A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

A Randomized, Double-blind, Vehicle Controlled, Efficacy and Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03028363
• Other study ID #: DRM01B-ACN03
• Status: Completed
• Phase: Phase 3
• Start date: December 27, 2016
• Est. completion date: November 28, 2017

Study information

• Verified date: July 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 759
• Est. completion date: November 28, 2017
• Est. primary completion date: November 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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, a-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

• 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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Olumacostat Glasaretil Gel, 5.0%
Gel containing Olumacostat Glasaretil

Other:
• Olumacostat Glasaretil Gel, Vehicle
Vehicle (placebo) gel

Locations

Country	Name	City	State
Australia	Skin & Cancer Foundation Inc.	Carlton	Victoria
Australia	Fremantle Dermatology	Fremantle	Western Australia
Australia	North Eastern Health Specialists	Hectorville	South Australia
Australia	St George Dermatology and Skin Cancer Centre	Kogarah	New South Wales
Australia	Woden Dermatology	Phillip	Australian Capital Territory
Canada	SimcoDerm Medical and Surgical Dermatology Center	Barrie	Ontario
Canada	Institute for Skin Advancement	Calgary	Alberta
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	North Bay Dermatology Centre	North Bay	Ontario
Canada	Research Toronto	Toronto	Ontario
Canada	Windsor Research Inc.	Windsor	Ontario
United States	Anaheim Clinical Trials	Anaheim	California
United States	Arlington Dermatology	Arlington Heights	Illinois
United States	DermResearch	Austin	Texas
United States	Great Lakes Research Group, Inc	Bay City	Michigan
United States	Forefront Dermatology	Carmel	Indiana
United States	J &S Studies, Inc	College Station	Texas
United States	Meridian Clincial Research	Dakota Dunes	South Dakota
United States	Horizons Clinical Research Center, LLC	Denver	Colorado
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Cyn3rgy Research	Gresham	Oregon
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	Dermatology Research Associates	Los Angeles	California
United States	Skin Sciences, PLLC	Louisville	Kentucky
United States	Finlay Medical Research	Miami	Florida
United States	Acne Treatment & Research Center	Morristown	New Jersey
United States	International Clinical Research - Tennessee LLC	Murfreesboro	Tennessee
United States	International Clinical Research-Tennesse LLC	Murfreesboro	Tennessee
United States	Synexus US, LP, dba, Research Across America	Murphy	Texas
United States	Schweiger Dermatology, PLLC	New York	New York
United States	Meridian Clinical Research, LLC	Norfolk	Nebraska
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Meridian Clinical Research	Omaha	Nebraska
United States	Quality Clinical Research Inc	Omaha	Nebraska
United States	Kansas City Dermatology, PA	Overland Park	Kansas
United States	Alliance Dermatology & MOHS Center	Phoenix	Arizona
United States	Health Awareness, Inc	Port Saint Lucie	Florida
United States	Lawrence Jeffrey Green MD, LLC	Rockville	Maryland
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Progressive Clinical Research, PA	San Antonio	Texas
United States	Rady Children's Hospital UCSD Pediatric and Adolescent Derm	San Diego	California
United States	University Clinical Trials Inc.	San Diego	California
United States	International Clinical Research-US, LLC	Sanford	Florida
United States	Dermatology Physicians of CT	Shelton	Connecticut
United States	DermResearchCenter of New York, Inc.	Stony Brook	New York
United States	Lenus Research & Medical Group	Sweetwater	Florida
United States	Mercy Research	Washington	Missouri
United States	Research Institute of the Southeast, LLC	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Dermira, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Baseline and Week 12