Acne VulgarisPhase 3NCT03127956

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

A Phase 3 study testing Olumacostat Glasaretil Gel, 5.0% in people with Acne Vulgaris, run by Dermira, Inc. at 94 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 9 years and older
Conditions the study is for: Acne Vulgaris
What is being tested?: Olumacostat Glasaretil Gel, 5.0%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 748 participants
Where: 94 sitesin 3 countries
Study dates: 21 Mar 2017to 27 Apr 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

94 sites in 3 countries.

Country

City, postcode or hospital

94 sites in 3 countries

United States73 sites

Anaheim Clinical Trials
Anaheim, California, 92801
DermResearch, Inc
Austin, Texas, 78759
Center for Clincial and Cosmetic Research
Aventura, Florida, 33180
Great Lakes Research Group, Inc
Bay City, Michigan, 48706
Avant Research Associates
Beaumont, Texas, 77702
Alpine Clinical Research Center
Boulder, Colorado, 80301
Dermatology Trial Associates
Bryant, Arkansas, 72022
Forefront Dermatology
Carmel, Indiana, 46032
Sterling Research Group
Cincinnati, Ohio, 45246
J&S Studies, Inc.
College Station, Texas, 77845
Florida Academic Centers Research & Education
Coral Gables, Florida, 33134
Meridian Clincial Research
Dakota Dunes, South Dakota, 57049
Synexus US, LP, dba, Research Across America
Dallas, Texas, 75234
Horizons Clinical Research Center, LLC
Denver, Colorado, 80220
Henry Ford Medical Center, New Center One
Detroit, Michigan, 48202
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Advanced Skincare Surgery & MedCenter
Fullerton, California, 92835
Advanced Research Associates
Glendale, Arizona, 85308
Cyn3rgy Research
Gresham, Oregon, 97030
Avant Research Associates, LLC
Guntersville, Alabama, 35976
Aby's New Generation Research Inc.
Hialeah, Florida, 33015
Suzanne Bruce and Associates, P.A. The Center for Skin Research
Houston, Texas, 77056
Clinical Partners, LLC
Johnston, Rhode Island, 02919
Health Awareness, Inc.
Jupiter, Florida, 33458
The Skin Wellness Center
Knoxville, Tennessee, 37922
JDR Dermatology Research, LLC
Las Vegas, Nevada, 89148
Dermatology Research Associates
Los Angeles, California, 90045
Skin Sciences, PLLC
Louisville, Kentucky, 40217
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501
Marietta Dermatology Clinical Research, Inc.
Marietta, Georgia, 30060
Clinical Trials Management, LLC
Metairie, Louisiana, 70006
Finlay Medical Research
Miami, Florida, 33126
Floridian Research Institute
Miami, Florida, 33145
Acne Treatment & Research Center
Morristown, New Jersey, 07960
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, 37130
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
DelRicht Research
New Orleans, Louisiana, 70115
Schweiger Dermatology, PLLC
New York, New York, 10022
Meridian Clinical Research, LLC
Norfolk, Nebraska, 68701
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
Quality Clinical Research Inc.
Omaha, Nebraska, 68114
Meridian Clinical Research
Omaha, Nebraska, 68134
Kansas City Dermatology, PA
Overland Park, Kansas, 66215
Pioneer Clinical Research
Pembroke Pines, Florida, 33028
Austin Institute for Clinical Research, Inc
Pflugerville, Texas, 78660
Alliance Dermatology & MOHS Center
Phoenix, Arizona, 85032
Radiant Research, Inc.
Pinellas Park, Florida, 33781
Synexus US, LP, dba, Research Across America
Plano, Texas, 75093
Health Awareness, Inc
Port Saint Lucie, Florida, 34952
Skin Search of Rochester, Inc.
Rochester, New York, 14623
Lawrence Jeffrey Green MD, LLC
Rockville, Maryland, 20850
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, 72758
Arlington Dermatology
Rolling Meadows, Illinois, 60008
Northern California Research
Sacramento, California, 95821
Progressive Clinical Research, PA
San Antonio, Texas, 78213
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Rady Children's Hospital UCSD Pediatric and Adolescent Derm
San Diego, California, 92123
TCR Medical Corporation
San Diego, California, 92123
University Clinical Trials Inc.
San Diego, California, 92123
International Clinical Research-US, LLC
Sanford, Florida, 32771
Radiant Research, Inc.
Santa Rosa, California, 95405
Dermatology Physicians of CT
Shelton, Connecticut, 06484
Premier Clinical Research
Spokane, Washington, 99202
DermResearchCenter of New York, Inc.
Stony Brook, New York, 11790
Houston Center for Clinical Research
Sugar Land, Texas, 77479
Lenus Research & Medical Group
Sweetwater, Florida, 33172
MOORE Clinical Research, Inc
Tampa, Florida, 33609
Mercy Research
Washington, Missouri, 63090
Visions Clinical Research
Wellington, Florida, 33414
Research Institute of the Southeast, LLC
West Palm Beach, Florida, 33401

Other trials in United States

Canada11 sites

SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M 7G1
Institute for Skin Advancement
Calgary, Alberta, T3A 2N1
Lynderm Research Inc.
Markham, Ontario, L3P 1X2
DermEdge Research
Mississauga, Ontario, L5H 1G9
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5
Enverus Medical Research
Surrey, British Columbia, V3V 0C6
Research Toronto
Toronto, Ontario, M4W 2N2
XLR8 Medical Research
Windsor, Ontario, N8W 1E6
Windsor Research Inc.
Windsor, Ontario, N8W 5L7
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

Australia10 sites

The Skin Centre
Benowa, Queensland, 4217
Skin & Cancer Foundation Inc.
Carlton, Victoria, 3053
Sinclair Dermatology
East Melbourne, Victoria, 3002
Fremantle Dermatology
Fremantle, Western Australia, 6160
North Eastern Health Specialists
Hectorville, South Australia, 5073
Premier Specialists
Kogarah, New South Wales, 2217
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, 2217
Woden Dermatology
Phillip, Australian Capital Territory, 2606
Burswood Dermatology
Victoria Park, Western Australia, 6100
Veracity Clinical Research
Woolloongabba, Queensland, 4102

Other trials in Australia

About this study

Official title: An Open-Label Study Assessing Long-Term Safety of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

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

Conditions: Acne Vulgaris
Being tested: Olumacostat Glasaretil Gel, 5.0%
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Olumacostat Glasaretil Gel, 5.0%Drug
Also called DRM01B
Gel containing Olumacostat Glasaretil

Study groups in NCT03127956
Study group	Role	What they receive
Olumacostat Glasaretil Gel, 5.0%	Experimental	Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face Receives: Drug: Olumacostat Glasaretil Gel, 5.0%

What is being measured

The primary outcome is the main question the study is designed to answer.

Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions
Measured: Day 1 - Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Mar 201727 Apr 2018

First posted25 Apr 2017
Study start21 Mar 2017
Primary completion27 Apr 2018
Study completion27 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 748 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03127956
Sponsor's protocol ID: DRM01B-ACN05
Status last verified: Jul 2021
First submitted: 17 Apr 2017
Last updated: 20 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal

All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study Assessing Long-Term Safety of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
ClinicalTrials.gov ID: NCT03127956
Acronym / sponsor ID: DRM01B-ACN05
Conditions: Acne Vulgaris
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 748 participants (actual)
Lead sponsor: Dermira, Inc.Industry (pharma, biotech, devices)
Study start: 21 Mar 2017 (actual)
Primary completion: 27 Apr 2018 (actual)
Study completion: 27 Apr 2018 (actual)
First posted: 25 Apr 2017 (actual)
Results: Posted 5 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Olumacostat Glasaretil Gel, 5.0%	Experimental	Drug: Olumacostat Glasaretil Gel, 5.0%Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face

Who may qualify

Ages: 9 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Olumacostat Glasaretil Gel, 5.0%Also: DRM01BGel containing Olumacostat Glasaretil	Drug	Olumacostat Glasaretil Gel, 5.0%

Primary outcome

Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions
Time frame: Day 1 - Week 36
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions

Results and safety

Results posted to the registry on 5 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Olumacostat Glasaretil Gel, 5.0%	748	431

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

Time frame: Day 1 - Week 36. Number. Unit: Participants

Measure	Olumacostat Glasaretil Gel, 5.0% n = 741
Adverse Events (Mild)	197
Adverse Events (Moderate)	124
Adverse Events (Severe)	18
Adverse Events (Not Reported)	402
Burning/Stinging (None)	518
Burning/Stinging (Mild)	11
Burning/Stinging (Moderate)	2
Burning/Stinging (Severe)	0

Population analysed: Safety Population

Adverse events

Time frame: Baseline to Week 36. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Olumacostat Glasaretil Gel, 5.0%	8 of 741 (1.1%)	281 of 741 (37.9%)	0 of 741

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acne Vulgaris

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Beth Zib study director

Dermira, Inc.

94 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olumacostat Glasaretil Gel, 5.0% in people with Acne Vulgaris, run by Dermira, Inc. at 94 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions (time frame: Day 1 - Week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03127956.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.