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

NCT02431052 | Completed Phase 2 Results

• 1 other identifier: DRM01B-ACN02
• Study Type: interventional
• Target: 420
• Locations: 2 countries
• Sites: 34

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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 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

  Baseline and Week 12

Study Arms (5)

Olumacostat Glasaretil Gel, Vehicle QD

PLACEBO COMPARATOR

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

Other: Vehicle

Olumacostat Glasaretil Gel, Vehicle BID

PLACEBO COMPARATOR

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

Other: Vehicle

Olumacostat Glasaretil Gel, 4.0% QD

EXPERIMENTAL

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

Drug: Olumacostat Glasaretil

Olumacostat Glasaretil Gel, 7.5% QD

EXPERIMENTAL

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

Drug: Olumacostat Glasaretil

Olumacostat Glasaretil Gel, 7.5% BID

EXPERIMENTAL

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

Drug: Olumacostat Glasaretil

Interventions

Olumacostat Glasaretil DRUG

Also known as: DRM01B

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dermira, Inc.: lead

Study Sites (34)

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

T. Joseph Raoof, MD, Inc.

Encino, California, 94136, United States

Location

University Clinical Trials, Inc.

San Diego, California, 92123, United States

Location

Tory Sullivan MD PA

North Miami Beach, Florida, 33162, United States

Location

International Clinical Research - US, LLC

Sanford, Florida, 32771, United States

Location

MOORE Clinical Research, Inc.

Tampa, Florida, 33609, United States

Location

Visions Clinical Research

Wellington, Florida, 33414, United States

Location

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

Location

Lawrence J. Green, MD, LLC

Rockville, Maryland, 20850, United States

Location

Michigan Center for Skin Care Research

Clinton Township, Michigan, 48038, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Las Vegas Dermatology

Las Vegas, Nevada, 89144, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Skin Search of Rochester, Inc.

Rochester, New York, 14623, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

The Skin Wellness Center

Knoxville, Tennessee, 37922, United States

Location

International Clinical Research - Tennessee LLC

Murfreesboro, Tennessee, 37130, United States

Location

DermResearch, Inc

Austin, Texas, 78759, United States

Location

J&S Studies, Inc.

College Station, Texas, 77845, United States

Location

Center for Clinical Studies, LTD. LLP

Houston, Texas, 77004, United States

Location

Suzanne Bruce & Associates, PA. The Center for Skin Research

Houston, Texas, 77056, United States

Location

Suzanne Bruce & Associates, PA. The Center for Skin Research

Katy, Texas, 77494, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

Progressive Clinical Research, PA

San Antonio, Texas, 78229, United States

Location

Dermatology Research Center, Inc.

Salt Lake City, Utah, 84117, United States

Location

The Education & Research Foundation, Inc.

Lynchburg, Virginia, 24501, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

Kirk Barber Research

Calgary, Alberta, T2G1B1, Canada

Location

Enverus Medical Research

Surrey, British Columbia, V3V0C6, Canada

Location

Lynderm Research

Markham, Ontario, L3P1X2, Canada

Location

Windsor Clinical Research, Inc.

Windsor, Ontario, N8W 5L7, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

Centre de Recherche Dermetologique du Quebec Metropolitain (CRDQ)

Québec, G1V 4X7, Canada

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company.

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Beth Zib

  Dermira, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: April 30, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 20, 2021
• Results First Posted: February 26, 2019

Record last verified: 2021-07

Locations

CA (6); US (28)