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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03127956




Registration number
NCT03127956
Ethics application status
Date submitted
17/04/2017
Date registered
25/04/2017
Date last updated
20/07/2021

Titles & IDs
Public title
A Long-term Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Scientific title
An Open-Label Study Assessing Long-Term Safety of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Secondary ID [1] 0 0
DRM01B-ACN05
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%

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


Treatment: Drugs: Olumacostat Glasaretil Gel, 5.0%
Gel containing Olumacostat Glasaretil
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions
Timepoint [1] 0 0
Day 1 - Week 36

Eligibility
Key inclusion criteria
- Signed informed consent or assent (for subjects under legal adult age)

- Completed Week 12 visit of either DRM01B-ACN03 or DRM01B-ACN04 studies.

- Willing to comply with the protocol. Subjects under legal adult age will be assessed
by the investigator as to their ability to comply with the protocol

- Willing to refrain from using any treatments on the face for acne vulgaris, other than
the investigational product, including topical or systemic antibiotics.
Minimum age
9 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Abnormal clinically significant findings on physical exam, vital signs or ECG at Week
12 visit of either the DRM01-ACN03 or DMR01-ACN04 studies that would make further
treatment with Olumacostat Glasaretil Gel contraindicated, as determined by the
Investigator

- Any other condition which, in the judgment of the investigator, would put the subject
at unacceptable risk for participation in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
21/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/04/2018
Sample size
Target
Accrual to date
Final
748
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Woden Dermatology - Phillip
Recruitment hospital [2] 0 0
Premier Specialists - Kogarah
Recruitment hospital [3] 0 0
St George Dermatology and Skin Cancer Centre - Kogarah
Recruitment hospital [4] 0 0
The Skin Centre - Benowa
Recruitment hospital [5] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [6] 0 0
North Eastern Health Specialists - Hectorville
Recruitment hospital [7] 0 0
Skin & Cancer Foundation Inc. - Carlton
Recruitment hospital [8] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [9] 0 0
Fremantle Dermatology - Fremantle
Recruitment hospital [10] 0 0
Burswood Dermatology - Victoria Park
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4217 - Benowa
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5073 - Hectorville
Recruitment postcode(s) [6] 0 0
3053 - Carlton
Recruitment postcode(s) [7] 0 0
3002 - East Melbourne
Recruitment postcode(s) [8] 0 0
6160 - Fremantle
Recruitment postcode(s) [9] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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Arkansas
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United States of America
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California
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Colorado
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Connecticut
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Florida
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Georgia
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United States of America
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Maryland
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Michigan
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Minnesota
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Missouri
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Nebraska
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Nevada
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New Jersey
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New York
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Ohio
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Oregon
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Rhode Island
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South Dakota
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Tennessee
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Texas
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Virginia
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Washington
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Canada
State/province [30] 0 0
Alberta
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Canada
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British Columbia
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Canada
State/province [32] 0 0
Manitoba
Country [33] 0 0
Canada
State/province [33] 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 objective of this study is to assess the long-term safety of Olumacostat Glasaretil gel,
5.0% in patients with acne vulgaris
Trial website
https://clinicaltrials.gov/ct2/show/NCT03127956
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT03127956