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A Study (Study 1) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea

Primary Purpose

Facial Papulopustular Rosacea

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
FMX103 minocycline foam 1.5%
Vehicle foam
Sponsored by
Vyne Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Facial Papulopustular Rosacea focused on measuring Topical Minocycline Foam, 2-Arm study, Inflammatory lesion counts, Investigator's Global Assessment score

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Moderate-to-severe rosacea (as per the IGA score) on the proposed facial treatment area consisting of:

    1. At least 15 and not more than 75 facial papules and pustules, excluding lesions involving the eyes and scalp;
    2. No more than 2 nodules on the face.
  2. Presence of or history of erythema and/or flushing on the face.

Exclusion Criteria:

  1. Presence of any skin condition and/or Excessive facial hair, on the face that would interfere with the diagnosis or assessment of rosacea.
  2. Moderate or severe rhinophyma, dense telangiectasia (score 3, severe), or plaque-like facial edema.
  3. History of hypersensitivity or allergy to minocycline, any other tetracycline, or of any other component of the formulation.
  4. Active ocular rosacea (eg, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.

Sites / Locations

  • Foamix Investigational Site #152
  • Foamix Investigational Site # 127
  • Foamix Investigational Site #155
  • Foamix Investigational Site #143
  • Foamix Investigational Site # 131
  • Foamix Investigational Site #156
  • Foamix Investigational Site #153
  • Foamix Investigational Site # 114
  • Foamix Investigational Site # 116
  • Foamix Investigational Site # 135
  • Foamix Investigational Site # 123
  • Foamix Investigational Site # 109
  • Foamix Investigational Site # 112
  • Foamix Investigational Site #150
  • Foamix Investigational Site #144
  • Foamix Investigational Site #149
  • Foamix Investigational Site #151
  • Foamix Investigational Site # 104
  • Foamix Investigational Site # 121
  • Foamix Investigational Site #154
  • Foamix Investigational Site # 125
  • Foamix Investigational Site # 142
  • Foamix Investigational Site # 124
  • Foamix Investigational Site # 118
  • Foamix Investigational Site # 139
  • Foamix Investigational Site # 138
  • Foamix Investigational Site # 102
  • Foamix Investigational Site # 115
  • Foamix Investigational Site # 110
  • Foamix Investigational Site # 107
  • Foamix Investigational Site # 137
  • Foamix Investigational Site # 103
  • Foamix Investigational Site # 120
  • Foamix Investigational Site # 140
  • Foamix Investigational Site # 130
  • Foamix Investigational Site # 133
  • Foamix Investigational Site #146
  • Foamix Investigational Site # 136
  • Foamix Investigational Site #145
  • Foamix Investigational Site # 111
  • Foamix Investigational Site # 119
  • Foamix Investigational Site # 101
  • Foamix Investigational Site # 128
  • Foamix Investigational Site #147
  • Foamix Investigational Site # 141
  • Foamix Investigational Site #157
  • Foamix Investigational Site # 129
  • Foamix Investigational Site # 105
  • Foamix Investigational Site # 106
  • Foamix Investigational Site # 122
  • Foamix Investigational Site # 117
  • Foamix Investigational Site #159
  • Foamix Investigational Site # 108
  • Foamix Investigational Site # 126

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FMX103 1.5%

Vehicle foam

Arm Description

Participants will apply the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.

Participants will apply the assigned vehicle foam topically once daily for 12 weeks as directed.

Outcomes

Primary Outcome Measures

The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. Change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count.
Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at Week 12
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear), and at least a 2-step improvement (decrease) from Day 0/Baseline.

Secondary Outcome Measures

Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at Week 12
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as a 2-grade improvement (decrease) in score at Week 12 compared to Day 0/Baseline. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.
The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at Week 12
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.
The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. The change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count.
Percentage of Participants Achieving IGA Treatment Success at Week 4 and Week 8
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Day 0/Baseline.
Number of Participants With Adverse Events (AEs)
To evaluate the tolerability and safety of topical minocycline foam applied once daily for 12 weeks. A treatment-emergent adverse events (TEAE) was defined as any AE with an onset date on or after the first application of study drug, and before to the last application of study drug plus 3 days, having been absent pre-treatment or worsening relative to the pre-treatment state.

Full Information

First Posted
April 27, 2017
Last Updated
January 27, 2021
Sponsor
Vyne Therapeutics Inc.
Collaborators
Premier Research Group plc
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1. Study Identification

Unique Protocol Identification Number
NCT03142451
Brief Title
A Study (Study 1) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea
Official Title
A Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam Compared to Vehicle in the Treatment of Facial Papulopustular Rosacea (FX2016-11)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 2, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
September 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vyne Therapeutics Inc.
Collaborators
Premier Research Group plc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objectives of this study are to determine the efficacy and safety of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea.
Detailed Description
This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy of FMX103 topical foam containing 1.5% minocycline compared to vehicle, in the treatment of participants with moderate-to-severe facial papulopustular rosacea. Qualified participants will be randomized in a 2:1 ratio (active:vehicle) to receive 1 of the following 2 treatments: FMX103 minocycline foam 1.5% Vehicle foam Participants will be assigned to 1 of 2 treatments according to the randomization schedule. Participants will apply (or have applied) the study drug topically once daily for 12 weeks as directed. Participants will be advised to use the study drug at approximately the same time each day. Both the Investigator and participant will be blinded to the study drug identity. Participants will return for visits at Weeks 1, 4, 6, 8, 10, and 12. Efficacy evaluations (inflammatory lesion counts and Investigator's Global Assessment [IGA] score) will be performed at Weeks 4, 8, and 12 during the study. Note: Originally the two studies FX2016-11 and FX2016-12 were combinedly presented in the protocol registration form under one NCT number (NCT03142451), and later separated since results were analyzed separately.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Papulopustular Rosacea
Keywords
Topical Minocycline Foam, 2-Arm study, Inflammatory lesion counts, Investigator's Global Assessment score

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
This is a double-blind study, with limited access to the randomization code. The randomization code will be held in confidence until after the study database is locked and a memo documenting the database lock has been issued. Every effort will be made to retain the integrity of the blind. When issued to the sites, the study drug will be identical in appearance for all participants, regardless of treatment assignment.
Allocation
Randomized
Enrollment
751 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FMX103 1.5%
Arm Type
Experimental
Arm Description
Participants will apply the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
Arm Title
Vehicle foam
Arm Type
Placebo Comparator
Arm Description
Participants will apply the assigned vehicle foam topically once daily for 12 weeks as directed.
Intervention Type
Drug
Intervention Name(s)
FMX103 minocycline foam 1.5%
Intervention Description
Dosage form description: Foam containing minocycline HCl 1.5%. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 7.5 mg (1.5% active) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime.
Intervention Type
Drug
Intervention Name(s)
Vehicle foam
Intervention Description
Dosage form description: Foam containing minocycline vehicle foam. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 0.0 mg (vehicle) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime.
Primary Outcome Measure Information:
Title
The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12
Description
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. Change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count.
Time Frame
Baseline and Week 12
Title
Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at Week 12
Description
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear), and at least a 2-step improvement (decrease) from Day 0/Baseline.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at Week 12
Description
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as a 2-grade improvement (decrease) in score at Week 12 compared to Day 0/Baseline. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.
Time Frame
Week 12
Title
The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at Week 12
Description
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.
Time Frame
Baseline and Week 12
Title
The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8
Description
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. The change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count.
Time Frame
Baseline, Week 4 and Week 8
Title
Percentage of Participants Achieving IGA Treatment Success at Week 4 and Week 8
Description
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Day 0/Baseline.
Time Frame
Week 4 and Week 8
Title
Number of Participants With Adverse Events (AEs)
Description
To evaluate the tolerability and safety of topical minocycline foam applied once daily for 12 weeks. A treatment-emergent adverse events (TEAE) was defined as any AE with an onset date on or after the first application of study drug, and before to the last application of study drug plus 3 days, having been absent pre-treatment or worsening relative to the pre-treatment state.
Time Frame
From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderate-to-severe rosacea (as per the IGA score) on the proposed facial treatment area consisting of: At least 15 and not more than 75 facial papules and pustules, excluding lesions involving the eyes and scalp; No more than 2 nodules on the face. Presence of or history of erythema and/or flushing on the face. Exclusion Criteria: Presence of any skin condition and/or Excessive facial hair, on the face that would interfere with the diagnosis or assessment of rosacea. Moderate or severe rhinophyma, dense telangiectasia (score 3, severe), or plaque-like facial edema. History of hypersensitivity or allergy to minocycline, any other tetracycline, or of any other component of the formulation. Active ocular rosacea (eg, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
Facility Information:
Facility Name
Foamix Investigational Site #152
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Foamix Investigational Site # 127
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Foamix Investigational Site #155
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Foamix Investigational Site #143
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Foamix Investigational Site # 131
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Foamix Investigational Site #156
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Foamix Investigational Site #153
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Foamix Investigational Site # 114
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Foamix Investigational Site # 116
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93405
Country
United States
Facility Name
Foamix Investigational Site # 135
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Foamix Investigational Site # 123
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Foamix Investigational Site # 109
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33757
Country
United States
Facility Name
Foamix Investigational Site # 112
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Foamix Investigational Site #150
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Facility Name
Foamix Investigational Site #144
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Foamix Investigational Site #149
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Foamix Investigational Site #151
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Foamix Investigational Site # 104
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Foamix Investigational Site # 121
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Foamix Investigational Site #154
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Foamix Investigational Site # 125
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Foamix Investigational Site # 142
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33406
Country
United States
Facility Name
Foamix Investigational Site # 124
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Foamix Investigational Site # 118
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Foamix Investigational Site # 139
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Foamix Investigational Site # 138
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Foamix Investigational Site # 102
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Foamix Investigational Site # 115
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Foamix Investigational Site # 110
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
Foamix Investigational Site # 107
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Foamix Investigational Site # 137
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Foamix Investigational Site # 103
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Foamix Investigational Site # 120
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Foamix Investigational Site # 140
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Foamix Investigational Site # 130
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Foamix Investigational Site # 133
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Foamix Investigational Site #146
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Foamix Investigational Site # 136
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Foamix Investigational Site #145
City
New York
State/Province
New York
ZIP/Postal Code
10155
Country
United States
Facility Name
Foamix Investigational Site # 111
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Foamix Investigational Site # 119
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Foamix Investigational Site # 101
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
Foamix Investigational Site # 128
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Foamix Investigational Site #147
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
Facility Name
Foamix Investigational Site # 141
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Foamix Investigational Site #157
City
Saint Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Foamix Investigational Site # 129
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
Foamix Investigational Site # 105
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Foamix Investigational Site # 106
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Foamix Investigational Site # 122
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Foamix Investigational Site # 117
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Foamix Investigational Site #159
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Foamix Investigational Site # 108
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Foamix Investigational Site # 126
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study (Study 1) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea

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