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

Acne Vulgaris Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04104685
• Other study ID #: FX2016-40
• Status: Completed
• Phase: Phase 2
• Start date: September 18, 2019
• Est. completion date: March 3, 2020

Study information

• Verified date: February 2021
• Source: Foamix Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 446
• Est. completion date: March 3, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Combination Product:
• FCD105
Experimental combination

Drug:
• 3% Minocycline Foam
Active Comparator
• 0.3% Adapalene Foam
Active Comparator

Other:
• Vehicle Foam
Placebo

Locations

Country	Name	City	State
United States	Foamix Institution #110	Arlington	Texas
United States	Foamix Institution #126	Baton Rouge	Louisiana
United States	Foamix Institution #134	Bryant	Arkansas
United States	Foamix Institution #114	Clinton Township	Michigan
United States	Foamix Institution #117	College Station	Texas
United States	Foamix Institution #106	Encino	California
United States	Foamix Institution #103	Fremont	California
United States	Foamix Institution #111	Fridley	Minnesota
United States	Foamix Institution #133	Gresham	Oregon
United States	Foamix Institution #107	Hialeah	Florida
United States	Foamix Institution #104	High Point	North Carolina
United States	Foamix Institution #122	Huntington Beach	California
United States	Foamix Institution #125	Johnston	Rhode Island
United States	Foamix Institution #127	Lake City	Florida
United States	Foamix Institution #102	Las Vegas	Nevada
United States	Foamix Institution #131	Layton	Utah
United States	Foamix Institution #123	Louisville	Kentucky
United States	Foamix Institution #109	Manhattan Beach	California
United States	Foamix Institution #101	Miami	Florida
United States	Foamix Institution #135	Miami Beach	Florida
United States	Foamix Institution #119	Mount Pleasant	South Carolina
United States	Foamix Institution #130	New Albany	Indiana
United States	Foamix Institution #124	New Orleans	Louisiana
United States	Foamix Institution #115	New York	New York
United States	Foamix Institution #112	Pflugerville	Texas
United States	Foamix Institution #116	Plainfield	Indiana
United States	Foamix Institution #121	Rogers	Arkansas
United States	Foamix Institution #105	San Antonio	Texas
United States	Foamix Institution #132	San Diego	California
United States	Foamix Institution #118	Sanford	Florida
United States	Foamix Institution #113	Spokane	Washington
United States	Foamix Institution #108	Stony Brook	New York
United States	Foamix Institution #120	Sunrise	Florida
United States	Foamix Institution #128	Tampa	Florida
United States	Foamix Institution #136	Watertown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Foamix Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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