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A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT03028363
Recruitment Status : Completed
First Posted : January 23, 2017
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Dermira, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Olumacostat Glasaretil Gel, 5.0%
Other: Olumacostat Glasaretil Gel, Vehicle
Enrollment 759
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Olumacostat Glasaretil Gel, 5.0% Olumacostat Glasaretil Gel, Vehicle
Hide Arm/Group Description Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Period Title: Overall Study
Started 498 261
Completed 420 228
Not Completed 78 33
Arm/Group Title Olumacostat Glasaretil Gel, 5.0% Olumacostat Glasaretil Gel, Vehicle Total
Hide Arm/Group Description Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 498 261 759
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 498 participants 261 participants 759 participants
<=18 years
289
  58.0%
140
  53.6%
429
  56.5%
Between 18 and 65 years
209
  42.0%
121
  46.4%
330
  43.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 498 participants 261 participants 759 participants
19.4  (6.58) 20.1  (7.14) 19.7  (6.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 498 participants 261 participants 759 participants
Female
286
  57.4%
152
  58.2%
438
  57.7%
Male
212
  42.6%
109
  41.8%
321
  42.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 498 participants 261 participants 759 participants
Hispanic or Latino
150
  30.1%
68
  26.1%
218
  28.7%
Not Hispanic or Latino
346
  69.5%
193
  73.9%
539
  71.0%
Unknown or Not Reported
2
   0.4%
0
   0.0%
2
   0.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 498 participants 261 participants 759 participants
American Indian or Alaska Native
3
   0.6%
3
   1.1%
6
   0.8%
Asian
13
   2.6%
11
   4.2%
24
   3.2%
Native Hawaiian or Other Pacific Islander
3
   0.6%
0
   0.0%
3
   0.4%
Black or African American
79
  15.9%
43
  16.5%
122
  16.1%
White
373
  74.9%
191
  73.2%
564
  74.3%
More than one race
27
   5.4%
13
   5.0%
40
   5.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 498 participants 261 participants 759 participants
Canada
32
   6.4%
16
   6.1%
48
   6.3%
United States
431
  86.5%
226
  86.6%
657
  86.6%
Australia
35
   7.0%
19
   7.3%
54
   7.1%
Fitzpatrick Skin Type   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 498 participants 261 participants 759 participants
Type I
28
   5.6%
16
   6.1%
44
   5.8%
Type II
94
  18.9%
55
  21.1%
149
  19.6%
Type III
125
  25.1%
75
  28.7%
200
  26.4%
Type IV
115
  23.1%
55
  21.1%
170
  22.4%
Type V
79
  15.9%
29
  11.1%
108
  14.2%
Type VI
57
  11.4%
31
  11.9%
88
  11.6%
[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

1.Primary Outcome
Title Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12
Hide Description Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat
Arm/Group Title Olumacostat Glasaretil Gel, 5.0% Olumacostat Glasaretil Gel, Vehicle
Hide Arm/Group Description:
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Overall Number of Participants Analyzed 498 261
Least Squares Mean (Standard Deviation)
Unit of Measure: Lesions
-14.5  (14.85) -13.5  (14.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olumacostat Glasaretil Gel, 5.0%, Olumacostat Glasaretil Gel, Vehicle
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3430
Comments [Not Specified]
Method ANCOVA
Comments Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation
2.Primary Outcome
Title Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12
Hide Description Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat
Arm/Group Title Olumacostat Glasaretil Gel, 5.0% Olumacostat Glasaretil Gel, Vehicle
Hide Arm/Group Description:
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Overall Number of Participants Analyzed 498 261
Least Squares Mean (Standard Deviation)
Unit of Measure: Lesions
-14.1  (21.05) -11.8  (20.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olumacostat Glasaretil Gel, 5.0%, Olumacostat Glasaretil Gel, Vehicle
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1260
Comments [Not Specified]
Method ANCOVA
Comments Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation
3.Primary Outcome
Title 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
Hide Description

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
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat
Arm/Group Title Olumacostat Glasaretil Gel, 5.0% Olumacostat Glasaretil Gel, Vehicle
Hide Arm/Group Description:
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Overall Number of Participants Analyzed 498 261
Measure Type: Count of Participants
Unit of Measure: Participants
Success
95
  19.1%
54
  20.7%
Failure
403
  80.9%
207
  79.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olumacostat Glasaretil Gel, 5.0%, Olumacostat Glasaretil Gel, Vehicle
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5247
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic Regression (Firth's Penalized Likelihood), MCMC Multiple Imputation
Time Frame Baseline to Week 12
Adverse Event Reporting Description 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.
 
Arm/Group Title Olumacostat Glasaretil Gel, 5.0% Olumacostat Glasaretil Gel, Vehicle
Hide Arm/Group Description Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
All-Cause Mortality
Olumacostat Glasaretil Gel, 5.0% Olumacostat Glasaretil Gel, Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/485 (0.00%)   0/258 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Olumacostat Glasaretil Gel, 5.0% Olumacostat Glasaretil Gel, Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   1/485 (0.21%)   3/258 (1.16%) 
Gastrointestinal disorders     
Constipation   0/485 (0.00%)  1/258 (0.39%) 
Infections and infestations     
Appendicitis   0/485 (0.00%)  1/258 (0.39%) 
Nervous system disorders     
Epilepsy   1/485 (0.21%)  0/258 (0.00%) 
Psychiatric disorders     
Bipolar disorder   0/485 (0.00%)  1/258 (0.39%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Olumacostat Glasaretil Gel, 5.0% Olumacostat Glasaretil Gel, Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   89/485 (18.35%)   33/258 (12.79%) 
General disorders     
Application site dryness   13/485 (2.68%)  2/258 (0.78%) 
Application site erythema   13/485 (2.68%)  3/258 (1.16%) 
Application site pain   19/485 (3.92%)  11/258 (4.26%) 
Application site pruritus   13/485 (2.68%)  4/258 (1.55%) 
Infections and infestations     
Nasopharyngitis   15/485 (3.09%)  5/258 (1.94%) 
Upper respiratory tract infection   16/485 (3.30%)  8/258 (3.10%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Reema Singh
Organization: Dermira, Inc.
Phone: 650-421-2951
EMail: reema.singh@dermira.com
Layout table for additonal information
Responsible Party: Dermira, Inc.
ClinicalTrials.gov Identifier: NCT03028363     History of Changes
Other Study ID Numbers: DRM01B-ACN03
First Submitted: January 19, 2017
First Posted: January 23, 2017
Results First Submitted: November 28, 2018
Results First Posted: February 5, 2019
Last Update Posted: February 5, 2019