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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03028363




Registration number
NCT03028363
Ethics application status
Date submitted
19/01/2017
Date registered
23/01/2017
Date last updated
20/07/2021

Titles & IDs
Public title
A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Scientific title
A Randomized, Double-blind, Vehicle Controlled, Efficacy and Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Secondary ID [1] 0 0
DRM01B-ACN03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acne Vulgaris 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Olumacostat Glasaretil Gel, 5.0%
Other interventions - Olumacostat Glasaretil Gel, Vehicle

Experimental: Olumacostat Glasaretil Gel, 5.0% - Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks

Placebo comparator: Olumacostat Glasaretil Gel, Vehicle - Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks


Treatment: Drugs: Olumacostat Glasaretil Gel, 5.0%
Gel containing Olumacostat Glasaretil

Other interventions: Olumacostat Glasaretil Gel, Vehicle
Vehicle (placebo) gel
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12
Timepoint [1] 0 0
Baseline and Week 12
Primary outcome [2] 0 0
Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12
Timepoint [2] 0 0
Baseline and Week 12
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
Baseline and Week 12

Eligibility
Key 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
Minimum age
9 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/11/2017
Sample size
Target
Accrual to date
Final
759
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Woden Dermatology - Phillip
Recruitment hospital [2] 0 0
St George Dermatology and Skin Cancer Centre - Kogarah
Recruitment hospital [3] 0 0
North Eastern Health Specialists - Hectorville
Recruitment hospital [4] 0 0
Skin & Cancer Foundation Inc. - Carlton
Recruitment hospital [5] 0 0
Fremantle Dermatology - Fremantle
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
5073 - Hectorville
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment postcode(s) [5] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Maryland
Country [11] 0 0
United States of America
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Michigan
Country [12] 0 0
United States of America
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Minnesota
Country [13] 0 0
United States of America
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Missouri
Country [14] 0 0
United States of America
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Nebraska
Country [15] 0 0
United States of America
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New Jersey
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United States of America
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New York
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United States of America
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Oregon
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United States of America
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Rhode Island
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United States of America
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South Dakota
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Dermira, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT03028363
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Beth Zib
Address 0 0
Dermira, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03028363