Clinical trial NCT03073486: A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Official title: A Randomized, Double-blind, Vehicle Controlled, Efficacy and Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-03-08
Enrollment: 744
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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, α-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

Primary outcomes:
measure: Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12
timeFrame: Baseline and Week 12
measure: Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12
timeFrame: Baseline and Week 12
measure: 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
timeFrame: Baseline and Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Guntersville
country: United States
facility: Avant Research Associates, LLC
state: Alabama
city: Glendale
country: United States
facility: Advanced Research Associates
state: Arizona
city: Bryant
country: United States
facility: Dermatology Trial Associates
state: Arkansas
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center
state: Arkansas
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Fullerton
country: United States
facility: Advanced Skincare Surgery & MedCenter
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: San Diego
country: United States
facility: TCR Medical Corporation
state: California
city: Santa Rosa
country: United States
facility: Radiant Research, Inc.
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Aventura
country: United States
facility: Center for Clincial and Cosmetic Research
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Centers Research & Education
state: Florida
city: Hialeah
country: United States
facility: Aby's New GEneration Research Inc.
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Miami
country: United States
facility: Floridian Research Institute
state: Florida
city: Pembroke Pines
country: United States
facility: Pioneer Clinical Research
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research, Inc.
state: Florida
city: Tampa
country: United States
facility: MOORE Clinical Research, Inc
state: Florida
city: Wellington
country: United States
facility: Visions Clinical Research
state: Florida
city: Marietta
country: United States
facility: Marietta Dermatology Clinical Research, Inc.
state: Georgia
city: Metairie
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Medical Center, New Center One
state: Michigan
city: Las Vegas
country: United States
facility: JDR Dermatology Research, LLC
state: Nevada
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc.
state: New York
city: Cincinnati
country: United States
facility: Sterling Research Group
state: Ohio
city: Knoxville
country: United States
facility: The Skin Wellness Center
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Beaumont
country: United States
facility: Avant Research Associates
state: Texas
city: Dallas
country: United States
facility: Synexus US, LP, dba, Research Across America
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, P.A. The Center for Skin
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc
state: Texas
city: Sugar Land
country: United States
facility: Houston Center for Clinical Research
state: Texas
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc.
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Benowa
country: Australia
facility: The Skin Centre
city: Kogarah
country: Australia
facility: Premier Specialists
city: Melbourne
country: Australia
facility: Sinclair Dermatology
city: Victoria Park
country: Australia
facility: Burswood Dermatology
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research
state: Ontario
Study officials:
affiliation: Dermira, Inc.
name: Beth Zib
role: STUDY_DIRECTOR
References: