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

NCT04104685 | Completed Phase 2 FDA Drug

• 1 other identifier: FX2016-40
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 35

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

FCD105 Foam

EXPERIMENTAL

FCD105 Foam

Combination Product: FCD105

3% Minocycline Foam

ACTIVE COMPARATOR

3% Minocycline Foam

Drug: 3% Minocycline Foam

0.3% Adapalene Foam

ACTIVE COMPARATOR

0.3% Adapalene Foam

Drug: 0.3% Adapalene Foam

Vehicle Foam

PLACEBO COMPARATOR

Vehicle Foam

Other: Vehicle Foam

Interventions

FCD105 COMBINATION_PRODUCT

Experimental combination

FCD105 Foam

3% Minocycline Foam DRUG

Active Comparator

3% Minocycline Foam

0.3% Adapalene Foam DRUG

Active Comparator

0.3% Adapalene Foam

Vehicle Foam OTHER

Placebo

Vehicle Foam

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Has facial acne vulgaris with all of the following:
• to 50 inflammatory lesions (papules and/or pustules) on the face.
• to 100 non-inflammatory lesions (open and closed comedones) on the face.
• IGA score of moderate (3) to severe (4).
• No more than two active nodules on the face.
• 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

You may not qualify if:

• Female who is pregnant or lactating, or is planning a pregnancy during the study.
• Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face that could interfere with the clinical evaluations.
• Facial hair (eg, beard, mustache, etc.) that could interfere with the clinical evaluations.
• Sunburn on the face.
• Severe systemic disease as assessed by the Investigator that might interfere with the conduct of the study or the interpretation of the results.
• Subjects who have a documented history of any of the following:
• Allergy to tetracycline-class antibiotics or to any ingredient in the study drug.
• Pseudomembranous colitis or antibiotic-associated colitis.
• Hepatitis or clinically significant liver damage or clinically significant renal impairment.
• Known or suspected premalignant or malignant disease (excluding successfully treated skin cancers).
• 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:

Sponsors & Collaborators

• Vyne Therapeutics Inc.: lead

Study Sites (35)

Foamix Institution #134

Bryant, Arkansas, 72022, United States

Location

Foamix Institution #121

Rogers, Arkansas, 72758, United States

Location

Foamix Institution #106

Encino, California, 91436, United States

Location

Foamix Institution #103

Fremont, California, 94538, United States

Location

Foamix Institution #122

Huntington Beach, California, 92647, United States

Location

Foamix Institution #109

Manhattan Beach, California, 90266, United States

Location

Foamix Institution #132

San Diego, California, 92123, United States

Location

Foamix Institution #107

Hialeah, Florida, 33016, United States

Location

Foamix Institution #127

Lake City, Florida, 32055, United States

Location

Foamix Institution #101

Miami, Florida, 33126, United States

Location

Foamix Institution #135

Miami Beach, Florida, 33162, United States

Location

Foamix Institution #118

Sanford, Florida, 32771, United States

Location

Foamix Institution #120

Sunrise, Florida, 33351, United States

Location

Foamix Institution #128

Tampa, Florida, 33607, United States

Location

Foamix Institution #130

New Albany, Indiana, 47150, United States

Location

Foamix Institution #116

Plainfield, Indiana, 46168, United States

Location

Foamix Institution #123

Louisville, Kentucky, 40241, United States

Location

Foamix Institution #126

Baton Rouge, Louisiana, 70809, United States

Location

Foamix Institution #124

New Orleans, Louisiana, 70115, United States

Location

Foamix Institution #136

Watertown, Massachusetts, 02472, United States

Location

Foamix Institution #114

Clinton Township, Michigan, 48038, United States

Location

Foamix Institution #111

Fridley, Minnesota, 55432, United States

Location

Foamix Institution #102

Las Vegas, Nevada, 89148, United States

Location

Foamix Institution #115

New York, New York, 10022, United States

Location

Foamix Institution #108

Stony Brook, New York, 11790, United States

Location

Foamix Institution #104

High Point, North Carolina, 27262, United States

Location

Foamix Institution #133

Gresham, Oregon, 97030, United States

Location

Foamix Institution #125

Johnston, Rhode Island, 02919, United States

Location

Foamix Institution #119

Mt. Pleasant, South Carolina, 29464, United States

Location

Foamix Institution #110

Arlington, Texas, 76011, United States

Location

Foamix Institution #117

College Station, Texas, 77845, United States

Location

Foamix Institution #112

Pflugerville, Texas, 78660, United States

Location

Foamix Institution #105

San Antonio, Texas, 78213, United States

Location

Foamix Institution #131

Layton, Utah, 84041, United States

Location

Foamix Institution #113

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: September 18, 2019
• Primary Completion: February 28, 2020
• Study Completion: March 3, 2020
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (35)