A Study to Compare FCD105 Foam to Minocycline 3% Foam, Adapalene 0.3% Foam and Vehicle Foam.

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)

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Combination product: FCD105; Drug: 3% Minocycline Foam; Drug: 0.3% Adapalene Foam; Other: Vehicle Foam

• Study Type: Interventional
• Enrollment (Actual): 446
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Foamix Institution #134
    • Rogers, Arkansas, United States, 72758
      • Foamix Institution #121
  • California
    • Encino, California, United States, 91436
      • Foamix Institution #106
    • Fremont, California, United States, 94538
      • Foamix Institution #103
    • Huntington Beach, California, United States, 92647
      • Foamix Institution #122
    • Manhattan Beach, California, United States, 90266
      • Foamix Institution #109
    • San Diego, California, United States, 92123
      • Foamix Institution #132
  • Florida
    • Hialeah, Florida, United States, 33016
      • Foamix Institution #107
    • Lake City, Florida, United States, 32055
      • Foamix Institution #127
    • Miami, Florida, United States, 33126
      • Foamix Institution #101
    • Miami Beach, Florida, United States, 33162
      • Foamix Institution #135
    • Sanford, Florida, United States, 32771
      • Foamix Institution #118
    • Sunrise, Florida, United States, 33351
      • Foamix Institution #120
    • Tampa, Florida, United States, 33607
      • Foamix Institution #128
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Foamix Institution #130
    • Plainfield, Indiana, United States, 46168
      • Foamix Institution #116
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Foamix Institution #123
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Foamix Institution #126
    • New Orleans, Louisiana, United States, 70115
      • Foamix Institution #124
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
      • Foamix Institution #136
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Foamix Institution #114
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Foamix Institution #111
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Foamix Institution #102
  • New York
    • New York, New York, United States, 10022
      • Foamix Institution #115
    • Stony Brook, New York, United States, 11790
      • Foamix Institution #108
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Foamix Institution #104
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Foamix Institution #133
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Foamix Institution #125
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Foamix Institution #119
  • Texas
    • Arlington, Texas, United States, 76011
      • Foamix Institution #110
    • College Station, Texas, United States, 77845
      • Foamix Institution #117
    • Pflugerville, Texas, United States, 78660
      • Foamix Institution #112
    • San Antonio, Texas, United States, 78213
      • Foamix Institution #105
  • Utah
    • Layton, Utah, United States, 84041
      • Foamix Institution #131
  • Washington
    • Spokane, Washington, United States, 99202
      • Foamix Institution #113

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: FCD105 Foam	Combination product: FCD105; Experimental combination
ACTIVE_COMPARATOR: 3% Minocycline Foam	Drug: 3% Minocycline Foam; Active Comparator
ACTIVE_COMPARATOR: 0.3% Adapalene Foam	Drug: 0.3% Adapalene Foam; Active Comparator
PLACEBO_COMPARATOR: Vehicle Foam	Other: Vehicle Foam; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change from Baseline in inflammatory lesion counts at week 12	Statistical superiority of FCD105 vs. vehicle in the absolute change from Baseline in inflammatory lesion counts at Visit 4 (Week12/End of Treatment)	12 weeks
Absolute change from Baseline in non-inflammatory lesion counts at week 12	Statistical superiority of FCD105 vs. vehicle in the absolute change from Baseline in non-inflammatory lesion counts at Visit 4 (Week12/End of Treatment)	12 weeks
Investigator's Global Assessment (IGA) Treatment Success at Week 12	Statistical superiority of FCD105 vs. vehicle in in IGA Treatment Success at Visit 4 (Week 12/End of Treatment), where success is defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from Baseline.	12 weeks

Collaborators and Investigators

• Sponsor: Vyne Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 18, 2019
• Primary Completion (ACTUAL): February 28, 2020
• Study Completion (ACTUAL): March 3, 2020

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (ACTUAL): September 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Anti-Bacterial Agents; Minocycline; Adapalene
• Other Study ID Numbers: FX2016-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No