Back to resultsA Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
FMX-101, 4% minocycline foam
Vehicle Foam
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring acne
Eligibility Criteria
Inclusion Criteria:
Has facial acne vulgaris with:
- 20 to 50 inflammatory lesions (papules, pustules, and nodules);
- 25 to 100 noninflammatory lesions (open and closed comedones);
- no more than 2 nodules on the face; and
- IGA score of moderate (3) to severe (4)
- Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin 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:
- Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne) or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations
- Sunburn on the face
- Severe systemic disease, which might interfere with the conduct of the study or the interpretation of the results.
- Abnormal baseline laboratory values that are considered clinically significant
- Allergy to tetracycline-class antibiotics or to any ingredient in the study drug
- Pseudomembranous colitis or antibiotic-associated colitis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
FMX-101, 4% minocycline foam
Vehicle foam
Arm Description
Subjects will apply the assigned FMX-101, 4% minocycline foam topically once daily for 12 weeks as directed
Subjects will apply the assigned vehicle foam topically once daily for 12 weeks as directed
Outcomes
Primary Outcome Measures
Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12
To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.
Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12
The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline.
Secondary Outcome Measures
Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12
To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Percent change from Baseline is calculated as the Baseline value minus the post-Baseline value divided by the baseline value, expressed as a percentage. Non-inflammatory lesions included: open comedones (blackhead) and closed comedones (whitehead).
Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9
To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.
Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9
The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and and Treatment-emergent Serious Adverse Events (TESAEs)
To evaluate the safety compared to vehicle of topical FMX101 4% administered daily for 12 weeks and to evaluate the long-term safety of topical FMX101 4% administered daily for up to an additional 40 weeks. TEAEs of the double-blind phase were defined as AEs starting on or after date of first application of investigational product (IP), but before the date of the first application of the open-label phase, and AEs starting on or after the first application of the open-label phase are considered as TEAEs of the open-label phase.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02815267
Brief Title
A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne
Official Title
A Randomized, Double-Blind Study to Compare the Efficacy, Safety and Long-Term Safety of Topical Administration of FMX-101 for 1 Year in the Treatment of Moderate-to-Severe Acne Vulgaris, Study FX2014-04
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
October 13, 2017 (Actual)
Study Completion Date
October 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vyne Therapeutics Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
466 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FMX-101, 4% minocycline foam
Arm Type
Experimental
Arm Description
Subjects will apply the assigned FMX-101, 4% minocycline foam topically once daily for 12 weeks as directed
Arm Title
Vehicle foam
Arm Type
Placebo Comparator
Arm Description
Subjects will apply the assigned vehicle foam topically once daily for 12 weeks as directed
Intervention Type
Drug
Intervention Name(s)
FMX-101, 4% minocycline foam
Intervention Description
FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Vehicle Foam
Intervention Description
Vehicle foam applied topically once daily for 12 weeks
Primary Outcome Measure Information:
Title
Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12
Description
To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.
Time Frame
Baseline and Week 12
Title
Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12
Description
The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12
Description
To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Percent change from Baseline is calculated as the Baseline value minus the post-Baseline value divided by the baseline value, expressed as a percentage. Non-inflammatory lesions included: open comedones (blackhead) and closed comedones (whitehead).
Time Frame
Baseline and Week 12
Title
Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9
Description
To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.
Time Frame
Baseline, at Week 6 and at Week 9
Title
Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9
Description
The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline.
Time Frame
Baseline, at Week 6 and at Week 9
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and and Treatment-emergent Serious Adverse Events (TESAEs)
Description
To evaluate the safety compared to vehicle of topical FMX101 4% administered daily for 12 weeks and to evaluate the long-term safety of topical FMX101 4% administered daily for up to an additional 40 weeks. TEAEs of the double-blind phase were defined as AEs starting on or after date of first application of investigational product (IP), but before the date of the first application of the open-label phase, and AEs starting on or after the first application of the open-label phase are considered as TEAEs of the open-label phase.
Time Frame
Double blind: Screening Day until Week 12; Open-label: Week 16 until Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has facial acne vulgaris with:
20 to 50 inflammatory lesions (papules, pustules, and nodules);
25 to 100 noninflammatory lesions (open and closed comedones);
no more than 2 nodules on the face; and
IGA score of moderate (3) to severe (4)
Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin 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:
Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne) or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations
Sunburn on the face
Severe systemic disease, which might interfere with the conduct of the study or the interpretation of the results.
Abnormal baseline laboratory values that are considered clinically significant
Allergy to tetracycline-class antibiotics or to any ingredient in the study drug
Pseudomembranous colitis or antibiotic-associated colitis
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
City
Shelton
State/Province
Connecticut
ZIP/Postal Code
06484
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10012
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
City
Bridgeport
State/Province
West Virginia
ZIP/Postal Code
26330
Country
United States
City
San Cristobal
Country
Dominican Republic
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne
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