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A Safety, Tolerability and Preliminary Efficacy Study of DRM01B Topical Gel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01936324
Recruitment Status : Completed
First Posted : September 6, 2013
Results First Posted : May 10, 2019
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Dermira, Inc.

Tracking Information
First Submitted Date  ICMJE September 3, 2013
First Posted Date  ICMJE September 6, 2013
Results First Submitted Date  ICMJE January 31, 2019
Results First Posted Date  ICMJE May 10, 2019
Last Update Posted Date May 27, 2019
Study Start Date  ICMJE August 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 in Phase 2a [ Time Frame: Baseline and Week 12 ]
    Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12 in Phase 2a
  • Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 in Phase 2a [ Time Frame: Baseline and Week 12 ]
    Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12 in Phase 2a
  • Percentage of Subjects Who Achieved ≥ 2-grade Improvement in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 in Phase 2a [ Time Frame: Baseline and Week 12 ]
    Percentage of subjects who achieved ≥ 2-grade improvement in the investigator global assessment of acne (IGA) from baseline to Week 12 in Phase 2a 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: September 5, 2013)
Change from baseline in acne lesion count [ Time Frame: Week 4, 12 and 16 ]
Change History Complete list of historical versions of study NCT01936324 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
Change from baseline in investigator global assessment [ Time Frame: Week 4, 12, and 16 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety, Tolerability and Preliminary Efficacy Study of DRM01B Topical Gel
Official Title  ICMJE A Study of the Safety, Tolerability and Preliminary Efficacy of DRM01B Topical Gel in Healthy Volunteers and Subjects With Acne Vulgaris
Brief Summary

This is a Phase 1/2a study.

The purpose of Phase 1 was to evaluate the safety and tolerability of DRM01B Topical Gel in 6 healthy volunteers.

The purpose of Phase 2a was to assess the safety, tolerability and preliminary efficacy of DRM01B Topical Gel compared to vehicle in subjects with acne vulgaris on the face.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
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 Gel, 7.5%
    Gel containing Olumacostat Glasaretil
    Other Name: DRM01
  • Other: Olumacostat Glasaretil Gel, Vehicle
    Vehicle (placebo) gel
Study Arms  ICMJE
  • Experimental: Phase 1
    Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 7 days in healthy volunteers
    Intervention: Drug: Olumacostat Glasaretil Gel, 7.5%
  • Experimental: Phase 2a
    Olumacostat Glasaretil Gel, 7.5%, or Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
    Interventions:
    • Drug: Olumacostat Glasaretil Gel, 7.5%
    • Other: Olumacostat Glasaretil Gel, Vehicle
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: January 31, 2019)
114
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2013)
106
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Phase 1 Inclusion Criteria

  1. Signed informed consent
  2. Willing to comply with the requirements of the protocol
  3. Males or non-pregnant, non-lactating females
  4. Age ≥ 18 years
  5. Was in good health and free from any clinically significant disease, as determined by the investigator
  6. If female and of childbearing potential, was willing to use an accepted method of birth control during study participation and for 30 days after the last application of study drug. Females were considered to be of childbearing potential unless they had been surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation), had been diagnosed as infertile, had a same-sex partner or vasectomized male partner, were postmenopausal for at least 1 year, or were abstinent. Acceptable methods of birth control were defined as: abstinence, oral contraceptives, contraceptive patches/implants; Depo-Provera®, double barrier methods (e.g., condom and spermicide) or an intrauterine device (IUD). The birth control method must have been stable/unchanged for 30 days prior to baseline.
  7. If male, was vasectomized or agreed to use an accepted method of birth control with female partner during study participation and for 30 days after the last application of study drug.

Phase 1 Exclusion Criteria

  1. Females who were pregnant, planning to become pregnant during the course of the study, or were breast-feeding
  2. Had a known hypersensitivity to DRM01B or its excipients
  3. Had any skin condition that may have interfered with the safety evaluations during the study
  4. Had a clinical chemistry or hematology laboratory value at screening that was considered clinically significant, in the opinion of the investigator
  5. Participated in an investigational drug study within 30 days prior to screening
  6. Were considered a poor medical risk because of other systemic diseases or active uncontrolled infections, in the opinion of the investigator. Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.

Phase 2a Inclusion Criteria

  1. Signed informed consent
  2. Willing to comply with the requirements of the protocol
  3. Male or non-pregnant, non-lactating females
  4. Age ≥ 18 years
  5. If female and of childbearing potential, was willing to use an accepted method of birth control during study participation and for 30 days after the last study drug application. Females were considered to be of childbearing potential unless surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation), had been diagnosed as infertile, had same sex partner or vasectomized male partner, or were postmenopausal for at least 1 year. Acceptable methods of birth control were defined as: abstinence, oral contraceptives, contraceptive patches/implants; Depo-Provera®, double barrier methods (e.g., condom and spermicide) or an IUD. The birth control method must have been stable/unchanged for 12 weeks prior to baseline and must have remained unchanged during study participation.
  6. If male, was vasectomized or agreed to use an accepted method of birth control with female partner during study participation and for 30 days after the last study drug application.
  7. Subjects were in good health and free from any disease that, in the opinion of the investigator, would have put the subject at risk during participation in the study.
  8. Clinical diagnosis of facial acne vulgaris defined as:

    • At least 20 inflammatory lesions
    • At least 20 noninflammatory lesions
    • IGA of 3 or greater
  9. Willing to refrain from using any treatments, other than the investigational product, including antibiotics, for acne present on the face. Topical acne treatments that did not have significant or measurable systemic absorption (e.g., benzoyl peroxide, salicylic acid) were allowed for treatment of acne of the back, shoulders, and chest only.

Phase 2a Exclusion Criteria

  1. Females who were pregnant, planning to become pregnant during the course of the study, or breast-feeding
  2. Had a known hypersensitivity to DRM01B or its excipients
  3. Had any skin condition that may have interfered with evaluation of safety or acne vulgaris (e.g., rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne or folliculitis)
  4. Had excessive facial hair that would have interfered with diagnosis or assessment of acne vulgaris
  5. Had excessive sun exposure, in the opinion of the investigator, or use of tanning booths
  6. Had active cystic acne or acne conglobata, acne fulminans, and secondary acne
  7. Had 2 or more active nodular lesions
  8. Had a clinical chemistry or hematology laboratory value at screening that was considered clinically significant, in the opinion of the investigator
  9. Participated in an investigational drug study within 30 days prior to screening
  10. Subjects who were a poor medical risk because of other systemic diseases or active uncontrolled infections, in the opinion of the investigator
  11. Any other condition that, in the judgment of the investigator, would have put the subject at unacceptable risk during participation in the study
  12. Treatment with over-the-counter (OTC) 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
  13. Treatment with systemic corticosteroids within 4 weeks prior to baseline (Note: use of intranasal and inhaled corticosteroids was allowed for seasonal allergies and asthma)
  14. Treatment with systemic antibiotics, systemic anti-acne drugs, or systemic anti-inflammatory drugs within 4 weeks prior to baseline
  15. Prescription topical retinoid use on the face within 4 weeks of baseline (e.g., tretinoin, tazarotene, adapalene).
  16. Treatment with a new hormonal therapy or dose change to an existing hormonal therapy within 12 weeks prior to baseline. The dose and frequency of use of any hormonal therapy started more than 12 weeks prior to baseline must have remained unchanged throughout the study. Hormonal therapies included, but were not limited to, estrogenic and progestational agents, such as birth control pills.
  17. Prior use of androgen receptor blockers (such as spironolactone or flutamide)
  18. 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
  19. 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 Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01936324
Other Study ID Numbers  ICMJE DRM01B-ACN01
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: Janice Drew Dermira, Inc.
PRS Account Dermira, Inc.
Verification Date May 2019

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