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

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: FMX-101, 4% minocycline foam; Drug: Vehicle Foam

• Study Type: Interventional
• Enrollment (Actual): 466
• Phase: Phase 3

Contacts and Locations

Study Locations

• Dominican Republic
  • San Cristobal, Dominican Republic
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
  • California
    • Fremont, California, United States, 94538
    • Fullerton, California, United States, 92835
  • Connecticut
    • Shelton, Connecticut, United States, 06484
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
  • 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
  • Georgia
    • Savannah, Georgia, United States, 31406
  • Illinois
    • Oakbrook Terrace, Illinois, United States, 60181
  • Indiana
    • Evansville, Indiana, United States, 47713
  • Louisiana
    • Metairie, Louisiana, United States, 70006
  • Maryland
    • Rockville, Maryland, United States, 20850
  • Michigan
    • Bay City, Michigan, United States, 48706
  • Nebraska
    • Omaha, Nebraska, United States, 68114
  • Nevada
    • Las Vegas, Nevada, United States, 89117
  • New York
    • New York, New York, United States, 10075
    • New York, New York, United States, 10012
  • North Carolina
    • High Point, North Carolina, United States, 27262
  • Ohio
    • Columbus, Ohio, United States, 43213
  • Oregon
    • Gresham, Oregon, United States, 97030
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
  • Texas
    • Dallas, Texas, United States, 75234
    • Plano, Texas, United States, 75024
    • San Antonio, Texas, United States, 78229
  • Utah
    • West Jordan, Utah, United States, 84088
  • West Virginia
    • Bridgeport, West Virginia, United States, 26330

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change From Baseline in the Inflammatory Lesion Count at 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.	Baseline and Week 12
Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at 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.	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in the Non-inflammatory Lesion Count at 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).	Baseline and Week 12
Absolute Change From Baseline in the Inflammatory Lesion Count at 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.	Baseline, at Week 6 and at Week 9
Percentage of Participants Achieving IGA Treatment Success at 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.	Baseline, at Week 6 and at Week 9
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and and Treatment-emergent Serious Adverse Events (TESAEs)	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.	Double blind: Screening Day until Week 12; Open-label: Week 16 until Week 52

Collaborators and Investigators

• Sponsor: Vyne Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): October 13, 2017
• Study Completion (Actual): October 13, 2017

Study Registration Dates

• First Submitted: May 24, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: acne
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: FX2014-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No