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

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)

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.

Study Overview

• Status: Completed
• Conditions: Facial Papulopustular Rosacea
• Intervention / Treatment: Drug: FMX103 minocycline foam 1.5%; Drug: Vehicle foam

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.

• Study Type: Interventional
• Enrollment (Actual): 771
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: FMX103 1.5%; Participants will apply the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.	Drug: FMX103 minocycline foam 1.5%; 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.
PLACEBO_COMPARATOR: Vehicle foam; Participants will apply the assigned vehicle foam topically once daily for 12 weeks as directed.	Drug: Vehicle foam; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 12
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.	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 4 and Week 8
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.	Week 12
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.	Baseline and Week 12
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.	Baseline, Week 4 and Week 8
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.	From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])

Collaborators and Investigators

• Sponsor: Vyne Therapeutics Inc.
• Collaborators: Premier Research Group plc

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ACTUAL): July 2, 2018
• Study Completion (ACTUAL): July 31, 2018

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (ACTUAL): October 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 7, 2021
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Topical Minocycline Foam; 2-Arm study; Inflammatory lesion counts; Investigator's Global Assessment score
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Disease Attributes; Rosacea; Facies; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: FX2016-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No