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A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT03271021
Recruitment Status : Completed
First Posted : September 1, 2017
Results First Posted : February 21, 2020
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Vyne Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE August 30, 2017
First Posted Date  ICMJE September 1, 2017
Results First Submitted Date  ICMJE January 16, 2020
Results First Posted Date  ICMJE February 21, 2020
Last Update Posted Date March 9, 2020
Actual Study Start Date  ICMJE July 17, 2017
Actual Primary Completion Date September 4, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2020)
  • The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12. [ Time Frame: 12 weeks ]
    A decrease in the inflammatory lesion count from Baseline to Week 12.
  • Investigator Global Assessment (IGA) Treatment Success (Dichotomized as Yes/no) at Week 12, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2017)
  • The absolute change from Baseline in the inflammatory lesion count at Week 12. [ Time Frame: 12 weeks ]
  • Severity of acne vulgaris assessed by Investigator Global Assessment (IGA) [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2020)
  • The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12 [ Time Frame: 12 weeks ]
  • The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9 [ Time Frame: 9 weeks ]
  • The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6 [ Time Frame: 6 weeks ]
  • IGA Treatment Success (Dichotomized as Yes/no) at Week 6, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 6 [ Time Frame: 6 weeks ]
  • IGA Treatment Success (Dichotomized as Yes/no) at Week 9, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 9 [ Time Frame: 9 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2017)
  • Absolute Change from baseline in the inflammatory lesion count [ Time Frame: 6 weeks ]
  • Absolute Change from baseline in IGA evaluation [ Time Frame: 6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris
Official Title  ICMJE A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)
Brief Summary A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)
Detailed Description

This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy over 12 weeks of FMX101 topical foam containing 4% minocycline compared to vehicle in the treatment of subjects with moderate-to-severe facial acne vulgaris. Qualified subjects will be randomized to receive 1 of the following 2 treatments:

  • FMX101 4% minocycline foam
  • Vehicle foam
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: FMX101
    FMX101, 4% minocycline foam
  • Drug: Vehicle Foam
    Vehicle Foam
Study Arms  ICMJE
  • Experimental: FMX101, 4% minocycline foam
    FMX101, 4% minocycline foam applied topically once daily for 12 weeks
    Intervention: Drug: FMX101
  • Placebo Comparator: Vehicle foam
    Vehicle foam applied topically once daily for 12 weeks
    Intervention: Drug: Vehicle Foam
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 16, 2020)
1488
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2017)
1500
Actual Study Completion Date  ICMJE September 4, 2018
Actual Primary Completion Date September 4, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Has facial acne vulgaris with:

    1. 20 to 50 inflammatory lesions (papules, pustules, and nodules)
    2. 25 to 100 non-inflammatory lesions (open and closed comedones)
    3. No more than 2 nodules on the face
    4. IGA score of moderate (3) to severe (4)
  2. Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin Cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study.

Exclusion Criteria:

  1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.
  2. Sunburn on the face.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years and older   (Child, 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03271021
Other Study ID Numbers  ICMJE FX2017-22
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vyne Therapeutics Inc.
Study Sponsor  ICMJE Vyne Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vyne Therapeutics Inc.
Verification Date February 2020

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