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

• 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: Dermira, Inc.
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Olumacostat Glasaretil Gel, 7.5%, Phase 1	Olumacostat Glasaretil Gel, 7.5%, Phase 2a	Olumacostat Glasaretil Gel, Vehicle, Phase 2a	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 in Phase 2a
Description	Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12 in Phase 2a
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat

Arm/Group Title	Olumacostat Glasaretil Gel, 7.5%, Phase 2a	Olumacostat Glasaretil Gel, Vehicle, Phase 2a
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)

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
Description	Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12 in Phase 2a
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat

Arm/Group Title	Olumacostat Glasaretil Gel, 7.5%, Phase 2a	Olumacostat Glasaretil Gel, Vehicle, Phase 2a
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)

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
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; - Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion; - Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions); - 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; - 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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat

Arm/Group Title	Olumacostat Glasaretil Gel, 7.5%, Phase 2a	Olumacostat Glasaretil Gel, Vehicle, Phase 2a
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%

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

Adverse Events

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
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%)
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
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Reema Singh
• Organization: Dermira, Inc.
• Phone: 650-421-2951
• EMail: reema.singh@dermira.com

• 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