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A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT02431052
Recruitment Status : Completed
First Posted : April 30, 2015
Results First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Dermira, Inc.

Tracking Information
First Submitted Date  ICMJE April 27, 2015
First Posted Date  ICMJE April 30, 2015
Results First Submitted Date  ICMJE January 31, 2019
Results First Posted Date  ICMJE February 26, 2019
Last Update Posted Date February 26, 2019
Study Start Date  ICMJE April 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2019)
  • Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]
    Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12
  • Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]
    Mean absolute change in acne lesion counts (non-inflammatory) 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 [ Time Frame: Baseline and 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
    1. - Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion
    2. - Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions)
    3. - 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
    4. - Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2015)
Absolute change in lesion counts (inflammatory and non-inflammatory) from baseline and a minimum 2-grade improvement from baseline in Investigator's Global Assessment (IGA) score [ Time Frame: Week 12 ]
Change History Complete list of historical versions of study NCT02431052 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2015)
The percent change from baseline in inflammatory and non-inflammatory lesion counts [ Time Frame: Week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris
Official Title  ICMJE A Phase 2, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study of DRM01B Topical Gel in Subjects With Acne Vulgaris
Brief Summary The objectives of this study are to assess the safety and efficacy DRM01 Topical Gel compared to vehicle in patients with acne vulgaris.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Olumacostat Glasaretil
    Other Name: DRM01B
  • Other: Vehicle
Study Arms  ICMJE
  • Placebo Comparator: Olumacostat Glasaretil Gel, Vehicle QD
    Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks
    Intervention: Other: Vehicle
  • Placebo Comparator: Olumacostat Glasaretil Gel, Vehicle BID
    Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
    Intervention: Other: Vehicle
  • Experimental: Olumacostat Glasaretil Gel, 4.0% QD
    Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks
    Intervention: Drug: Olumacostat Glasaretil
  • Experimental: Olumacostat Glasaretil Gel, 7.5% QD
    Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks
    Intervention: Drug: Olumacostat Glasaretil
  • Experimental: Olumacostat Glasaretil Gel, 7.5% BID
    Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
    Intervention: Drug: Olumacostat Glasaretil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2016)
420
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2015)
400
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed informed consent.
  • Male or non-pregnant, non-lactating females.
  • Age ≥ 18 years.
  • Clinical diagnosis of facial acne vulgaris defined as:
  • At least 20 inflammatory lesions
  • At least 20 non-inflammatory lesions
  • 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.
  • Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator.
  • Abnormal findings on screening ECG, deemed clinically significant, by the Investigator.
  • 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.
  • Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections, in the opinion of the investigator.
  • 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 corticosteroids (use of intranasal and inhaled corticosteroids allowed for seasonal allergies and asthma) within 4 weeks prior to Baseline.
  • Treatment with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs within 4 weeks prior to Baseline.
  • Prescription topical retinoid use on the face within 4 weeks of Baseline (e.g., tretinoin, tazarotene, adapalene).
  • Treatment with a new hormonal therapy or dose change to existing hormonal therapy within 12 weeks prior to Baseline. Dose and frequency of use of any hormonal therapy started more than 12 weeks prior to Baseline must remain unchanged throughout the study. Hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills.
  • Prior use of androgen receptor blockers (such as spironolactone or flutamide).
  • 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 of Baseline.
  • Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks or during the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02431052
Other Study ID Numbers  ICMJE DRM01B-ACN02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dermira, Inc.
Study Sponsor  ICMJE Dermira, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Beth Zib Dermira, Inc.
PRS Account Dermira, Inc.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP