Trial Outcomes & Findings for A Safety, Tolerability and Preliminary Efficacy Study of DRM01B Topical Gel (NCT NCT01936324)
NCT ID: NCT01936324
Last Updated: 2021-07-20
Results Overview
Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12 in Phase 2a
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
114 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2021-07-20
Participant Flow
Participant milestones
| Measure |
Olumacostat Glasaretil Gel, 7.5%, Phase 1
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 7 days in healthy volunteers
|
Olumacostat Glasaretil Gel, 7.5%, Phase 2a
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle, Phase 2a
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
53
|
55
|
|
Overall Study
COMPLETED
|
6
|
47
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety, Tolerability and Preliminary Efficacy Study of DRM01B Topical Gel
Baseline characteristics by cohort
| Measure |
Olumacostat Glasaretil Gel, 7.5%, Phase 1
n=6 Participants
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 7 days in healthy volunteers
|
Olumacostat Glasaretil Gel, 7.5%, Phase 2a
n=53 Participants
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle, Phase 2a
n=55 Participants
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
40.0 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
23.9 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
26.5 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
26.0 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
6 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
|
Fitzpatrick Skin Type
Type I
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Fitzpatrick Skin Type
Type II
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Fitzpatrick Skin Type
Type III
|
3 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Fitzpatrick Skin Type
Type IV
|
1 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Fitzpatrick Skin Type
Type V
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Fitzpatrick Skin Type
Type VI
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent-to-Treat
Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12 in Phase 2a
Outcome measures
| Measure |
Olumacostat Glasaretil Gel, 7.5%, Phase 2a
n=53 Participants
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle, Phase 2a
n=55 Participants
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
|---|---|---|
|
Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 in Phase 2a
|
-19.865 Lesions
Standard Error 1.107
|
-14.296 Lesions
Standard Error 1.079
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent-to-Treat
Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12 in Phase 2a
Outcome measures
| Measure |
Olumacostat Glasaretil Gel, 7.5%, Phase 2a
n=53 Participants
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle, Phase 2a
n=55 Participants
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
|---|---|---|
|
Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 in Phase 2a
|
-20.131 Lesions
Standard Error 1.902
|
-12.357 Lesions
Standard Error 1.856
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent-to-Treat
Percentage of subjects who achieved ≥ 2-grade improvement in the investigator global assessment of acne (IGA) from baseline to Week 12 in Phase 2a Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions 1. \- Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion 2. \- Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) 3. \- Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion 4. \- Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions
Outcome measures
| Measure |
Olumacostat Glasaretil Gel, 7.5%, Phase 2a
n=53 Participants
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle, Phase 2a
n=55 Participants
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
|---|---|---|
|
Percentage of Subjects Who Achieved ≥ 2-grade Improvement in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 in Phase 2a
Success
|
13 Participants
|
4 Participants
|
|
Percentage of Subjects Who Achieved ≥ 2-grade Improvement in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 in Phase 2a
Failure
|
40 Participants
|
51 Participants
|
Adverse Events
Olumacostat Glasaretil Gel, 7.5%, Phase 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Olumacostat Glasaretil Gel, 7.5%, Phase 2a
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Olumacostat Glasaretil Gel, Vehicle, Phase 2a
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olumacostat Glasaretil Gel, 7.5%, Phase 1
n=6 participants at risk
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 7 days in healthy volunteers
|
Olumacostat Glasaretil Gel, 7.5%, Phase 2a
n=53 participants at risk
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle, Phase 2a
n=55 participants at risk
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Ankle Fracture Right
|
0.00%
0/6 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/53 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
1.8%
1/55 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
Other adverse events
| Measure |
Olumacostat Glasaretil Gel, 7.5%, Phase 1
n=6 participants at risk
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 7 days in healthy volunteers
|
Olumacostat Glasaretil Gel, 7.5%, Phase 2a
n=53 participants at risk
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle, Phase 2a
n=55 participants at risk
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
|---|---|---|---|
|
General disorders
Application site dryness
|
0.00%
0/6 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
7.5%
4/53 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
5.5%
3/55 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
|
General disorders
Application site erythema
|
0.00%
0/6 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
7.5%
4/53 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
0.00%
0/55 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
|
General disorders
Application site pain
|
0.00%
0/6 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
7.5%
4/53 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
5.5%
3/55 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
5.7%
3/53 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
1.8%
1/55 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
24.5%
13/53 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
12.7%
7/55 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
1.9%
1/53 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
5.5%
3/55 • Baseline to Week 12
The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place