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A Safety, Tolerability and Preliminary Efficacy Study of DRM01B Topical Gel

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ClinicalTrials.gov Identifier: NCT01936324
Recruitment Status : Completed
First Posted : September 6, 2013
Results First Posted : May 10, 2019
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Dermira, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Olumacostat Glasaretil Gel, 7.5%
Other: Olumacostat Glasaretil Gel, Vehicle
Enrollment 114
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Olumacostat Glasaretil Gel, 7.5%, Phase 1 Olumacostat Glasaretil Gel, 7.5%, Phase 2a Olumacostat Glasaretil Gel, Vehicle, Phase 2a
Hide Arm/Group Description Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 7 days in healthy volunteers Olumacostat Glasaretil Gel, 7.5%, 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 6 53 55
Completed 6 47 50
Not Completed 0 6 5
Arm/Group Title Olumacostat Glasaretil Gel, 7.5%, Phase 1 Olumacostat Glasaretil Gel, 7.5%, Phase 2a Olumacostat Glasaretil Gel, Vehicle, Phase 2a Total
Hide Arm/Group Description Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 7 days in healthy volunteers Olumacostat Glasaretil Gel, 7.5%, 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 6 53 55 114
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 53 participants 55 participants 114 participants
<=18 years
0
   0.0%
12
  22.6%
12
  21.8%
24
  21.1%
Between 18 and 65 years
6
 100.0%
41
  77.4%
43
  78.2%
90
  78.9%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 53 participants 55 participants 114 participants
40.0  (11.3) 23.9  (6.1) 26.5  (9.0) 26.0  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 53 participants 55 participants 114 participants
Female
2
  33.3%
33
  62.3%
38
  69.1%
73
  64.0%
Male
4
  66.7%
20
  37.7%
17
  30.9%
41
  36.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 53 participants 55 participants 114 participants
Hispanic or Latino
0
   0.0%
5
   9.4%
3
   5.5%
8
   7.0%
Not Hispanic or Latino
6
 100.0%
48
  90.6%
52
  94.5%
106
  93.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 53 participants 55 participants 114 participants
American Indian or Alaska Native
0
   0.0%
3
   5.7%
1
   1.8%
4
   3.5%
Asian
0
   0.0%
9
  17.0%
10
  18.2%
19
  16.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
6
  11.3%
5
   9.1%
11
   9.6%
White
5
  83.3%
33
  62.3%
38
  69.1%
76
  66.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  16.7%
2
   3.8%
1
   1.8%
4
   3.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Canada Number Analyzed 6 participants 53 participants 55 participants 114 participants
6
 100.0%
53
 100.0%
55
 100.0%
114
 100.0%
Fitzpatrick Skin Type   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 53 participants 55 participants 114 participants
Type I
0
   0.0%
3
   5.7%
3
   5.5%
6
   5.3%
Type II
2
  33.3%
8
  15.1%
14
  25.5%
24
  21.1%
Type III
3
  50.0%
18
  34.0%
18
  32.7%
39
  34.2%
Type IV
1
  16.7%
16
  30.2%
13
  23.6%
30
  26.3%
Type V
0
   0.0%
3
   5.7%
2
   3.6%
5
   4.4%
Type VI
0
   0.0%
5
   9.4%
5
   9.1%
10
   8.8%
[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 in Phase 2a
Hide Description Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12 in Phase 2a
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat
Arm/Group Title Olumacostat Glasaretil Gel, 7.5%, Phase 2a Olumacostat Glasaretil Gel, Vehicle, Phase 2a
Hide Arm/Group Description:
Olumacostat Glasaretil Gel, 7.5%, 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 53 55
Least Squares Mean (Standard Error)
Unit of Measure: Lesions
-19.865  (1.107) -14.296  (1.079)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olumacostat Glasaretil Gel, 7.5%, Phase 2a, Olumacostat Glasaretil Gel, Vehicle, Phase 2a
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model with terms of treatment, baseline lesion count, and center.
2.Primary Outcome
Title Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 in Phase 2a
Hide Description Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12 in Phase 2a
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat
Arm/Group Title Olumacostat Glasaretil Gel, 7.5%, Phase 2a Olumacostat Glasaretil Gel, Vehicle, Phase 2a
Hide Arm/Group Description:
Olumacostat Glasaretil Gel, 7.5%, 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 53 55
Least Squares Mean (Standard Error)
Unit of Measure: Lesions
-20.131  (1.902) -12.357  (1.856)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olumacostat Glasaretil Gel, 7.5%, Phase 2a, Olumacostat Glasaretil Gel, Vehicle, Phase 2a
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0032
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model with terms of treatment, baseline lesion count, and center
3.Primary Outcome
Title Percentage of Subjects Who Achieved ≥ 2-grade Improvement in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 in Phase 2a
Hide Description

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
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat
Arm/Group Title Olumacostat Glasaretil Gel, 7.5%, Phase 2a Olumacostat Glasaretil Gel, Vehicle, Phase 2a
Hide Arm/Group Description:
Olumacostat Glasaretil Gel, 7.5%, 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 53 55
Measure Type: Count of Participants
Unit of Measure: Participants
Success
13
  24.5%
4
   7.3%
Failure
40
  75.5%
51
  92.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olumacostat Glasaretil Gel, 7.5%, Phase 2a, Olumacostat Glasaretil Gel, Vehicle, Phase 2a
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0070
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test stratified by study center
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, 7.5%, Phase 1 Olumacostat Glasaretil Gel, 7.5%, Phase 2a Olumacostat Glasaretil Gel, Vehicle, Phase 2a
Hide Arm/Group Description Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 7 days in healthy volunteers Olumacostat Glasaretil Gel, 7.5%, 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, 7.5%, Phase 1 Olumacostat Glasaretil Gel, 7.5%, Phase 2a Olumacostat Glasaretil Gel, Vehicle, Phase 2a
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/53 (0.00%)   0/55 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Olumacostat Glasaretil Gel, 7.5%, Phase 1 Olumacostat Glasaretil Gel, 7.5%, Phase 2a Olumacostat Glasaretil Gel, Vehicle, Phase 2a
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/53 (0.00%)   1/55 (1.82%) 
Injury, poisoning and procedural complications       
Ankle Fracture Right   0/6 (0.00%)  0/53 (0.00%)  1/55 (1.82%) 
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 5%
Olumacostat Glasaretil Gel, 7.5%, Phase 1 Olumacostat Glasaretil Gel, 7.5%, Phase 2a Olumacostat Glasaretil Gel, Vehicle, Phase 2a
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   29/53 (54.72%)   17/55 (30.91%) 
General disorders       
Application site dryness   0/6 (0.00%)  4/53 (7.55%)  3/55 (5.45%) 
Application site erythema   0/6 (0.00%)  4/53 (7.55%)  0/55 (0.00%) 
Application site pain   0/6 (0.00%)  4/53 (7.55%)  3/55 (5.45%) 
Infections and infestations       
Gastroenteritis   0/6 (0.00%)  3/53 (5.66%)  1/55 (1.82%) 
Nasopharyngitis   0/6 (0.00%)  13/53 (24.53%)  7/55 (12.73%) 
Nervous system disorders       
Headache   0/6 (0.00%)  1/53 (1.89%)  3/55 (5.45%) 
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: NCT01936324     History of Changes
Other Study ID Numbers: DRM01B-ACN01
First Submitted: September 3, 2013
First Posted: September 6, 2013
Results First Submitted: January 31, 2019
Results First Posted: May 10, 2019
Last Update Posted: May 27, 2019