A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris
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ClinicalTrials.gov Identifier: NCT02431052 |
Recruitment Status :
Completed
First Posted : April 30, 2015
Results First Posted : February 26, 2019
Last Update Posted : July 20, 2021
|
Sponsor:
Dermira, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company ( Dermira, Inc. )
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Acne Vulgaris |
Interventions |
Drug: Olumacostat Glasaretil Other: Vehicle |
Enrollment | 420 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Olumacostat Glasaretil Gel, Vehicle QD | Olumacostat Glasaretil Gel, Vehicle BID | Olumacostat Glasaretil Gel, 4.0% QD | Olumacostat Glasaretil Gel, 7.5% QD | Olumacostat Glasaretil Gel, 7.5% BID |
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Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks | Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks | Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks | Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks | Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks |
Period Title: Overall Study | |||||
Started | 53 | 50 | 106 | 110 | 101 |
Completed | 42 | 46 | 94 | 94 | 86 |
Not Completed | 11 | 4 | 12 | 16 | 15 |
Baseline Characteristics
Arm/Group Title | Olumacostat Glasaretil Gel, Vehicle QD | Olumacostat Glasaretil Gel, Vehicle BID | Olumacostat Glasaretil Gel, 4.0% QD | Olumacostat Glasaretil Gel, 7.5% QD | Olumacostat Glasaretil Gel, 7.5% BID | Total | |
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Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks | Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks | Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks | Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks | Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks | Total of all reporting groups | |
Overall Number of Baseline Participants | 52 | 50 | 106 | 110 | 101 | 419 | |
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Intent-to-Treat
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
|||||||
Number Analyzed | 52 participants | 50 participants | 106 participants | 110 participants | 101 participants | 419 participants | |
<=18 years |
6 11.5%
|
3 6.0%
|
10 9.4%
|
15 13.6%
|
14 13.9%
|
48 11.5%
|
|
Between 18 and 65 years |
46 88.5%
|
47 94.0%
|
96 90.6%
|
95 86.4%
|
87 86.1%
|
371 88.5%
|
|
>=65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
|||||||
Number Analyzed | 52 participants | 50 participants | 106 participants | 110 participants | 101 participants | 419 participants | |
26.8 (7.65) | 26.7 (7.04) | 27 (8.13) | 26.4 (7.96) | 25.9 (8.26) | 26.5 (7.90) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 52 participants | 50 participants | 106 participants | 110 participants | 101 participants | 419 participants | |
Female |
38 73.1%
|
39 78.0%
|
77 72.6%
|
83 75.5%
|
79 78.2%
|
316 75.4%
|
|
Male |
14 26.9%
|
11 22.0%
|
29 27.4%
|
27 24.5%
|
22 21.8%
|
103 24.6%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||||
Number Analyzed | 52 participants | 50 participants | 106 participants | 110 participants | 101 participants | 419 participants | |
Hispanic or Latino |
12 23.1%
|
9 18.0%
|
24 22.6%
|
27 24.5%
|
32 31.7%
|
104 24.8%
|
|
Not Hispanic or Latino |
38 73.1%
|
41 82.0%
|
81 76.4%
|
83 75.5%
|
68 67.3%
|
311 74.2%
|
|
Unknown or Not Reported |
2 3.8%
|
0 0.0%
|
1 0.9%
|
0 0.0%
|
1 1.0%
|
4 1.0%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||||
Number Analyzed | 52 participants | 50 participants | 106 participants | 110 participants | 101 participants | 419 participants | |
American Indian or Alaska Native |
2 3.8%
|
1 2.0%
|
1 0.9%
|
1 0.9%
|
0 0.0%
|
5 1.2%
|
|
Asian |
1 1.9%
|
2 4.0%
|
4 3.8%
|
6 5.5%
|
6 5.9%
|
19 4.5%
|
|
Native Hawaiian or Other Pacific Islander |
1 1.9%
|
0 0.0%
|
2 1.9%
|
1 0.9%
|
0 0.0%
|
4 1.0%
|
|
Black or African American |
16 30.8%
|
12 24.0%
|
27 25.5%
|
24 21.8%
|
20 19.8%
|
99 23.6%
|
|
White |
28 53.8%
|
33 66.0%
|
69 65.1%
|
75 68.2%
|
72 71.3%
|
277 66.1%
|
|
More than one race |
4 7.7%
|
2 4.0%
|
3 2.8%
|
3 2.7%
|
3 3.0%
|
15 3.6%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 52 participants | 50 participants | 106 participants | 110 participants | 101 participants | 419 participants |
Canada |
11 21.2%
|
12 24.0%
|
25 23.6%
|
25 22.7%
|
24 23.8%
|
97 23.2%
|
|
United States |
41 78.8%
|
38 76.0%
|
81 76.4%
|
85 77.3%
|
77 76.2%
|
322 76.8%
|
|
Fitzpatrick Skin Type
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 52 participants | 50 participants | 106 participants | 110 participants | 101 participants | 419 participants |
Type I |
1 1.9%
|
2 4.0%
|
7 6.6%
|
12 10.9%
|
5 5.0%
|
27 6.4%
|
|
Type II |
9 17.3%
|
7 14.0%
|
17 16.0%
|
23 20.9%
|
20 19.8%
|
76 18.1%
|
|
Type III |
12 23.1%
|
17 34.0%
|
26 24.5%
|
28 25.5%
|
30 29.7%
|
113 27.0%
|
|
Type IV |
15 28.8%
|
13 26.0%
|
25 23.6%
|
22 20.0%
|
23 22.8%
|
98 23.4%
|
|
Type V |
8 15.4%
|
4 8.0%
|
9 8.5%
|
12 10.9%
|
13 12.9%
|
46 11.0%
|
|
Type VI |
7 13.5%
|
7 14.0%
|
22 20.8%
|
13 11.8%
|
10 9.9%
|
59 14.1%
|
|
[1]
Measure Description:
Fitzpatrick Skin Type is a scale to numerically classify skin color, defined by the response to ultraviolet (UV) light with the following categories: Type I Burns easily, rarely tans Type II Burns easily, tans minimally Type III Burns moderately, tans gradually Type IV Burns minimally, tans well Type V Rarely burns, tans profusely Type VI Never burns, deeply pigmented |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Chief Medical Officer |
Organization: | Eli Lilly and Company. |
Phone: | 800-545-5979 |
EMail: | ClinicalTrials.gov@lilly.com |
Responsible Party: | Eli Lilly and Company ( Dermira, Inc. ) |
ClinicalTrials.gov Identifier: | NCT02431052 |
Other Study ID Numbers: |
DRM01B-ACN02 |
First Submitted: | April 27, 2015 |
First Posted: | April 30, 2015 |
Results First Submitted: | January 31, 2019 |
Results First Posted: | February 26, 2019 |
Last Update Posted: | July 20, 2021 |