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A Study (Study 2) 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 # 207
  • Foamix Investigational Site # 202
  • Foamix Investigational Site # 222
  • Foamix Investigational Site #244
  • Foamix Investigational Site #249
  • Foamix Investigational Site # 226
  • Foamix Investigational Site # 220
  • Foamix Investigational Site #251
  • Foamix Investigational Site # 217
  • Foamix Investigational Site #250
  • Foamix Investigational Site # 239
  • Foamix Investigational Site # 227
  • Foamix Investigational Site # 223
  • Foamix Investigational Site # 215
  • Foamix Investigational Site #245
  • Foamix Investigational Site # 240
  • Foamix Investigational Site #247
  • Foamix Investigational Site #252
  • Foamix Investigational Site # 214
  • Foamix Investigational Site #246
  • Foamix Investigational Site # 241
  • Foamix Investigational Site #248
  • Foamix Investigational Site # 204
  • Foamix Investigational Site # 211
  • Foamix Investigational Site # 225
  • Foamix Investigational Site #243
  • Foamix Investigational Site # 218
  • Foamix Investigational Site # 235
  • Foamix Investigational Site # 237
  • Foamix Investigational Site # 229
  • Foamix Investigational Site # 210
  • Foamix Investigational Site # 232
  • Foamix Investigational Site # 238
  • Foamix Investigational Site # 212
  • Foamix Investigational Site # 236
  • Foamix Investigational Site # 224
  • Foamix Investigational Site # 230
  • Foamix Investigational Site # 228
  • Foamix Investigational Site # 219
  • Foamix Investigational Site # 201
  • Foamix Investigational Site # 206
  • Foamix Investigational Site # 208
  • Foamix Investigational Site # 213
  • Foamix Investigational Site # 209
  • Foamix Investigational Site # 216
  • Foamix Investigational Site # 203

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.
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.
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. 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
October 20, 2020
Last Updated
December 16, 2020
Sponsor
Vyne Therapeutics Inc.
Collaborators
Premier Research Group plc
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1. Study Identification

Unique Protocol Identification Number
NCT04608500
Brief Title
A Study (Study 2) 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 (FX2016-12)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
July 2, 2018 (Actual)
Study Completion Date
July 31, 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
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
771 (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.
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.
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. 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 # 207
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Foamix Investigational Site # 202
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Foamix Investigational Site # 222
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Foamix Investigational Site #244
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Foamix Investigational Site #249
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Foamix Investigational Site # 226
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Foamix Investigational Site # 220
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Foamix Investigational Site #251
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Foamix Investigational Site # 217
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Foamix Investigational Site #250
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
Foamix Investigational Site # 239
City
Temecula
State/Province
California
ZIP/Postal Code
92592
Country
United States
Facility Name
Foamix Investigational Site # 227
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Foamix Investigational Site # 223
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Foamix Investigational Site # 215
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Foamix Investigational Site #245
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Foamix Investigational Site # 240
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Foamix Investigational Site #247
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Foamix Investigational Site #252
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33106
Country
United States
Facility Name
Foamix Investigational Site # 214
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Foamix Investigational Site #246
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Foamix Investigational Site # 241
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Foamix Investigational Site #248
City
Oldsmar
State/Province
Florida
ZIP/Postal Code
34677
Country
United States
Facility Name
Foamix Investigational Site # 204
City
Newnan
State/Province
Georgia
ZIP/Postal Code
78660
Country
United States
Facility Name
Foamix Investigational Site # 211
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Foamix Investigational Site # 225
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Foamix Investigational Site #243
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Foamix Investigational Site # 218
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Foamix Investigational Site # 235
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Foamix Investigational Site # 237
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Foamix Investigational Site # 229
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Foamix Investigational Site # 210
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Foamix Investigational Site # 232
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Foamix Investigational Site # 238
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Foamix Investigational Site # 212
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Foamix Investigational Site # 236
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Foamix Investigational Site # 224
City
Exton
State/Province
Pennsylvania
ZIP/Postal Code
19341
Country
United States
Facility Name
Foamix Investigational Site # 230
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Foamix Investigational Site # 228
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Foamix Investigational Site # 219
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Foamix Investigational Site # 201
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Foamix Investigational Site # 206
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Foamix Investigational Site # 208
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Foamix Investigational Site # 213
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Foamix Investigational Site # 209
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Foamix Investigational Site # 216
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Foamix Investigational Site # 203
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea

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