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

• Sponsor: Vyne Therapeutics Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04104685
• Collaborator: (none)
• Enrollment: 446
• Locations: 35
• Arms: 4
• Actual Duration (Months): 5.5
• Patients Per Site: 12.7
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Combination Product: FCD105; Drug: 3% Minocycline Foam; Drug: 0.3% Adapalene Foam; Other: Vehicle Foam	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 446 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Sep 18, 2019
• Actual Primary Completion Date: Feb 28, 2020
• Actual Study Completion Date: Mar 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FCD105 Foam FCD105 Foam	Combination Product: FCD105; Experimental combination
Active Comparator: 3% Minocycline Foam 3% Minocycline Foam	Drug: 3% Minocycline Foam; Active Comparator
Active Comparator: 0.3% Adapalene Foam 0.3% Adapalene Foam	Drug: 0.3% Adapalene Foam; Active Comparator
Placebo Comparator: Vehicle Foam Vehicle Foam	Other: Vehicle Foam; Placebo

Outcome Measures

Primary Outcome Measures

1. Absolute change from Baseline in inflammatory lesion counts at week 12 [12 weeks]

   Statistical superiority of FCD105 vs. vehicle in the absolute change from Baseline in inflammatory lesion counts at Visit 4 (Week12/End of Treatment)

2. Absolute change from Baseline in non-inflammatory lesion counts at week 12 [12 weeks]

   Statistical superiority of FCD105 vs. vehicle in the absolute change from Baseline in non-inflammatory lesion counts at Visit 4 (Week12/End of Treatment)

3. Investigator's Global Assessment (IGA) Treatment Success at Week 12 [12 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

2. 20 to 50 inflammatory lesions (papules and/or pustules) on the face.

3. 25 to 100 non-inflammatory lesions (open and closed comedones) on the face.

4. IGA score of moderate (3) to severe (4).

5. No more than two active nodules on the face.

6. 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:

7. Allergy to tetracycline-class antibiotics or to any ingredient in the study drug.

8. Pseudomembranous colitis or antibiotic-associated colitis.

9. Hepatitis or clinically significant liver damage or clinically significant renal impairment.

10. Known or suspected premalignant or malignant disease (excluding successfully treated skin cancers).

11. 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).

1. Use of sauna during the 2 weeks prior to randomization.

2. Epilation of the face within 2 weeks prior to randomization.

3. Folliculitis on the face.

4. Documented history of depression that is not, in the opinion of the Investigator, currently adequately controlled with medication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Foamix Institution #134	Bryant	Arkansas	United States	72022
2	Foamix Institution #121	Rogers	Arkansas	United States	72758
3	Foamix Institution #106	Encino	California	United States	91436
4	Foamix Institution #103	Fremont	California	United States	94538
5	Foamix Institution #122	Huntington Beach	California	United States	92647
6	Foamix Institution #109	Manhattan Beach	California	United States	90266
7	Foamix Institution #132	San Diego	California	United States	92123
8	Foamix Institution #107	Hialeah	Florida	United States	33016
9	Foamix Institution #127	Lake City	Florida	United States	32055
10	Foamix Institution #135	Miami Beach	Florida	United States	33162
11	Foamix Institution #101	Miami	Florida	United States	33126
12	Foamix Institution #118	Sanford	Florida	United States	32771
13	Foamix Institution #120	Sunrise	Florida	United States	33351
14	Foamix Institution #128	Tampa	Florida	United States	33607
15	Foamix Institution #130	New Albany	Indiana	United States	47150
16	Foamix Institution #116	Plainfield	Indiana	United States	46168
17	Foamix Institution #123	Louisville	Kentucky	United States	40241
18	Foamix Institution #126	Baton Rouge	Louisiana	United States	70809
19	Foamix Institution #124	New Orleans	Louisiana	United States	70115
20	Foamix Institution #136	Watertown	Massachusetts	United States	02472
21	Foamix Institution #114	Clinton Township	Michigan	United States	48038
22	Foamix Institution #111	Fridley	Minnesota	United States	55432
23	Foamix Institution #102	Las Vegas	Nevada	United States	89148
24	Foamix Institution #115	New York	New York	United States	10022
25	Foamix Institution #108	Stony Brook	New York	United States	11790
26	Foamix Institution #104	High Point	North Carolina	United States	27262
27	Foamix Institution #133	Gresham	Oregon	United States	97030
28	Foamix Institution #125	Johnston	Rhode Island	United States	02919
29	Foamix Institution #119	Mount Pleasant	South Carolina	United States	29464
30	Foamix Institution #110	Arlington	Texas	United States	76011
31	Foamix Institution #117	College Station	Texas	United States	77845
32	Foamix Institution #112	Pflugerville	Texas	United States	78660
33	Foamix Institution #105	San Antonio	Texas	United States	78213
34	Foamix Institution #131	Layton	Utah	United States	84041
35	Foamix Institution #113	Spokane	Washington	United States	99202

Sponsors and Collaborators

• Vyne Therapeutics Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vyne Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT04104685
• Other Study ID Numbers: FX2016-40
• First Posted: Sep 26, 2019
• Last Update Posted: Feb 5, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acne Vulgaris; Minocycline; Adapalene

Study Results

No Results Posted as of Feb 5, 2021