
NOT COMPLETED
|
23
|
15
|
22
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of BTX 1503 in Patients With Moderate to Severe Acne Vulgaris
Baseline characteristics by cohort
| Measure |
BTX 1503 5% BID
n=92 Participants
BTX 1503 5% CBD (w/w) solution twice daily
|
BTX 1503 5% QD
n=92 Participants
BTX 1503 5% CBD (w/w) solution once daily
|
BTX 1503 2.5% QD
n=92 Participants
BTX 1503 2.5% CBD (w/w) solution once daily
|
Vehicle Combined (BID or QID)
n=92 Participants
Placebo BID + Placebo QD
=Placebo Combined group
|
Total
n=368 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
19.5 years
STANDARD_DEVIATION 6.65 • n=99 Participants
|
19.7 years
STANDARD_DEVIATION 5.99 • n=107 Participants
|
19.4 years
STANDARD_DEVIATION 5.98 • n=206 Participants
|
20.5 years
STANDARD_DEVIATION 6.14 • n=7 Participants
|
20.0 years
STANDARD_DEVIATION 6.17 • n=31 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
55 Participants
n=7 Participants
|
229 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
139 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
93 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
69 Participants
n=7 Participants
|
275 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
67 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
72 Participants
n=7 Participants
|
287 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Inflammatory Lesion Count
|
29.3 Lesions
STANDARD_DEVIATION 8.52 • n=99 Participants
|
28.5 Lesions
STANDARD_DEVIATION 8.95 • n=107 Participants
|
29.6 Lesions
STANDARD_DEVIATION 8.00 • n=206 Participants
|
29.1 Lesions
STANDARD_DEVIATION 8.25 • n=7 Participants
|
29.1 Lesions
STANDARD_DEVIATION 8.37 • n=31 Participants
|
PRIMARY outcome
Timeframe: Day 84Population: Safety Population
Summary of Treatment-Emergent Adverse Events by MedDra Preferred Term that Occurred with a Frequency \> 2% in any Treatment Group (Safety Population)
Outcome measures
| Measure |
BTX 1503 5% BID
n=92 Participants
BTX 1503 5% CBD (w/w) solution twice daily
|
BTX 1503 5% QD
n=91 Participants
BTX 1503 5% CBD (w/w) solution once daily
|
BTX 1503 2.5% QD
n=91 Participants
BTX 1503 2.5% CBD (w/w) solution once daily
|
Vehicle Combined (BID or QID)
n=91 Participants
Placebo BID + Placebo QD
=Placebo Combined group
|
|---|---|---|---|---|
|
Safety as Measured by Reported Adverse Events
Upper Respiratory tract infection
|
2 TEAEs
|
4 TEAEs
|
5 TEAEs
|
5 TEAEs
|
|
Safety as Measured by Reported Adverse Events
Viral upper respiratory tract infection
|
3 TEAEs
|
2 TEAEs
|
3 TEAEs
|
4 TEAEs
|
|
Safety as Measured by Reported Adverse Events
Headache
|
1 TEAEs
|
1 TEAEs
|
2 TEAEs
|
0 TEAEs
|
|
Safety as Measured by Reported Adverse Events
Acne
|
2 TEAEs
|
0 TEAEs
|
2 TEAEs
|
0 TEAEs
|
|
Safety as Measured by Reported Adverse Events
Cough
|
1 TEAEs
|
0 TEAEs
|
2 TEAEs
|
0 TEAEs
|
|
Safety as Measured by Reported Adverse Events
Oropharyngeal pain
|
0 TEAEs
|
2 TEAEs
|
0 TEAEs
|
1 TEAEs
|
SECONDARY outcome
Timeframe: Day 84Population: Intent-to-Treat Population
Summary of Absolute Change from Baseline in Inflammatory Count at Day 84 (Intent-to-Treat Population)
Outcome measures
| Measure |
BTX 1503 5% BID
n=92 Participants
BTX 1503 5% CBD (w/w) solution twice daily
|
BTX 1503 5% QD
n=92 Participants
BTX 1503 5% CBD (w/w) solution once daily
|
BTX 1503 2.5% QD
n=91 Participants
BTX 1503 2.5% CBD (w/w) solution once daily
|
Vehicle Combined (BID or QID)
n=92 Participants
Placebo BID + Placebo QD
=Placebo Combined group
|
|---|---|---|---|---|
|
Absolute Change From Baseline in Inflammatory Lesion Counts
|
-8.5 Lesions
Standard Deviation 12.57
|
-12 Lesions
Standard Deviation 12.58
|
-11.7 Lesions
Standard Deviation 12.57
|
-11.3 Lesions
Standard Deviation 12.57
|
Adverse Events
BTX 1503 5% BID
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
BTX 1503 5% QD
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
BTX 1503 2.5% QD
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Vehicle Combined (BID or QID)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BTX 1503 5% BID
n=92 participants at risk
BTX 1503 5% CBD (w/w) solution twice daily
|
BTX 1503 5% QD
n=91 participants at risk
BTX 1503 5% CBD (w/w) solution once daily
|
BTX 1503 2.5% QD
n=91 participants at risk
BTX 1503 2.5% CBD (w/w) solution once daily
|
Vehicle Combined (BID or QID)
n=91 participants at risk
Placebo BID + Placebo QD
=Placebo Combined group
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
2.2%
2/92 • Number of events 2 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
4.4%
4/91 • Number of events 4 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
5.5%
5/91 • Number of events 5 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
5.5%
5/91 • Number of events 5 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
|
Respiratory, thoracic and mediastinal disorders
Viral upper respiratory tract infection
|
3.3%
3/92 • Number of events 3 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
2.2%
2/91 • Number of events 2 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
3.3%
3/91 • Number of events 3 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
4.4%
4/91 • Number of events 4 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
|
Nervous system disorders
Headache
|
1.1%
1/92 • Number of events 1 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
1.1%
1/91 • Number of events 1 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
2.2%
2/91 • Number of events 2 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
0.00%
0/91 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.2%
2/92 • Number of events 2 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
0.00%
0/91 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
2.2%
2/91 • Number of events 2 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
0.00%
0/91 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/92 • Number of events 1 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
0.00%
0/91 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
2.2%
2/91 • Number of events 2 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
0.00%
0/91 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
|
Gastrointestinal disorders
Oorpharyngeal Pain
|
0.00%
0/92 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
2.2%
2/91 • Number of events 2 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
0.00%
0/91 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
1.1%
1/91 • Number of events 1 • Approximately 3 months
Reporting of AE's included reporting of pregnancy
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee As Study is a Multi-centre Study, no Publication of the Study results may be made until Publication of the results of the Multi-centre study or 2 years after Study Completion, whichever is sooner.
- Publication restrictions are in place
Restriction type: OTHER