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: NCT03073486
• Other study ID #: DRM01B-ACN04
• Status: Completed
• Phase: Phase 3
• Start date: February 6, 2017
• Est. completion date: December 21, 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: 744
• Est. completion date: December 21, 2017
• Est. primary completion date: December 21, 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	The Skin Centre	Benowa
Australia	Premier Specialists	Kogarah
Australia	Sinclair Dermatology	Melbourne
Australia	Burswood Dermatology	Victoria Park
Australia	Veracity Clinical Research	Woolloongabba
Canada	DermEdge Research	Mississauga	Ontario
Canada	The Centre for Dermatology	Richmond Hill	Ontario
Canada	Enverus Medical Research	Surrey	British Columbia
Canada	XLR8 Medical Research	Windsor	Ontario
Canada	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba
United States	Center for Clincial and Cosmetic Research	Aventura	Florida
United States	Avant Research Associates	Beaumont	Texas
United States	Alpine Clinical Research Center	Boulder	Colorado
United States	Dermatology Trial Associates	Bryant	Arkansas
United States	Sterling Research Group	Cincinnati	Ohio
United States	Florida Academic Centers Research & Education	Coral Gables	Florida
United States	Synexus US, LP, dba, Research Across America	Dallas	Texas
United States	Henry Ford Medical Center, New Center One	Detroit	Michigan
United States	Center for Dermatology Clinical Research, Inc.	Fremont	California
United States	Advanced Skincare Surgery & MedCenter	Fullerton	California
United States	Advanced Research Associates	Glendale	Arizona
United States	Avant Research Associates, LLC	Guntersville	Alabama
United States	Aby's New GEneration Research Inc.	Hialeah	Florida
United States	Suzanne Bruce and Associates, P.A. The Center for Skin	Houston	Texas
United States	Health Awareness, Inc.	Jupiter	Florida
United States	The Skin Wellness Center	Knoxville	Tennessee
United States	JDR Dermatology Research, LLC	Las Vegas	Nevada
United States	The Education & Research Foundation, Inc.	Lynchburg	Virginia
United States	Marietta Dermatology Clinical Research, Inc.	Marietta	Georgia
United States	Clinical Trials Management, LLC	Metairie	Louisiana
United States	Floridian Research Institute	Miami	Florida
United States	Clinical Research Associates, Inc.	Nashville	Tennessee
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	DelRicht Research	New Orleans	Louisiana
United States	Pioneer Clinical Research	Pembroke Pines	Florida
United States	Austin Institute for Clinical Research, Inc	Pflugerville	Texas
United States	Radiant Research, Inc.	Pinellas Park	Florida
United States	Skin Search of Rochester, Inc.	Rochester	New York
United States	Northwest Arkansas Clinical Trials Center	Rogers	Arkansas
United States	Northern California Research	Sacramento	California
United States	TCR Medical Corporation	San Diego	California
United States	Radiant Research, Inc.	Santa Rosa	California
United States	Premier Clinical Research	Spokane	Washington
United States	Houston Center for Clinical Research	Sugar Land	Texas
United States	MOORE Clinical Research, Inc	Tampa	Florida
United States	Visions Clinical Research	Wellington	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