Clinical trial NCT04104685: A Study to Compare FCD105 Foam to Minocycline 3% Foam, Adapalene 0.3% Foam and Vehicle Foam.
Official title: A Prospective, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of a Combination of 3% Minocycline and 0.3% Adapalene Topical Foam Formulation for the Treatment of Moderate-to-Severe Acne (Study FX2016 40)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-26
Enrollment: 446
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study comparing FCD105 to 3% minocycline foam, 0.3% adapalene foam and vehicle foam in patients ≥ 12 years old for the treatment of moderate-to-severe acne.


Eligibility criteria: Inclusion Criteria:

1. Has facial acne vulgaris with all of the following:

   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:

1. Female who is pregnant or lactating, or is planning a pregnancy during the study.
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

Primary outcomes:
measure: Absolute change from Baseline in inflammatory lesion counts at week 12
timeFrame: 12 weeks
measure: Absolute change from Baseline in non-inflammatory lesion counts at week 12
timeFrame: 12 weeks
measure: Investigator's Global Assessment (IGA) Treatment Success at Week 12
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bryant
country: United States
facility: Foamix Institution #134
state: Arkansas
city: Rogers
country: United States
facility: Foamix Institution #121
state: Arkansas
city: Encino
country: United States
facility: Foamix Institution #106
state: California
city: Fremont
country: United States
facility: Foamix Institution #103
state: California
city: Huntington Beach
country: United States
facility: Foamix Institution #122
state: California
city: Manhattan Beach
country: United States
facility: Foamix Institution #109
state: California
city: San Diego
country: United States
facility: Foamix Institution #132
state: California
city: Hialeah
country: United States
facility: Foamix Institution #107
state: Florida
city: Lake City
country: United States
facility: Foamix Institution #127
state: Florida
city: Miami Beach
country: United States
facility: Foamix Institution #135
state: Florida
city: Miami
country: United States
facility: Foamix Institution #101
state: Florida
city: Sanford
country: United States
facility: Foamix Institution #118
state: Florida
city: Sunrise
country: United States
facility: Foamix Institution #120
state: Florida
city: Tampa
country: United States
facility: Foamix Institution #128
state: Florida
city: New Albany
country: United States
facility: Foamix Institution #130
state: Indiana
city: Plainfield
country: United States
facility: Foamix Institution #116
state: Indiana
city: Louisville
country: United States
facility: Foamix Institution #123
state: Kentucky
city: Baton Rouge
country: United States
facility: Foamix Institution #126
state: Louisiana
city: New Orleans
country: United States
facility: Foamix Institution #124
state: Louisiana
city: Watertown
country: United States
facility: Foamix Institution #136
state: Massachusetts
city: Clinton Township
country: United States
facility: Foamix Institution #114
state: Michigan
city: Fridley
country: United States
facility: Foamix Institution #111
state: Minnesota
city: Las Vegas
country: United States
facility: Foamix Institution #102
state: Nevada
city: New York
country: United States
facility: Foamix Institution #115
state: New York
city: Stony Brook
country: United States
facility: Foamix Institution #108
state: New York
city: High Point
country: United States
facility: Foamix Institution #104
state: North Carolina
city: Gresham
country: United States
facility: Foamix Institution #133
state: Oregon
city: Johnston
country: United States
facility: Foamix Institution #125
state: Rhode Island
city: Mount Pleasant
country: United States
facility: Foamix Institution #119
state: South Carolina
city: Arlington
country: United States
facility: Foamix Institution #110
state: Texas
city: College Station
country: United States
facility: Foamix Institution #117
state: Texas
city: Pflugerville
country: United States
facility: Foamix Institution #112
state: Texas
city: San Antonio
country: United States
facility: Foamix Institution #105
state: Texas
city: Layton
country: United States
facility: Foamix Institution #131
state: Utah
city: Spokane
country: United States
facility: Foamix Institution #113
state: Washington
Study officials:
References: