A Study to Compare FCD105 Foam to Minocycline 3% Foam, Adapalene 0.3% Foam and Vehicle Foam.
NCT ID: NCT04104685
Last Updated: 2021-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
446 participants
INTERVENTIONAL
2019-09-18
2020-03-03
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
NCT02815280
A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne
NCT02815267
To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris
NCT04960930
A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris
NCT03271021
A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris
NCT04940767
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.
FCD105 Foam
FCD105 Foam
FCD105
Experimental combination
3% Minocycline Foam
3% Minocycline Foam
3% Minocycline Foam
Active Comparator
0.3% Adapalene Foam
0.3% Adapalene Foam
0.3% Adapalene Foam
Active Comparator
Vehicle Foam
Vehicle Foam
Vehicle Foam
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FCD105
Experimental combination
3% Minocycline Foam
Active Comparator
0.3% Adapalene Foam
Active Comparator
Vehicle Foam
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. 20 to 50 inflammatory lesions (papules and/or pustules) on the face.
2. 25 to 100 non-inflammatory lesions (open and closed comedones) on the face.
3. IGA score of moderate (3) to severe (4).
2. No more than two active nodules on the face.
3. Willing to use only the supplied non-medicated 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
2. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face that could interfere with the clinical evaluations.
3. Facial hair (eg, beard, mustache, etc.) that could interfere with the clinical evaluations.
4. Sunburn on the face.
5. Severe systemic disease as assessed by the Investigator that might interfere with the conduct of the study or the interpretation of the results.
6. Subjects who have a documented history of any of the following:
1. Allergy to tetracycline-class antibiotics or to any ingredient in the study drug.
2. Pseudomembranous colitis or antibiotic-associated colitis.
3. Hepatitis or clinically significant liver damage or clinically significant renal impairment.
4. Known or suspected premalignant or malignant disease (excluding successfully treated skin cancers).
7. Subjects who have used the following medications:
Within 1 week prior to randomization:
* Medicated facial cleansers on the face.
* Topical acne treatments on the face (other than those listed below).
Within 4 weeks prior to randomization:
* Topical retinoids on the face.
* Topical anti-inflammatories and/or corticosteroids on the face.
* Topical corticosteroids on body areas other than the face for more than 15 consecutive days and on more than 10% of the body surface area. In body folds, such as axillary and inguinal regions, only mild topical steroids are allowed for short term use (≤15 consecutive days).
* Systemic antibiotics.
* Systemic acne treatments.
Within 12 weeks prior to randomization:
* Systemic retinoids.
* Systemic corticosteroids (Note: Intranasal and inhaled corticosteroids may be used throughout the study if the subject is on a stable dose).
8. Use of sauna during the 2 weeks prior to randomization.
9. Epilation of the face within 2 weeks prior to randomization.
10. Folliculitis on the face.
11. Documented history of depression that is not, in the opinion of the Investigator, currently adequately controlled with medication
12 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.
Foamix Institution #134
Bryant, Arkansas, United States
Foamix Institution #121
Rogers, Arkansas, United States
Foamix Institution #106
Encino, California, United States
Foamix Institution #103
Fremont, California, United States
Foamix Institution #122
Huntington Beach, California, United States
Foamix Institution #109
Manhattan Beach, California, United States
Foamix Institution #132
San Diego, California, United States
Foamix Institution #107
Hialeah, Florida, United States
Foamix Institution #127
Lake City, Florida, United States
Foamix Institution #101
Miami, Florida, United States
Foamix Institution #135
Miami Beach, Florida, United States
Foamix Institution #118
Sanford, Florida, United States
Foamix Institution #120
Sunrise, Florida, United States
Foamix Institution #128
Tampa, Florida, United States
Foamix Institution #130
New Albany, Indiana, United States
Foamix Institution #116
Plainfield, Indiana, United States
Foamix Institution #123
Louisville, Kentucky, United States
Foamix Institution #126
Baton Rouge, Louisiana, United States
Foamix Institution #124
New Orleans, Louisiana, United States
Foamix Institution #136
Watertown, Massachusetts, United States
Foamix Institution #114
Clinton Township, Michigan, United States
Foamix Institution #111
Fridley, Minnesota, United States
Foamix Institution #102
Las Vegas, Nevada, United States
Foamix Institution #115
New York, New York, United States
Foamix Institution #108
Stony Brook, New York, United States
Foamix Institution #104
High Point, North Carolina, United States
Foamix Institution #133
Gresham, Oregon, United States
Foamix Institution #125
Johnston, Rhode Island, United States
Foamix Institution #119
Mt. Pleasant, South Carolina, United States
Foamix Institution #110
Arlington, Texas, United States
Foamix Institution #117
College Station, Texas, United States
Foamix Institution #112
Pflugerville, Texas, United States
Foamix Institution #105
San Antonio, Texas, United States
Foamix Institution #131
Layton, Utah, United States
Foamix Institution #113
Spokane, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FX2016-40
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.