A Long-term Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

• Sponsor: Dermira, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03127956
• Collaborator: (none)
• Enrollment: 748
• Locations: 94
• Arm: 1
• Actual Duration (Months): 13.2
• Patients Per Site: 8
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The objective of this study is to assess the long-term safety of Olumacostat Glasaretil gel, 5.0% in patients with acne vulgaris

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 748 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Study Assessing Long-Term Safety of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
• Actual Study Start Date: Mar 21, 2017
• Actual Primary Completion Date: Apr 27, 2018
• Actual Study Completion Date: Apr 27, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Olumacostat Glasaretil Gel, 5.0% Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face	Drug: Olumacostat Glasaretil Gel, 5.0%; Gel containing Olumacostat Glasaretil; Other Names: DRM01B

Outcome Measures

Primary Outcome Measures

1. Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions [Day 1 - Week 36]

   Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions

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 or assent (for subjects under legal adult age)

• Completed Week 12 visit of either DRM01B-ACN03 or DRM01B-ACN04 studies.

• Willing to comply with the protocol. Subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol

• Willing to refrain from using any treatments on the face for acne vulgaris, other than the investigational product, including topical or systemic antibiotics.

Exclusion Criteria:

• Abnormal clinically significant findings on physical exam, vital signs or ECG at Week 12 visit of either the DRM01-ACN03 or DMR01-ACN04 studies that would make further treatment with Olumacostat Glasaretil Gel contraindicated, as determined by the Investigator

• Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study

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	Alliance Dermatology & MOHS Center	Phoenix	Arizona	United States	85032
4	Dermatology Trial Associates	Bryant	Arkansas	United States	72022
5	Northwest Arkansas Clinical Trials Center	Rogers	Arkansas	United States	72758
6	Anaheim Clinical Trials	Anaheim	California	United States	92801
7	Center for Dermatology Clinical Research, Inc.	Fremont	California	United States	94538
8	Advanced Skincare Surgery & MedCenter	Fullerton	California	United States	92835
9	Dermatology Research Associates	Los Angeles	California	United States	90045
10	Northern California Research	Sacramento	California	United States	95821
11	Rady Children's Hospital UCSD Pediatric and Adolescent Derm	San Diego	California	United States	92123
12	TCR Medical Corporation	San Diego	California	United States	92123
13	University Clinical Trials Inc.	San Diego	California	United States	92123
14	Radiant Research, Inc.	Santa Rosa	California	United States	95405
15	Alpine Clinical Research Center	Boulder	Colorado	United States	80301
16	Horizons Clinical Research Center, LLC	Denver	Colorado	United States	80220
17	Dermatology Physicians of CT	Shelton	Connecticut	United States	06484
18	Center for Clincial and Cosmetic Research	Aventura	Florida	United States	33180
19	Florida Academic Centers Research & Education	Coral Gables	Florida	United States	33134
20	Aby's New Generation Research Inc.	Hialeah	Florida	United States	33015
21	Health Awareness, Inc.	Jupiter	Florida	United States	33458
22	Finlay Medical Research	Miami	Florida	United States	33126
23	Floridian Research Institute	Miami	Florida	United States	33145
24	Pioneer Clinical Research	Pembroke Pines	Florida	United States	33028
25	Radiant Research, Inc.	Pinellas Park	Florida	United States	33781
26	Health Awareness, Inc	Port Saint Lucie	Florida	United States	34952
27	International Clinical Research-US, LLC	Sanford	Florida	United States	32771
28	Lenus Research & Medical Group	Sweetwater	Florida	United States	33172
29	MOORE Clinical Research, Inc	Tampa	Florida	United States	33609
30	Visions Clinical Research	Wellington	Florida	United States	33414
31	Research Institute of the Southeast, LLC	West Palm Beach	Florida	United States	33401
32	Marietta Dermatology Clinical Research, Inc.	Marietta	Georgia	United States	30060
33	Arlington Dermatology	Rolling Meadows	Illinois	United States	60008
34	Forefront Dermatology	Carmel	Indiana	United States	46032
35	Kansas City Dermatology, PA	Overland Park	Kansas	United States	66215
36	Skin Sciences, PLLC	Louisville	Kentucky	United States	40217
37	Clinical Trials Management, LLC	Metairie	Louisiana	United States	70006
38	DelRicht Research	New Orleans	Louisiana	United States	70115
39	Lawrence Jeffrey Green MD, LLC	Rockville	Maryland	United States	20850
40	Great Lakes Research Group, Inc	Bay City	Michigan	United States	48706
41	Henry Ford Medical Center, New Center One	Detroit	Michigan	United States	48202
42	Minnesota Clinical Study Center	Fridley	Minnesota	United States	55432
43	Mercy Research	Washington	Missouri	United States	63090
44	Meridian Clinical Research, LLC	Norfolk	Nebraska	United States	68701
45	Quality Clinical Research Inc.	Omaha	Nebraska	United States	68114
46	Meridian Clinical Research	Omaha	Nebraska	United States	68134
47	JDR Dermatology Research, LLC	Las Vegas	Nevada	United States	89148
48	Acne Treatment & Research Center	Morristown	New Jersey	United States	07960
49	Schweiger Dermatology, PLLC	New York	New York	United States	10022
50	Skin Search of Rochester, Inc.	Rochester	New York	United States	14623
51	DermResearchCenter of New York, Inc.	Stony Brook	New York	United States	11790
52	Sterling Research Group	Cincinnati	Ohio	United States	45246
53	Cyn3rgy Research	Gresham	Oregon	United States	97030
54	Clinical Partners, LLC	Johnston	Rhode Island	United States	02919
55	Meridian Clincial Research	Dakota Dunes	South Dakota	United States	57049
56	The Skin Wellness Center	Knoxville	Tennessee	United States	37922
57	International Clinical Research - Tennessee LLC	Murfreesboro	Tennessee	United States	37130
58	Clinical Research Associates, Inc.	Nashville	Tennessee	United States	37203
59	Tennessee Clinical Research Center	Nashville	Tennessee	United States	37215
60	DermResearch, Inc	Austin	Texas	United States	78759
61	Avant Research Associates	Beaumont	Texas	United States	77702
62	J&S Studies, Inc.	College Station	Texas	United States	77845
63	Synexus US, LP, dba, Research Across America	Dallas	Texas	United States	75234
64	Suzanne Bruce and Associates, P.A. The Center for Skin Research	Houston	Texas	United States	77056
65	Austin Institute for Clinical Research, Inc	Pflugerville	Texas	United States	78660
66	Synexus US, LP, dba, Research Across America	Plano	Texas	United States	75093
67	Progressive Clinical Research, PA	San Antonio	Texas	United States	78213
68	Clinical Trials of Texas, Inc.	San Antonio	Texas	United States	78229
69	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas	United States	78229
70	Houston Center for Clinical Research	Sugar Land	Texas	United States	77479
71	The Education & Research Foundation, Inc.	Lynchburg	Virginia	United States	24501
72	Virginia Clinical Research, Inc.	Norfolk	Virginia	United States	23502
73	Premier Clinical Research	Spokane	Washington	United States	99202
74	Woden Dermatology	Phillip	Australian Capital Territory	Australia	2606
75	Premier Specialists	Kogarah	New South Wales	Australia	2217
76	St George Dermatology and Skin Cancer Centre	Kogarah	New South Wales	Australia	2217
77	The Skin Centre	Benowa	Queensland	Australia	4217
78	Veracity Clinical Research	Woolloongabba	Queensland	Australia	4102
79	North Eastern Health Specialists	Hectorville	South Australia	Australia	5073
80	Skin & Cancer Foundation Inc.	Carlton	Victoria	Australia	3053
81	Sinclair Dermatology	East Melbourne	Victoria	Australia	3002
82	Fremantle Dermatology	Fremantle	Western Australia	Australia	6160
83	Burswood Dermatology	Victoria Park	Western Australia	Australia	6100
84	Institute for Skin Advancement	Calgary	Alberta	Canada	T3A 2N1
85	Enverus Medical Research	Surrey	British Columbia	Canada	V3V 0C6
86	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba	Canada	R3M 3Z4
87	SimcoDerm Medical and Surgical Dermatology Center	Barrie	Ontario	Canada	L4M 7G1
88	Lynderm Research Inc.	Markham	Ontario	Canada	L3P 1X2
89	DermEdge Research	Mississauga	Ontario	Canada	L5H 1G9
90	North Bay Dermatology Centre	North Bay	Ontario	Canada	P1B 3Z7
91	The Centre for Dermatology	Richmond Hill	Ontario	Canada	L4B 1A5
92	Research Toronto	Toronto	Ontario	Canada	M4W 2N2
93	XLR8 Medical Research	Windsor	Ontario	Canada	N8W 1E6
94	Windsor Research Inc.	Windsor	Ontario	Canada	N8W 5L7

Sponsors and Collaborators

• Dermira, Inc.

Investigators

• Study Director: Beth Zib, Dermira, Inc.

Study Documents (Full-Text)

• Study Protocol - Apr 24, 2017
• Statistical Analysis Plan - Apr 10, 2018

More Information

Publications

None provided.

• Responsible Party: Dermira, Inc.
• ClinicalTrials.gov Identifier: NCT03127956
• Other Study ID Numbers: DRM01B-ACN05
• First Posted: Apr 25, 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%
Arm/Group Description	Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face
Period Title: Overall Study
STARTED	748
COMPLETED	431
NOT COMPLETED	317

Baseline Characteristics

Arm/Group Title	Olumacostat Glasaretil Gel, 5.0%
Arm/Group Description	Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face
Overall Participants	741
Age (Count of Participants)
<=18 years	446 60.2%
Between 18 and 65 years	295 39.8%
>=65 years	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	19.3 (7.04)
Sex: Female, Male (Count of Participants)
Female	423 57.1%
Male	318 42.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	211 28.5%
Not Hispanic or Latino	522 70.4%
Unknown or Not Reported	8 1.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	4 0.5%
Asian	26 3.5%
Native Hawaiian or Other Pacific Islander	3 0.4%
Black or African American	133 17.9%
White	546 73.7%
More than one race	29 3.9%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Canada	30 4%
United States	625 84.3%
Australia	86 11.6%

Outcome Measures

1. Primary Outcome

Title	Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions
Description	Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions
Time Frame	Day 1 - Week 36

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Olumacostat Glasaretil Gel, 5.0%
Arm/Group Description	Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face
Measure Participants	741
Adverse Events (Mild)	197 26.6%
Adverse Events (Moderate)	124 16.7%
Adverse Events (Severe)	18 2.4%
Adverse Events (Not Reported)	402 54.3%
Burning/Stinging (None)	518 69.9%
Burning/Stinging (Mild)	11 1.5%
Burning/Stinging (Moderate)	2 0.3%
Burning/Stinging (Severe)	0 0%
Burning/Stinging (Not Reported)	210 28.3%
Pruritus (None)	500 67.5%
Pruritus (Mild)	29 3.9%
Pruritus (Moderate)	2 0.3%
Pruritus (Severe)	0 0%
Pruritus (Not Reported)	210 28.3%
Erythema (None)	469 63.3%
Erythema (Mild)	55 7.4%
Erythema (Moderate)	7 0.9%
Erythema (Severe)	0 0%
Erythema (Not Reported)	210 28.3%
Dryness (None)	485 65.5%
Dryness (Mild)	43 5.8%
Dryness (Moderate)	3 0.4%
Dryness (Severe)	0 0%
Dryness (Not Reported)	210 28.3%
Peeling (None)	507 68.4%
Peeling (Mild)	22 3%
Peeling (Moderate)	1 0.1%
Peeling (Severe)	0 0%
Peeling (Not Reported)	211 28.5%

Adverse Events

Time Frame	Baseline to Week 36
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%
Arm/Group Description	Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face
All Cause Mortality
	Olumacostat Glasaretil Gel, 5.0%
	Affected / at Risk (%)	# Events
Total	0/741 (0%)
Serious Adverse Events
	Olumacostat Glasaretil Gel, 5.0%
	Affected / at Risk (%)	# Events
Total	8/741 (1.1%)
Infections and infestations
Infectious mononucleosis	1/741 (0.1%)
Urinary tract infection	1/741 (0.1%)
Injury, poisoning and procedural complications
Ankle fracture	1/741 (0.1%)
Nervous system disorders
Epilepsy	1/741 (0.1%)
Psychiatric disorders
Depression	1/741 (0.1%)
Suicidal ideation	1/741 (0.1%)
Renal and urinary disorders
Nephrolithiasis	1/741 (0.1%)
Vascular disorders
Hypertension	1/741 (0.1%)
Other (Not Including Serious) Adverse Events
	Olumacostat Glasaretil Gel, 5.0%
	Affected / at Risk (%)	# Events
Total	281/741 (37.9%)
General disorders
Application site dryness	28/741 (3.8%)
Application site erythema	25/741 (3.4%)
Application site pain	29/741 (3.9%)
Application site pruritus	39/741 (5.3%)
Infections and infestations
Influenza	16/741 (2.2%)
Nasopharyngitis	49/741 (6.6%)
Upper respiratory tract infection	57/741 (7.7%)
Injury, poisoning and procedural complications
Sunburn	19/741 (2.6%)
Nervous system disorders
Headache	19/741 (2.6%)

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.