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A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne

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: NCT02815280
Recruitment Status : Completed
First Posted : June 28, 2016
Results First Posted : November 24, 2020
Last Update Posted : January 18, 2022
Sponsor:
Information provided by (Responsible Party):
Vyne Therapeutics Inc.

Brief Summary:
This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: FMX-101, 4% minocycline foam Drug: Vehicle Foam Phase 3

Detailed Description:
This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris. The first 12 weeks of the study involves randomized, double-blind treatment with active FMX-101, 4% or matching vehicle. Subjects who successfully complete the 12-week double blind portion of the study will be offered the opportunity to continue in the trial for up to an additional 40 weeks (for a total of 1 year) and receive open-label treatment with FMX-101, 4%.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 495 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study to Compare the Efficacy, Safety and Long-Term Safety of Topical Administration of FMX-101 for 1 Year in the Treatment of Moderate-to-Severe Acne Vulgaris, Study FX2014-05
Actual Study Start Date : May 2016
Actual Primary Completion Date : October 13, 2017
Actual Study Completion Date : October 13, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: FMX-101, 4% minocycline foam
FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
Drug: FMX-101, 4% minocycline foam
FMX-101, 4% minocycline foam applied topically once daily for 12 weeks

Placebo Comparator: Vehicle Foam
Vehicle foam applied topically once daily for 12 weeks
Drug: Vehicle Foam
Vehicle foam applied topically once daily for 12 weeks




Primary Outcome Measures :
  1. Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12 [ Time Frame: Baseline and Week 12 ]
    To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.

  2. Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12 [ Time Frame: Baseline and Week 12 ]
    The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline.


Secondary Outcome Measures :
  1. Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12 [ Time Frame: Baseline and Week 12 ]
    To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Percent change from baseline is calculated as the baseline value minus the post-baseline value divided by the baseline value, expressed as a percentage. Non-inflammatory lesions included: open comedones (blackhead) and closed comedones (whitehead).

  2. Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9 [ Time Frame: Baseline, Week 6 and Week 9 ]
    To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.

  3. Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9 [ Time Frame: Baseline, Week 6 and Week 9 ]
    The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline.

  4. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [ Time Frame: Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52 ]
    To evaluate the safety compared to vehicle of topical FMX101 4% administered daily for 12 weeks and to evaluate the long-term safety of topical FMX101 4% administered daily for up to an additional 40 weeks. TEAEs of the double-blind phase were defined as AEs starting on or after date of first application of investigational product (IP), but before the date of the first application of the open-label phase, and AEs starting on or after the first application of the open-label phase are considered as TEAEs of the open-label phase.



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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has facial acne vulgaris with:

    • 20 to 50 inflammatory lesions (papules, pustules, and nodules)
    • 25 to 100 noninflammatory lesions (open and closed comedones)
    • No more than 2 nodules on the face
    • IGA score of moderate (3) to severe (4)
  • 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:

  • 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
  • Sunburn on the face

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): NCT02815280


Locations
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United States, Arizona
Glendale, Arizona, United States, 85308
United States, Arkansas
Rogers, Arkansas, United States, 72758
United States, California
Oceanside, California, United States, 92049
United States, Colorado
Denver, Colorado, United States, 80220
United States, Florida
Hialeah, Florida, United States, 33016
Miami, Florida, United States, 33126
Miami, Florida, United States, 33175
Sweetwater, Florida, United States, 33172
United States, Georgia
Marietta, Georgia, United States, 30060
Snellville, Georgia, United States, 30078
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Indiana
Carmel, Indiana, United States, 46032
Indianapolis, Indiana, United States, 46256
United States, Kansas
Overland Park, Kansas, United States, 66215
United States, Kentucky
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Crowley, Louisiana, United States, 70526
United States, Michigan
Clarkston, Michigan, United States, 48346
Detroit, Michigan, United States, 48202
United States, New Jersey
Montclair, New Jersey, United States, 07042
Verona, New Jersey, United States, 07044
United States, New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
Bronx, New York, United States, 10458
New York, New York, United States, 10022
United States, North Carolina
Raleigh, North Carolina, United States, 27612
United States, Ohio
Cleveland, Ohio, United States, 44121
United States, Pennsylvania
Hazleton, Pennsylvania, United States, 18201
United States, Tennessee
Chattanooga, Tennessee, United States, 37421
Goodlettsville, Tennessee, United States, 37072
United States, Texas
Austin, Texas, United States, 78746
New Braunfels, Texas, United States, 78130
Port Arthur, Texas, United States, 77640
San Antonio, Texas, United States, 78229
Sugar Land, Texas, United States, 77479
United States, Utah
Salt Lake City, Utah, United States, 84117
United States, Washington
Seattle, Washington, United States, 98104
Dominican Republic
Santo Domingo, Dominican Republic
Sponsors and Collaborators
Vyne Therapeutics Inc.
  Study Documents (Full-Text)

Documents provided by Vyne Therapeutics Inc.:
Study Protocol  [PDF] October 14, 2016
Statistical Analysis Plan  [PDF] December 7, 2017

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Responsible Party: Vyne Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02815280    
Other Study ID Numbers: FX2014-05
First Posted: June 28, 2016    Key Record Dates
Results First Posted: November 24, 2020
Last Update Posted: January 18, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Vyne Therapeutics Inc.:
acne
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents