Clinical trial NCT03028363: 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: 2017-01-23
Enrollment: 759
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: Phoenix
country: United States
facility: Alliance Dermatology & MOHS Center
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital UCSD Pediatric and Adolescent Derm
state: California
city: San Diego
country: United States
facility: University Clinical Trials Inc.
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center, LLC
state: Colorado
city: Shelton
country: United States
facility: Dermatology Physicians of CT
state: Connecticut
city: Miami
country: United States
facility: Finlay Medical Research
state: Florida
city: Port Saint Lucie
country: United States
facility: Health Awareness, Inc
state: Florida
city: Sanford
country: United States
facility: International Clinical Research-US, LLC
state: Florida
city: Sweetwater
country: United States
facility: Lenus Research & Medical Group
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast, LLC
state: Florida
city: Arlington Heights
country: United States
facility: Arlington Dermatology
state: Illinois
city: Carmel
country: United States
facility: Forefront Dermatology
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Dermatology, PA
state: Kansas
city: Louisville
country: United States
facility: Skin Sciences, PLLC
state: Kentucky
city: Rockville
country: United States
facility: Lawrence Jeffrey Green MD, LLC
state: Maryland
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Washington
country: United States
facility: Mercy Research
state: Missouri
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research Inc
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Morristown
country: United States
facility: Acne Treatment & Research Center
state: New Jersey
city: New York
country: United States
facility: Schweiger Dermatology, PLLC
state: New York
city: Stony Brook
country: United States
facility: DermResearchCenter of New York, Inc.
state: New York
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Dakota Dunes
country: United States
facility: Meridian Clincial Research
state: South Dakota
city: Murfreesboro
country: United States
facility: International Clinical Research - Tennessee LLC
state: Tennessee
city: Murfreesboro
country: United States
facility: International Clinical Research-Tennesse LLC
state: Tennessee
city: Austin
country: United States
facility: DermResearch
state: Texas
city: College Station
country: United States
facility: J &S Studies, Inc
state: Texas
city: Murphy
country: United States
facility: Synexus US, LP, dba, Research Across America
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research, PA
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Phillip
country: Australia
facility: Woden Dermatology
state: Australian Capital Territory
city: Kogarah
country: Australia
facility: St George Dermatology and Skin Cancer Centre
state: New South Wales
city: Hectorville
country: Australia
facility: North Eastern Health Specialists
state: South Australia
city: Carlton
country: Australia
facility: Skin & Cancer Foundation Inc.
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Dermatology
state: Western Australia
city: Calgary
country: Canada
facility: Institute for Skin Advancement
state: Alberta
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Windsor
country: Canada
facility: Windsor Research Inc.
state: Ontario
Study officials:
affiliation: Dermira, Inc.
name: Beth Zib
role: STUDY_DIRECTOR
References: