Acne VulgarisPhase 2NCT02431052
A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris
A Phase 2 study testing Olumacostat Glasaretil in people with Acne Vulgaris, run by Dermira, Inc. at 34 sites in 2 countries.
Trial summary
The objectives of this study are to assess the safety and efficacy DRM01 Topical Gel compared to vehicle in patients with acne vulgaris. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Olumacostat Glasaretil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 34 sitesin 2 countries
- Study dates
- Apr 2015to Apr 2016
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Male or non-pregnant, non-lactating females.
- Age ≥ 18 years.
- Clinical diagnosis of facial acne vulgaris defined as:
- At least 20 inflammatory lesions
- At least 20 non-inflammatory lesions
- 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.
- Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator.
- Abnormal findings on screening ECG, deemed clinically significant, by the Investigator.
- 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.
- Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections, in the opinion of the investigator.
Show all 14Show fewer
- 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 corticosteroids (use of intranasal and inhaled corticosteroids allowed for seasonal allergies and asthma) within 4 weeks prior to Baseline.
- Treatment with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs within 4 weeks prior to Baseline.
- Prescription topical retinoid use on the face within 4 weeks of Baseline (e.g., tretinoin, tazarotene, adapalene).
- Treatment with a new hormonal therapy or dose change to existing hormonal therapy within 12 weeks prior to Baseline. Dose and frequency of use of any hormonal therapy started more than 12 weeks prior to Baseline must remain unchanged throughout the study. Hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills.
- Prior use of androgen receptor blockers (such as spironolactone or flutamide).
- 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 of Baseline.
- Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks or during the study.
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
United States28 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
DermResearch, Inc
Austin, Texas, 78759
Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038
J&S Studies, Inc.
College Station, Texas, 77845
Henry Ford Health System
Detroit, Michigan, 48202
T. Joseph Raoof, MD, Inc.
Encino, California, 94136
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Dermatology Consulting Services
High Point, North Carolina, 27262
Center for Clinical Studies, LTD. LLP
Houston, Texas, 77004
Suzanne Bruce & Associates, PA. The Center for Skin Research
Houston, Texas, 77056
Suzanne Bruce & Associates, PA. The Center for Skin Research
Katy, Texas, 77494
The Skin Wellness Center
Knoxville, Tennessee, 37922
Las Vegas Dermatology
Las Vegas, Nevada, 89144
DermResearch, PLLC
Louisville, Kentucky, 40217
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, 37130
Tory Sullivan MD PA
North Miami Beach, Florida, 33162
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
Skin Search of Rochester, Inc.
Rochester, New York, 14623
Lawrence J. Green, MD, LLC
Rockville, Maryland, 20850
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84117
Progressive Clinical Research, PA
San Antonio, Texas, 78229
University Clinical Trials, Inc.
San Diego, California, 92123
International Clinical Research - US, LLC
Sanford, Florida, 32771
Premier Clinical Research
Spokane, Washington, 99202
MOORE Clinical Research, Inc.
Tampa, Florida, 33609
Visions Clinical Research
Wellington, Florida, 33414
Canada6 sites
Kirk Barber Research
Calgary, Alberta, T2G1B1
Lynderm Research
Markham, Ontario, L3P1X2
Innovaderm Research Inc.
Montreal, Quebec, H2K 4L5
Centre de Recherche Dermetologique du Quebec Metropolitain (CRDQ)
Québec, G1V 4X7
Enverus Medical Research
Surrey, British Columbia, V3V0C6
Windsor Clinical Research, Inc.
Windsor, Ontario, N8W 5L7
About this study
Official title: A Phase 2, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study of DRM01B Topical Gel in Subjects With Acne Vulgaris
The objectives of this study are to assess the safety and efficacy DRM01 Topical Gel compared to vehicle in patients with acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Olumacostat Glasaretil, 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 GlasaretilDrug
Also called DRM01B
VehicleOther
| Study group | Role | What they receive |
|---|---|---|
| Olumacostat Glasaretil Gel, Vehicle QD | Placebo comparator | Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks Receives: Other: Vehicle |
| Olumacostat Glasaretil Gel, Vehicle BID | Placebo comparator | Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks Receives: Other: Vehicle |
| Olumacostat Glasaretil Gel, 4.0% QD | Experimental | Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks Receives: Drug: Olumacostat Glasaretil |
| Olumacostat Glasaretil Gel, 7.5% QD | Experimental | Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks Receives: Drug: Olumacostat Glasaretil |
| Olumacostat Glasaretil Gel, 7.5% BID | Experimental | Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks Receives: Drug: Olumacostat Glasaretil |
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 posted30 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016
- Study completionApr 2016
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 420 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
- NCT02431052
- Sponsor's protocol ID
- DRM01B-ACN02
- Status last verified
- Jul 2021
- First submitted
- 27 Apr 2015
- 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 Phase 2, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study of DRM01B Topical Gel in Subjects With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02431052
- Acronym / sponsor ID
- DRM01B-ACN02
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Dermira, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 30 Apr 2015 (estimated)
- Results
- Posted 26 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 DRM01 Topical Gel compared to vehicle in patients with acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Olumacostat Glasaretil Gel, Vehicle QD | Placebo comparator | Other: VehicleOlumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks |
| Olumacostat Glasaretil Gel, Vehicle BID | Placebo comparator | Other: VehicleOlumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks |
| Olumacostat Glasaretil Gel, 4.0% QD | Experimental | Drug: Olumacostat GlasaretilOlumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks |
| Olumacostat Glasaretil Gel, 7.5% QD | Experimental | Drug: Olumacostat GlasaretilOlumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks |
| Olumacostat Glasaretil Gel, 7.5% BID | Experimental | Drug: Olumacostat GlasaretilOlumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent.
- Male or non-pregnant, non-lactating females.
- Age ≥ 18 years.
- Clinical diagnosis of facial acne vulgaris defined as:
- At least 20 inflammatory lesions
Key exclusion criteria (14 listed)
- Active cystic acne or acne conglobata, acne fulminans, and secondary acne.
- Two or more active nodulocystic lesions.
- Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator.
- Abnormal findings on screening ECG, deemed clinically significant, by the Investigator.
- 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.
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 GlasaretilAlso: DRM01B | Drug | Olumacostat Glasaretil Gel, 4.0% QD, Olumacostat Glasaretil Gel, 7.5% BID, Olumacostat Glasaretil Gel, 7.5% QD |
| Vehicle | Other | Olumacostat Glasaretil Gel, Vehicle BID, Olumacostat Glasaretil Gel, Vehicle QD |
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.
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.
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olumacostat Glasaretil in people with Acne Vulgaris, run by Dermira, Inc. at 34 sites in 2 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 7 inclusion and 14 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 34 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 26 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.