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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.

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Olumacostat Glasaretil Other: Vehicle Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study of DRM01B Topical Gel in Subjects With Acne Vulgaris
Study Start Date : April 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Placebo Comparator: Olumacostat Glasaretil Gel, Vehicle QD
Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks
Other: Vehicle
Placebo Comparator: Olumacostat Glasaretil Gel, Vehicle BID
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Other: Vehicle
Experimental: Olumacostat Glasaretil Gel, 4.0% QD
Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks
Drug: Olumacostat Glasaretil
Other Name: DRM01B

Experimental: Olumacostat Glasaretil Gel, 7.5% QD
Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks
Drug: Olumacostat Glasaretil
Other Name: DRM01B

Experimental: Olumacostat Glasaretil Gel, 7.5% BID
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
Drug: Olumacostat Glasaretil
Other Name: DRM01B




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02431052


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Sponsors and Collaborators
Dermira, Inc.
Investigators
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Study Director: Beth Zib Dermira, Inc.

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Responsible Party: Dermira, Inc.
ClinicalTrials.gov Identifier: NCT02431052     History of Changes
Other Study ID Numbers: DRM01B-ACN02
First Posted: April 30, 2015    Key Record Dates
Results First Posted: February 26, 2019
Last Update Posted: February 26, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases