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A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT03073486
Recruitment Status : Completed
First Posted : March 8, 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 744
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 493 251
Completed 405 207
Not Completed 88 44
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 493 251 744
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 493 participants 251 participants 744 participants
<=18 years
304
  61.7%
147
  58.6%
451
  60.6%
Between 18 and 65 years
189
  38.3%
104
  41.4%
293
  39.4%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 493 participants 251 participants 744 participants
19.2  (6.98) 19.2  (7.26) 19.2  (7.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 493 participants 251 participants 744 participants
Female
294
  59.6%
145
  57.8%
439
  59.0%
Male
199
  40.4%
106
  42.2%
305
  41.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 493 participants 251 participants 744 participants
Hispanic or Latino
88
  17.8%
52
  20.7%
140
  18.8%
Not Hispanic or Latino
393
  79.7%
196
  78.1%
589
  79.2%
Unknown or Not Reported
12
   2.4%
3
   1.2%
15
   2.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 493 participants 251 participants 744 participants
American Indian or Alaska Native
4
   0.8%
0
   0.0%
4
   0.5%
Asian
35
   7.1%
9
   3.6%
44
   5.9%
Native Hawaiian or Other Pacific Islander
1
   0.2%
1
   0.4%
2
   0.3%
Black or African American
90
  18.3%
54
  21.5%
144
  19.4%
White
342
  69.4%
178
  70.9%
520
  69.9%
More than one race
21
   4.3%
9
   3.6%
30
   4.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 493 participants 251 participants 744 participants
Canada 44 22 66
United States 393 200 593
Australia 56 29 85
Fitzpatrick Skin Type   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 493 participants 251 participants 744 participants
Type I
33
   6.7%
13
   5.2%
46
   6.2%
Type II
99
  20.1%
61
  24.3%
160
  21.5%
Type III
133
  27.0%
58
  23.1%
191
  25.7%
Type IV
112
  22.7%
57
  22.7%
169
  22.7%
Type V
51
  10.3%
26
  10.4%
77
  10.3%
Type VI
65
  13.2%
36
  14.3%
101
  13.6%
[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 493 251
Least Squares Mean (Standard Deviation)
Unit of Measure: Lesions
-17.0  (12.16) -15.4  (11.95)
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 0.2301
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 493 251
Least Squares Mean (Standard Deviation)
Unit of Measure: Lesions
-18.0  (23.37) -17.6  (22.64)
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 0.6888
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 493 251
Measure Type: Count of Participants
Unit of Measure: Participants
Success
80
  16.2%
30
  12.0%
Failure
413
  83.8%
221
  88.0%
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 0.1361
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   0/491 (0.00%)   0/248 (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   1/491 (0.20%)   0/248 (0.00%) 
Psychiatric disorders     
Suicidal ideation   1/491 (0.20%)  0/248 (0.00%) 
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   108/491 (22.00%)   28/248 (11.29%) 
General disorders     
Application site dryness   15/491 (3.05%)  2/248 (0.81%) 
Application site erythema   28/491 (5.70%)  3/248 (1.21%) 
Application site pain   30/491 (6.11%)  6/248 (2.42%) 
Application site pruritus   38/491 (7.74%)  17/248 (6.85%) 
Infections and infestations     
Nasopharyngitis   9/491 (1.83%)  7/248 (2.82%) 
Upper respiratory tract infection   20/491 (4.07%)  5/248 (2.02%) 
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: NCT03073486     History of Changes
Other Study ID Numbers: DRM01B-ACN04
First Submitted: March 3, 2017
First Posted: March 8, 2017
Results First Submitted: December 20, 2018
Results First Posted: February 5, 2019
Last Update Posted: February 5, 2019