search
Back to results

A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Olumacostat Glasaretil
Vehicle
Sponsored by
Dermira, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • Coastal Clinical Research, Inc.
  • T. Joseph Raoof, MD, Inc.
  • University Clinical Trials, Inc.
  • Tory Sullivan MD PA
  • International Clinical Research - US, LLC
  • MOORE Clinical Research, Inc.
  • Visions Clinical Research
  • DermResearch, PLLC
  • Lawrence J. Green, MD, LLC
  • Michigan Center for Skin Care Research
  • Henry Ford Health System
  • Minnesota Clinical Study Center
  • Las Vegas Dermatology
  • Academic Dermatology Associates
  • Skin Search of Rochester, Inc.
  • Dermatology Consulting Services
  • The Skin Wellness Center
  • International Clinical Research - Tennessee LLC
  • DermResearch, Inc
  • J&S Studies, Inc.
  • Center for Clinical Studies, LTD. LLP
  • Suzanne Bruce & Associates, PA. The Center for Skin Research
  • Suzanne Bruce & Associates, PA. The Center for Skin Research
  • Austin Institute for Clinical Research
  • Progressive Clinical Research, PA
  • Dermatology Research Center, Inc.
  • The Education & Research Foundation, Inc.
  • Premier Clinical Research
  • Kirk Barber Research
  • Enverus Medical Research
  • Lynderm Research
  • Windsor Clinical Research, Inc.
  • Innovaderm Research Inc.
  • Centre de Recherche Dermetologique du Quebec Metropolitain (CRDQ)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Olumacostat Glasaretil Gel, Vehicle QD

Olumacostat Glasaretil Gel, Vehicle BID

Olumacostat Glasaretil Gel, 4.0% QD

Olumacostat Glasaretil Gel, 7.5% QD

Olumacostat Glasaretil Gel, 7.5% BID

Arm Description

Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks

Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks

Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks

Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks

Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
April 27, 2015
Last Updated
July 16, 2021
Sponsor
Dermira, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02431052
Brief Title
A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris
Official Title
A Phase 2, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study of DRM01B Topical Gel in Subjects With Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dermira, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objectives of this study are to assess the safety and efficacy DRM01 Topical Gel compared to vehicle in patients with acne vulgaris.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olumacostat Glasaretil Gel, Vehicle QD
Arm Type
Placebo Comparator
Arm Description
Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks
Arm Title
Olumacostat Glasaretil Gel, Vehicle BID
Arm Type
Placebo Comparator
Arm Description
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Arm Title
Olumacostat Glasaretil Gel, 4.0% QD
Arm Type
Experimental
Arm Description
Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks
Arm Title
Olumacostat Glasaretil Gel, 7.5% QD
Arm Type
Experimental
Arm Description
Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks
Arm Title
Olumacostat Glasaretil Gel, 7.5% BID
Arm Type
Experimental
Arm Description
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Olumacostat Glasaretil
Other Intervention Name(s)
DRM01B
Intervention Type
Other
Intervention Name(s)
Vehicle
Primary Outcome Measure Information:
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth Zib
Organizational Affiliation
Dermira, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Coastal Clinical Research, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
T. Joseph Raoof, MD, Inc.
City
Encino
State/Province
California
ZIP/Postal Code
94136
Country
United States
Facility Name
University Clinical Trials, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Tory Sullivan MD PA
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
International Clinical Research - US, LLC
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
MOORE Clinical Research, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Visions Clinical Research
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
DermResearch, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Lawrence J. Green, MD, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Michigan Center for Skin Care Research
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Las Vegas Dermatology
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Skin Search of Rochester, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Dermatology Consulting Services
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
The Skin Wellness Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
International Clinical Research - Tennessee LLC
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
DermResearch, Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J&S Studies, Inc.
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Center for Clinical Studies, LTD. LLP
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Suzanne Bruce & Associates, PA. The Center for Skin Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Suzanne Bruce & Associates, PA. The Center for Skin Research
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Facility Name
Austin Institute for Clinical Research
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Progressive Clinical Research, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Dermatology Research Center, Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
The Education & Research Foundation, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Kirk Barber Research
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2G1B1
Country
Canada
Facility Name
Enverus Medical Research
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V0C6
Country
Canada
Facility Name
Lynderm Research
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P1X2
Country
Canada
Facility Name
Windsor Clinical Research, Inc.
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
Facility Name
Innovaderm Research Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
Facility Name
Centre de Recherche Dermetologique du Quebec Metropolitain (CRDQ)
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris

We'll reach out to this number within 24 hrs