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
1 other identifier
interventional
466
2 countries
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2016
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 24, 2016
CompletedFirst Posted
Study publicly available on registry
June 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2017
CompletedResults Posted
Study results publicly available
September 22, 2020
CompletedJanuary 18, 2022
January 1, 2022
1.5 years
May 24, 2016
September 1, 2020
January 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12
Baseline and Week 12
Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9
Baseline, at Week 6 and at Week 9
Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9
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)
Double blind: Screening Day until Week 12; Open-label: Week 16 until Week 52
Study Arms (2)
FMX-101, 4% minocycline foam
EXPERIMENTALSubjects will apply the assigned FMX-101, 4% minocycline foam topically once daily for 12 weeks as directed
Vehicle foam
PLACEBO COMPARATORSubjects will apply the assigned vehicle foam topically once daily for 12 weeks as directed
Interventions
FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
Eligibility Criteria
You may qualify if:
- Has facial acne vulgaris with:
- to 50 inflammatory lesions (papules, pustules, and nodules);
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Unknown Facility
Birmingham, Alabama, 35205, United States
Unknown Facility
Fremont, California, 94538, United States
Unknown Facility
Fullerton, California, 92835, United States
Unknown Facility
Shelton, Connecticut, 06484, United States
Unknown Facility
Washington D.C., District of Columbia, 20037, United States
Unknown Facility
Boynton Beach, Florida, 33437, United States
Unknown Facility
Miami, Florida, 33015, United States
Unknown Facility
Miami, Florida, 33174, United States
Unknown Facility
Miramar, Florida, 33027, United States
Unknown Facility
Sanford, Florida, 32771, United States
Unknown Facility
Savannah, Georgia, 31406, United States
Unknown Facility
Oakbrook Terrace, Illinois, 60181, United States
Unknown Facility
Evansville, Indiana, 47713, United States
Unknown Facility
Metairie, Louisiana, 70006, United States
Unknown Facility
Rockville, Maryland, 20850, United States
Unknown Facility
Bay City, Michigan, 48706, United States
Unknown Facility
Omaha, Nebraska, 68114, United States
Unknown Facility
Las Vegas, Nevada, 89117, United States
Unknown Facility
New York, New York, 10012, United States
Unknown Facility
New York, New York, 10075, United States
Unknown Facility
High Point, North Carolina, 27262, United States
Unknown Facility
Columbus, Ohio, 43213, United States
Unknown Facility
Gresham, Oregon, 97030, United States
Unknown Facility
Johnston, Rhode Island, 02919, United States
Unknown Facility
Murfreesboro, Tennessee, 37130, United States
Unknown Facility
Dallas, Texas, 75234, United States
Unknown Facility
Plano, Texas, 75024, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
West Jordan, Utah, 84088, United States
Unknown Facility
Bridgeport, West Virginia, 26330, United States
Unknown Facility
San Cristóbal, Dominican Republic
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Iain Stuart, PhD.
- Organization
- Foamix Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2016
First Posted
June 28, 2016
Study Start
May 1, 2016
Primary Completion
October 13, 2017
Study Completion
October 13, 2017
Last Updated
January 18, 2022
Results First Posted
September 22, 2020
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share