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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03073486




Registration number
NCT03073486
Ethics application status
Date submitted
3/03/2017
Date registered
8/03/2017
Date last updated
5/02/2019

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-ACN04
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 - 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 - 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 - 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
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Skin Centre - Benowa
Recruitment hospital [2] 0 0
Premier Specialists - Kogarah
Recruitment hospital [3] 0 0
Sinclair Dermatology - Melbourne
Recruitment hospital [4] 0 0
Burswood Dermatology - Victoria Park
Recruitment hospital [5] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment postcode(s) [1] 0 0
4217 - Benowa
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
3002 - Melbourne
Recruitment postcode(s) [4] 0 0
6100 - Victoria Park
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Canada
State/province [17] 0 0
British Columbia
Country [18] 0 0
Canada
State/province [18] 0 0
Manitoba
Country [19] 0 0
Canada
State/province [19] 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/show/NCT03073486
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
Other publications