A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

• Sponsor: Dermira, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03073486
• Collaborator: (none)
• Enrollment: 744
• Locations: 46
• Arms: 2
• Actual Duration (Months): 10.4
• Patients Per Site: 16.2
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil Gel compared to vehicle in patients with acne vulgaris

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Olumacostat Glasaretil Gel, 5.0%; Other: Olumacostat Glasaretil Gel, Vehicle	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 744 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Vehicle Controlled, Efficacy and Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
• Actual Study Start Date: Feb 6, 2017
• Actual Primary Completion Date: Dec 21, 2017
• Actual Study Completion Date: Dec 21, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Olumacostat Glasaretil Gel, 5.0% Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks	Drug: Olumacostat Glasaretil Gel, 5.0%; Gel containing Olumacostat Glasaretil; Other Names: DRM01
Placebo Comparator: Olumacostat Glasaretil Gel, Vehicle Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks	Other: Olumacostat Glasaretil Gel, Vehicle; Vehicle (placebo) gel

Outcome Measures

Primary Outcome Measures

1. Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 [Baseline and Week 12]

   Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12

2. Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 [Baseline and Week 12]

   Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12

3. 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 [Baseline and Week 12]

   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 - 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Signed informed consent and, for subjects under legal adult age, signed assent

• Age ≥ 9 years

• Clinical diagnosis of facial acne vulgaris defined as:

• At least 20 inflammatory lesions, and

• At least 20 non-inflammatory lesions, and

• Investigator Global Assessment of 3 or greater

Exclusion Criteria:

• Active cystic acne or acne conglobata, acne fulminans, and secondary acne

• Two or more active nodulocystic lesions on the face

• Clinically significant abnormal laboratory or ECG result

• Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days or 5 half-lives (whichever is longer) of the Baseline visit

• Treatment with over-the-counter topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid on the face within 2 weeks prior to Baseline

• Treatment with systemic antibiotics or systemic anti-acne drugs or topical retinoid within 4 weeks prior to Baseline

• Treatment with a new hormonal therapy or dose change to existing hormonal therapy within 12 weeks prior to Baseline (hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills).

• Use of androgen receptor blockers (such as spironolactone or flutamide) within 2 weeks prior to Baseline.

• Oral retinoid use (e.g., isotretinoin) within 12 months prior to Baseline or vitamin A supplements greater than 10,000 units/day within 6 months prior to Baseline

• Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Avant Research Associates, LLC	Guntersville	Alabama	United States	35976
2	Advanced Research Associates	Glendale	Arizona	United States	85308
3	Dermatology Trial Associates	Bryant	Arkansas	United States	72022
4	Northwest Arkansas Clinical Trials Center	Rogers	Arkansas	United States	72758
5	Center for Dermatology Clinical Research, Inc.	Fremont	California	United States	94538
6	Advanced Skincare Surgery & MedCenter	Fullerton	California	United States	92835
7	Northern California Research	Sacramento	California	United States	95821
8	TCR Medical Corporation	San Diego	California	United States	92123
9	Radiant Research, Inc.	Santa Rosa	California	United States	95405
10	Alpine Clinical Research Center	Boulder	Colorado	United States	80301
11	Center for Clincial and Cosmetic Research	Aventura	Florida	United States	33180
12	Florida Academic Centers Research & Education	Coral Gables	Florida	United States	33134
13	Aby's New GEneration Research Inc.	Hialeah	Florida	United States	33015
14	Health Awareness, Inc.	Jupiter	Florida	United States	33458
15	Floridian Research Institute	Miami	Florida	United States	33145
16	Pioneer Clinical Research	Pembroke Pines	Florida	United States	33028
17	Radiant Research, Inc.	Pinellas Park	Florida	United States	33781
18	MOORE Clinical Research, Inc	Tampa	Florida	United States	33609
19	Visions Clinical Research	Wellington	Florida	United States	44414
20	Marietta Dermatology Clinical Research, Inc.	Marietta	Georgia	United States	30060
21	Clinical Trials Management, LLC	Metairie	Louisiana	United States	70006
22	DelRicht Research	New Orleans	Louisiana	United States	70115
23	Henry Ford Medical Center, New Center One	Detroit	Michigan	United States	48202
24	JDR Dermatology Research, LLC	Las Vegas	Nevada	United States	89148
25	Skin Search of Rochester, Inc.	Rochester	New York	United States	14623
26	Sterling Research Group	Cincinnati	Ohio	United States	45246
27	The Skin Wellness Center	Knoxville	Tennessee	United States	37992
28	Clinical Research Associates, Inc.	Nashville	Tennessee	United States	37203
29	Tennessee Clinical Research Center	Nashville	Tennessee	United States	37215
30	Avant Research Associates	Beaumont	Texas	United States	77702
31	Synexus US, LP, dba, Research Across America	Dallas	Texas	United States	75234
32	Suzanne Bruce and Associates, P.A. The Center for Skin	Houston	Texas	United States	77056
33	Austin Institute for Clinical Research, Inc	Pflugerville	Texas	United States	78660
34	Houston Center for Clinical Research	Sugar Land	Texas	United States	77479
35	The Education & Research Foundation, Inc.	Lynchburg	Virginia	United States	24501
36	Premier Clinical Research	Spokane	Washington	United States	99202
37	The Skin Centre	Benowa		Australia	4217
38	Premier Specialists	Kogarah		Australia	2217
39	Sinclair Dermatology	Melbourne		Australia	3002
40	Burswood Dermatology	Victoria Park		Australia	6100
41	Veracity Clinical Research	Woolloongabba		Australia	4102
42	Enverus Medical Research	Surrey	British Columbia	Canada	V3V 006
43	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba	Canada	R3M 3Z4
44	DermEdge Research	Mississauga	Ontario	Canada	L5H 1G9
45	The Centre for Dermatology	Richmond Hill	Ontario	Canada	L4B 1A5
46	XLR8 Medical Research	Windsor	Ontario	Canada	N8W 1E6

Sponsors and Collaborators

• Dermira, Inc.

Investigators

• Study Director: Beth Zib, Dermira, Inc.

Study Documents (Full-Text)

• Study Protocol - Oct 6, 2016
• Statistical Analysis Plan - Sep 20, 2017

More Information

Publications

None provided.

• Responsible Party: Dermira, Inc.
• ClinicalTrials.gov Identifier: NCT03073486
• Other Study ID Numbers: DRM01B-ACN04
• First Posted: Mar 8, 2017
• Last Update Posted: Jul 20, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acne Vulgaris

Study Results

Participant Flow

Arm/Group Title	Olumacostat Glasaretil Gel, 5.0%	Olumacostat Glasaretil Gel, Vehicle
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

Baseline Characteristics

Arm/Group Title	Olumacostat Glasaretil Gel, 5.0%	Olumacostat Glasaretil Gel, Vehicle	Total
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 Participants	493	251	744
Age (Count of 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%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	19.2 (6.98)	19.2 (7.26)	19.2 (7.07)
Sex: Female, Male (Count of Participants)
Female	294 59.6%	145 57.8%	439 59%
Male	199 40.4%	106 42.2%	305 41%
Ethnicity (NIH/OMB) (Count of 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%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	4 0.8%	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%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Canada	44 8.9%	22 8.8%	66 8.9%
United States	393 79.7%	200 79.7%	593 79.7%
Australia	56 11.4%	29 11.6%	85 11.4%
Fitzpatrick Skin Type (Count of 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%	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%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat

Arm/Group Title	Olumacostat Glasaretil Gel, 5.0%	Olumacostat Glasaretil Gel, Vehicle
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
Measure Participants	493	251
Least Squares Mean (Standard Deviation) [Lesions]	-17.0 (12.16)	-15.4 (11.95)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Olumacostat Glasaretil Gel, 5.0%, Olumacostat Glasaretil Gel, Vehicle
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2301
	Comments
	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
Description	Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat

Arm/Group Title	Olumacostat Glasaretil Gel, 5.0%	Olumacostat Glasaretil Gel, Vehicle
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
Measure Participants	493	251
Least Squares Mean (Standard Deviation) [Lesions]	-18.0 (23.37)	-17.6 (22.64)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Olumacostat Glasaretil Gel, 5.0%, Olumacostat Glasaretil Gel, Vehicle
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6888
	Comments
	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
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 - 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, 5.0%	Olumacostat Glasaretil Gel, Vehicle
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
Measure Participants	493	251
Success	80 16.2%	30 12%
Failure	413 83.8%	221 88%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Olumacostat Glasaretil Gel, 5.0%, Olumacostat Glasaretil Gel, Vehicle
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1361
	Comments
	Method	Regression, Logistic
	Comments	Logistic Regression (Firth's Penalized Likelihood), MCMC Multiple Imputation

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, 5.0%		Olumacostat Glasaretil Gel, Vehicle
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/491 (0%)		0/248 (0%)
Serious Adverse Events
	Olumacostat Glasaretil Gel, 5.0%		Olumacostat Glasaretil Gel, Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/491 (0.2%)		0/248 (0%)
Psychiatric disorders
Suicidal ideation	1/491 (0.2%)		0/248 (0%)
Other (Not Including Serious) Adverse Events
	Olumacostat Glasaretil Gel, 5.0%		Olumacostat Glasaretil Gel, Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	108/491 (22%)		28/248 (11.3%)
General disorders
Application site dryness	15/491 (3.1%)		2/248 (0.8%)
Application site erythema	28/491 (5.7%)		3/248 (1.2%)
Application site pain	30/491 (6.1%)		6/248 (2.4%)
Application site pruritus	38/491 (7.7%)		17/248 (6.9%)
Infections and infestations
Nasopharyngitis	9/491 (1.8%)		7/248 (2.8%)
Upper respiratory tract infection	20/491 (4.1%)		5/248 (2%)

Limitations/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.