Acne VulgarisPhase 3NCT03028363
A 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 49 sites in 3 countries.
Trial 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 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?
- Yes, some participants may receive a placebo
- How many people
- 759 participants
- Where
- 49 sitesin 3 countries
- Study dates
- 27 Dec 2016to 28 Nov 2017
- 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 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
Who cannot join
- 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
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- 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
Trial locations and contacts
49 sites in 3 countries.
49 sites in 3 countries
United States38 sites
Anaheim Clinical Trials
Anaheim, California, 92801
Arlington Dermatology
Arlington Heights, Illinois, 60005
DermResearch
Austin, Texas, 78759
Great Lakes Research Group, Inc
Bay City, Michigan, 48706
Forefront Dermatology
Carmel, Indiana, 46032
J &S Studies, Inc
College Station, Texas, 77845
Meridian Clincial Research
Dakota Dunes, South Dakota, 57049
Horizons Clinical Research Center, LLC
Denver, Colorado, 80220
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Cyn3rgy Research
Gresham, Oregon, 97030
Clinical Partners, LLC
Johnston, Rhode Island, 02919
Dermatology Research Associates
Los Angeles, California, 90045
Skin Sciences, PLLC
Louisville, Kentucky, 40217
Finlay Medical Research
Miami, Florida, 33126
Acne Treatment & Research Center
Morristown, New Jersey, 07960
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, 37130
International Clinical Research-Tennesse LLC
Murfreesboro, Tennessee, 37130
Synexus US, LP, dba, Research Across America
Murphy, Texas, 75094
Schweiger Dermatology, PLLC
New York, New York, 10022
Meridian Clinical Research, LLC
Norfolk, Nebraska, 68701
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
Quality Clinical Research Inc
Omaha, Nebraska, 68114
Meridian Clinical Research
Omaha, Nebraska, 68134
Kansas City Dermatology, PA
Overland Park, Kansas, 66215
Alliance Dermatology & MOHS Center
Phoenix, Arizona, 85032
Health Awareness, Inc
Port Saint Lucie, Florida, 34952
Lawrence Jeffrey Green MD, LLC
Rockville, Maryland, 20850
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
University Clinical Trials Inc.
San Diego, California, 92123
International Clinical Research-US, LLC
Sanford, Florida, 32771
Dermatology Physicians of CT
Shelton, Connecticut, 06484
DermResearchCenter of New York, Inc.
Stony Brook, New York, 11790
Lenus Research & Medical Group
Sweetwater, Florida, 33172
Mercy Research
Washington, Missouri, 63090
Research Institute of the Southeast, LLC
West Palm Beach, Florida, 33401
Canada6 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
North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7
Research Toronto
Toronto, Ontario, M4W 2N2
Windsor Research Inc.
Windsor, Ontario, N8W 5L7
Australia5 sites
Skin & Cancer Foundation Inc.
Carlton, Victoria, 3053
Fremantle Dermatology
Fremantle, Western Australia, 6160
North Eastern Health Specialists
Hectorville, South Australia, 5073
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, 2217
Woden Dermatology
Phillip, Australian Capital Territory, 2606
About this study
Official title: A Randomized, Double-blind, Vehicle Controlled, Efficacy and Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil Gel compared to vehicle in patients with acne vulgaris
- Conditions
- Acne Vulgaris
- Being tested
- Olumacostat Glasaretil Gel, 5.0%, Olumacostat Glasaretil Gel, Vehicle
- 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 DRM01
Gel containing Olumacostat Glasaretil
Olumacostat Glasaretil Gel, VehicleOther
Vehicle (placebo) gel
| Study group | Role | What they receive |
|---|---|---|
| Olumacostat Glasaretil Gel, 5.0% | Experimental | Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks Receives: Drug: Olumacostat Glasaretil Gel, 5.0% |
| Olumacostat Glasaretil Gel, Vehicle | Placebo comparator | Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks Receives: Other: Olumacostat Glasaretil Gel, Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12
Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12
Measured: Baseline and Week 12
Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12
Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12
Measured: 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
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
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start27 Dec 2016
- Primary completion28 Nov 2017
- Study completion28 Nov 2017
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 759 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermira, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beth Zib, Study director, Dermira, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028363
- Sponsor's protocol ID
- DRM01B-ACN03
- Status last verified
- Jul 2021
- First submitted
- 19 Jan 2017
- Last updated
- 20 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- A Randomized, Double-blind, Vehicle Controlled, Efficacy and Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT03028363
- Acronym / sponsor ID
- DRM01B-ACN03
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 759 participants (actual)
- Lead sponsor
- Dermira, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Dec 2016 (actual)
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 23 Jan 2017 (estimated)
- 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 objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil Gel compared to vehicle in patients with acne vulgaris
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| 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 for 12 weeks |
| Olumacostat Glasaretil Gel, Vehicle | Placebo comparator | Other: Olumacostat Glasaretil Gel, VehicleOlumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent and, for subjects under legal adult age, signed assent
- Age ≥ 9 years
- Clinical diagnosis of facial acne vulgaris defined as:
Key exclusion criteria (10 listed)
- 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
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: DRM01Gel containing Olumacostat Glasaretil | Drug | Olumacostat Glasaretil Gel, 5.0% |
| Olumacostat Glasaretil Gel, VehicleVehicle (placebo) gel | Other | Olumacostat Glasaretil Gel, Vehicle |
Primary outcome
Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12
Time frame: Baseline and Week 12
Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12
Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12
Time frame: Baseline and Week 12
Mean absolute change in acne lesion counts (non-inflammatory) from baseline to 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
Time frame: 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 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
Results and safety
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.
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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.
49 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 49 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 6 inclusion and 10 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 49 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. Some participants in this study may receive a placebo. 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?
Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 (time frame: Baseline and Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.