Clinical trial NCT02815280: 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 FX2014-05
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: 495
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.

Detailed description: 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. The first 12 weeks of the study involves randomized, double-blind treatment with active FMX-101, 4% or matching vehicle. Subjects who successfully complete the 12-week double blind portion of the study will be offered the opportunity to continue in the trial for up to an additional 40 weeks (for a total of 1 year) and receive open-label treatment with FMX-101, 4%.

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
  * 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

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, Week 6 and Week 9
measure: Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9
timeFrame: Baseline, Week 6 and Week 9
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: Double blind: From Baseline until Week 12; Open-label: Week 16 until Week 52
Other outcomes:
Locations:
city: Glendale
country: United States
state: Arizona
city: Rogers
country: United States
state: Arkansas
city: Oceanside
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Hialeah
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Sweetwater
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Snellville
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Carmel
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: Owensboro
country: United States
state: Kentucky
city: Crowley
country: United States
state: Louisiana
city: Clarkston
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Montclair
country: United States
state: New Jersey
city: Verona
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Hazleton
country: United States
state: Pennsylvania
city: Chattanooga
country: United States
state: Tennessee
city: Goodlettsville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: New Braunfels
country: United States
state: Texas
city: Port Arthur
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Seattle
country: United States
state: Washington
city: Santo Domingo
country: Dominican Republic
Study officials:
References: