Trial Outcomes & Findings for A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris (NCT NCT02431052)
NCT ID: NCT02431052
Last Updated: 2021-07-20
Results Overview
Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
420 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2021-07-20
Participant Flow
Participant milestones
| Measure |
Olumacostat Glasaretil Gel, Vehicle QD
Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle BID
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, 4.0% QD
Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, 7.5% QD
Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, 7.5% BID
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
53
|
50
|
106
|
110
|
101
|
|
Overall Study
COMPLETED
|
42
|
46
|
94
|
94
|
86
|
|
Overall Study
NOT COMPLETED
|
11
|
4
|
12
|
16
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Olumacostat Glasaretil Gel, Vehicle BID
n=50 Participants
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, 4.0% QD
n=106 Participants
Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, 7.5% QD
n=110 Participants
Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, 7.5% BID
n=101 Participants
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
|
Total
n=419 Participants
Total of all reporting groups
|
Olumacostat Glasaretil Gel, Vehicle QD
n=52 Participants
Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
48 Participants
n=8 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
371 Participants
n=8 Participants
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
26.7 Years
STANDARD_DEVIATION 7.04 • n=7 Participants
|
27 Years
STANDARD_DEVIATION 8.13 • n=5 Participants
|
26.4 Years
STANDARD_DEVIATION 7.96 • n=4 Participants
|
25.9 Years
STANDARD_DEVIATION 8.26 • n=21 Participants
|
26.5 Years
STANDARD_DEVIATION 7.90 • n=8 Participants
|
26.8 Years
STANDARD_DEVIATION 7.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
316 Participants
n=8 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
103 Participants
n=8 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
104 Participants
n=8 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
311 Participants
n=8 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
99 Participants
n=8 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
72 Participants
n=21 Participants
|
277 Participants
n=8 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
97 Participants
n=8 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
322 Participants
n=8 Participants
|
41 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type I
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
1 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type II
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
76 Participants
n=8 Participants
|
9 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type III
|
17 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
113 Participants
n=8 Participants
|
12 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type IV
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
98 Participants
n=8 Participants
|
15 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type V
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
46 Participants
n=8 Participants
|
8 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type VI
|
7 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
59 Participants
n=8 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent-to-Treat
Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12
Outcome measures
| Measure |
Olumacostat Glasaretil Gel, Vehicle QD
n=52 Participants
Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks
Olumacostat Glasaretil
|
Olumacostat Glasaretil Gel, Vehicle BID
n=50 Participants
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Olumacostat Glasaretil
|
Olumacostat Glasaretil Gel, 4.0% QD
n=106 Participants
Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks
Olumacostat Glasaretil
|
Olumacostat Glasaretil Gel, 7.5% QD
n=110 Participants
Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks
Vehicle
|
Olumacostat Glasaretil Gel, 7.5% BID
n=101 Participants
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
Vehicle
|
|---|---|---|---|---|---|
|
Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12
|
-10.5 Lesions
Standard Deviation 9.79
|
-11.0 Lesions
Standard Deviation 9.04
|
-14.6 Lesions
Standard Deviation 9.22
|
-14.5 Lesions
Standard Deviation 9.49
|
-15.0 Lesions
Standard Deviation 9.35
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent-To-Treat
Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12
Outcome measures
| Measure |
Olumacostat Glasaretil Gel, Vehicle QD
n=52 Participants
Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks
Olumacostat Glasaretil
|
Olumacostat Glasaretil Gel, Vehicle BID
n=50 Participants
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Olumacostat Glasaretil
|
Olumacostat Glasaretil Gel, 4.0% QD
n=106 Participants
Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks
Olumacostat Glasaretil
|
Olumacostat Glasaretil Gel, 7.5% QD
n=110 Participants
Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks
Vehicle
|
Olumacostat Glasaretil Gel, 7.5% BID
n=101 Participants
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
Vehicle
|
|---|---|---|---|---|---|
|
Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12
|
-9.3 Lesions
Standard Deviation 15.62
|
-9.3 Lesions
Standard Deviation 15.07
|
-15.3 Lesions
Standard Deviation 15.17
|
-13.4 Lesions
Standard Deviation 15.42
|
-17.5 Lesions
Standard Deviation 15.15
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent-to-Treat
Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12 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, Vehicle QD
n=52 Participants
Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks
Olumacostat Glasaretil
|
Olumacostat Glasaretil Gel, Vehicle BID
n=50 Participants
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Olumacostat Glasaretil
|
Olumacostat Glasaretil Gel, 4.0% QD
n=106 Participants
Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks
Olumacostat Glasaretil
|
Olumacostat Glasaretil Gel, 7.5% QD
n=110 Participants
Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks
Vehicle
|
Olumacostat Glasaretil Gel, 7.5% BID
n=101 Participants
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
Vehicle
|
|---|---|---|---|---|---|
|
Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12
Success
|
4 Participants
|
6 Participants
|
23 Participants
|
21 Participants
|
26 Participants
|
|
Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12
Failure
|
48 Participants
|
44 Participants
|
83 Participants
|
89 Participants
|
75 Participants
|
Adverse Events
Olumacostat Glasaretil Gel, Vehicle QD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Olumacostat Glasaretil Gel, Vehicle BID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Olumacostat Glasaretil Gel, 4.0% QD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Olumacostat Glasaretil Gel, 7.5% QD
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Olumacostat Glasaretil Gel, 7.5% BID
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olumacostat Glasaretil Gel, Vehicle QD
n=52 participants at risk
Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle BID
n=50 participants at risk
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, 4.0% QD
n=106 participants at risk
Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, 7.5% QD
n=109 participants at risk
Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, 7.5% BID
n=101 participants at risk
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.00%
0/52 • 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%
0/50 • 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%
0/106 • 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.
|
0.92%
1/109 • 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%
0/101 • 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, Vehicle QD
n=52 participants at risk
Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle BID
n=50 participants at risk
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, 4.0% QD
n=106 participants at risk
Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, 7.5% QD
n=109 participants at risk
Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, 7.5% BID
n=101 participants at risk
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/52 • 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%
0/50 • 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.
|
3.8%
4/106 • 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%
6/109 • 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.
|
6.9%
7/101 • 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