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 FX2014-05
1 other identifier
interventional
495
2 countries
36
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
36 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
November 24, 2020
CompletedJanuary 18, 2022
January 1, 2022
1.5 years
May 24, 2016
October 21, 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, Week 6 and Week 9
Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9
Baseline, Week 6 and Week 9
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52
Study Arms (2)
FMX-101, 4% minocycline foam
EXPERIMENTALFMX-101, 4% minocycline foam applied topically once daily for 12 weeks
Vehicle Foam
PLACEBO COMPARATORVehicle foam applied topically once daily for 12 weeks
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Unknown Facility
Glendale, Arizona, 85308, United States
Unknown Facility
Rogers, Arkansas, 72758, United States
Unknown Facility
Oceanside, California, 92049, United States
Unknown Facility
Denver, Colorado, 80220, United States
Unknown Facility
Hialeah, Florida, 33016, United States
Unknown Facility
Miami, Florida, 33126, United States
Unknown Facility
Miami, Florida, 33175, United States
Unknown Facility
Sweetwater, Florida, 33172, United States
Unknown Facility
Marietta, Georgia, 30060, United States
Unknown Facility
Snellville, Georgia, 30078, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Carmel, Indiana, 46032, United States
Unknown Facility
Indianapolis, Indiana, 46256, United States
Unknown Facility
Overland Park, Kansas, 66215, United States
Unknown Facility
Owensboro, Kentucky, 42303, United States
Unknown Facility
Crowley, Louisiana, 70526, United States
Unknown Facility
Clarkston, Michigan, 48346, United States
Unknown Facility
Detroit, Michigan, 48202, United States
Unknown Facility
Montclair, New Jersey, 07042, United States
Unknown Facility
Verona, New Jersey, 07044, United States
Unknown Facility
Albuquerque, New Mexico, 87106, United States
Unknown Facility
New York, New York, 10022, United States
Unknown Facility
The Bronx, New York, 10458, United States
Unknown Facility
Raleigh, North Carolina, 27612, United States
Unknown Facility
Cleveland, Ohio, 44121, United States
Unknown Facility
Hazleton, Pennsylvania, 18201, United States
Unknown Facility
Chattanooga, Tennessee, 37421, United States
Unknown Facility
Goodlettsville, Tennessee, 37072, United States
Unknown Facility
Austin, Texas, 78746, United States
Unknown Facility
New Braunfels, Texas, 78130, United States
Unknown Facility
Port Arthur, Texas, 77640, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Sugar Land, Texas, 77479, United States
Unknown Facility
Salt Lake City, Utah, 84117, United States
Unknown Facility
Seattle, Washington, 98104, United States
Unknown Facility
Santo Domingo, 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
- LTE60
- 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
November 24, 2020
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share