A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne
NCT ID: NCT02815280
Last Updated: 2022-01-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
495 participants
INTERVENTIONAL
2016-05-31
2017-10-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne
NCT02815267
A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris
NCT03271021
To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris
NCT04960930
A Study to Compare FCD105 Foam to Minocycline 3% Foam, Adapalene 0.3% Foam and Vehicle Foam.
NCT04104685
Clinical Study to Evaluate Tolerability and Safety of FXFM244 and to Monitor Clinical Effect in Acne Vulgaris Patients
NCT01362010
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FMX-101, 4% minocycline foam
FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
FMX-101, 4% minocycline foam
FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
Vehicle Foam
Vehicle foam applied topically once daily for 12 weeks
Vehicle Foam
Vehicle foam applied topically once daily for 12 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FMX-101, 4% minocycline foam
FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
Vehicle Foam
Vehicle foam applied topically once daily for 12 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Sunburn on the face
9 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vyne Therapeutics Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Glendale, Arizona, United States
Rogers, Arkansas, United States
Oceanside, California, United States
Denver, Colorado, United States
Hialeah, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Sweetwater, Florida, United States
Marietta, Georgia, United States
Snellville, Georgia, United States
Chicago, Illinois, United States
Carmel, Indiana, United States
Indianapolis, Indiana, United States
Overland Park, Kansas, United States
Owensboro, Kentucky, United States
Crowley, Louisiana, United States
Clarkston, Michigan, United States
Detroit, Michigan, United States
Montclair, New Jersey, United States
Verona, New Jersey, United States
Albuquerque, New Mexico, United States
New York, New York, United States
The Bronx, New York, United States
Raleigh, North Carolina, United States
Cleveland, Ohio, United States
Hazleton, Pennsylvania, United States
Chattanooga, Tennessee, United States
Goodlettsville, Tennessee, United States
Austin, Texas, United States
New Braunfels, Texas, United States
Port Arthur, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Santo Domingo, , Dominican Republic
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FX2014-05
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.