Clinical trial NCT02815267: A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: acne
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-28
Enrollment: 466
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12
timeFrame: Baseline and Week 12
measure: Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9
timeFrame: Baseline, at Week 6 and at Week 9
measure: Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9
timeFrame: Baseline, at Week 6 and at Week 9
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and and Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: Double blind: Screening Day until Week 12; Open-label: Week 16 until Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Fremont
country: United States
state: California
city: Fullerton
country: United States
state: California
city: Shelton
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Boynton Beach
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miramar
country: United States
state: Florida
city: Sanford
country: United States
state: Florida
city: Savannah
country: United States
state: Georgia
city: Oakbrook Terrace
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Metairie
country: United States
state: Louisiana
city: Rockville
country: United States
state: Maryland
city: Bay City
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: High Point
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Gresham
country: United States
state: Oregon
city: Johnston
country: United States
state: Rhode Island
city: Murfreesboro
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: West Jordan
country: United States
state: Utah
city: Bridgeport
country: United States
state: West Virginia
city: San Cristobal
country: Dominican Republic
Study officials:
References: