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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: NCT02815267
Recruitment Status : Completed
First Posted : June 28, 2016
Results First Posted : September 22, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Foamix Ltd.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 466 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 FX2014-04
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
Subjects will apply the assigned FMX-101, 4% minocycline foam topically once daily for 12 weeks as directed
Drug: FMX-101, 4% minocycline foam
FMX-101, 4% minocycline foam applied topically once daily for 12 weeks

Placebo Comparator: Vehicle foam
Subjects will apply the assigned vehicle foam topically once daily for 12 weeks as directed
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, at Week 6 and at 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, at Week 6 and at 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 and Treatment-emergent Serious Adverse Events (TESAEs) [ Time Frame: Double blind: Screening Day 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; and
    • 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
  • Severe systemic disease, which might interfere with the conduct of the study or the interpretation of the results.
  • Abnormal baseline laboratory values that are considered clinically significant
  • Allergy to tetracycline-class antibiotics or to any ingredient in the study drug
  • Pseudomembranous colitis or antibiotic-associated colitis

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): NCT02815267


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35205
United States, California
Fremont, California, United States, 94538
Fullerton, California, United States, 92835
United States, Connecticut
Shelton, Connecticut, United States, 06484
United States, District of Columbia
Washington, District of Columbia, United States, 20037
United States, Florida
Boynton Beach, Florida, United States, 33437
Miami, Florida, United States, 33015
Miami, Florida, United States, 33174
Miramar, Florida, United States, 33027
Sanford, Florida, United States, 32771
United States, Georgia
Savannah, Georgia, United States, 31406
United States, Illinois
Oakbrook Terrace, Illinois, United States, 60181
United States, Indiana
Evansville, Indiana, United States, 47713
United States, Louisiana
Metairie, Louisiana, United States, 70006
United States, Maryland
Rockville, Maryland, United States, 20850
United States, Michigan
Bay City, Michigan, United States, 48706
United States, Nebraska
Omaha, Nebraska, United States, 68114
United States, Nevada
Las Vegas, Nevada, United States, 89117
United States, New York
New York, New York, United States, 10012
New York, New York, United States, 10075
United States, North Carolina
High Point, North Carolina, United States, 27262
United States, Ohio
Columbus, Ohio, United States, 43213
United States, Oregon
Gresham, Oregon, United States, 97030
United States, Rhode Island
Johnston, Rhode Island, United States, 02919
United States, Tennessee
Murfreesboro, Tennessee, United States, 37130
United States, Texas
Dallas, Texas, United States, 75234
Plano, Texas, United States, 75024
San Antonio, Texas, United States, 78229
United States, Utah
West Jordan, Utah, United States, 84088
United States, West Virginia
Bridgeport, West Virginia, United States, 26330
Dominican Republic
San Cristobal, Dominican Republic
Sponsors and Collaborators
Foamix Ltd.
  Study Documents (Full-Text)

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

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Responsible Party: Foamix Ltd.
ClinicalTrials.gov Identifier: NCT02815267    
Other Study ID Numbers: FX2014-04
First Posted: June 28, 2016    Key Record Dates
Results First Posted: September 22, 2020
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Foamix Ltd.:
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