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
- 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
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
FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
Vehicle foam applied topically once daily for 12 weeks
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 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
NCT02815280
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 FX2014-05
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
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.
Detailed Description
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. The first 12 weeks of the study involves randomized, double-blind treatment with active FMX-101, 4% or matching vehicle. Subjects who successfully complete the 12-week double blind portion of the study will be offered the opportunity to continue in the trial for up to an additional 40 weeks (for a total of 1 year) and receive open-label treatment with FMX-101, 4%.
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
495 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FMX-101, 4% minocycline foam
Arm Type
Experimental
Arm Description
FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
Arm Title
Vehicle Foam
Arm Type
Placebo Comparator
Arm Description
Vehicle foam applied topically once daily for 12 weeks
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, Week 6 and 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, Week 6 and Week 9
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) 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: From Baseline 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
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
Facility Information:
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
City
Oceanside
State/Province
California
ZIP/Postal Code
92049
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
City
Crowley
State/Province
Louisiana
ZIP/Postal Code
70526
Country
United States
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Montclair
State/Province
New Jersey
ZIP/Postal Code
07042
Country
United States
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10458
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
City
Port Arthur
State/Province
Texas
ZIP/Postal Code
77640
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
City
Santo Domingo
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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