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

Phase 3

Completed

• Conditions: Facial Papulopustular Rosacea
• Interventions: Drug: Vehicle foam; Drug: FMX103 minocycline foam 1.5%

• Registration Number: NCT03142451
• Lead Sponsor: Vyne Therapeutics Inc.

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.

Study Timeline

• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-05
• Study Start: 2017-06-02
• Primary Completion: 2018-08-31
• Study Completion: 2018-09-28
• Disposition First Submitted: 2019-11-08
• Disposition First Submitted QC: 2019-11-08
• Disposition First Posted: 2019-11-13
• Results First Submitted: 2020-11-23
• Results First Submitted QC: 2020-11-23
• Results First Posted: 2020-12-17
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 751

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle foam	Vehicle foam	Participants will apply the assigned vehicle foam topically once daily for 12 weeks as directed.
FMX103 1.5%	FMX103 minocycline foam 1.5%	Participants will apply the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.

Primary Outcome Measures

Name	Time	Method
The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12	Baseline and 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	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

Name	Time	Method
Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at Week 12	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	Baseline and 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	Baseline, 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	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)	From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])	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.

Trial Locations

Locations (54)

Foamix Investigational Site #155; 🇺🇸 Los Angeles, California, United States

Foamix Investigational Site #144; 🇺🇸 Miami Lakes, Florida, United States

Foamix Investigational Site # 142; 🇺🇸 West Palm Beach, Florida, United States

Foamix Investigational Site # 124; 🇺🇸 West Palm Beach, Florida, United States

Foamix Investigational Site # 140; 🇺🇸 Warren, Michigan, United States

Foamix Investigational Site # 127; 🇺🇸 Fremont, California, United States

Foamix Investigational Site # 105; 🇺🇸 Johnston, Rhode Island, United States

Foamix Investigational Site # 106; 🇺🇸 Greenville, South Carolina, United States

Foamix Investigational Site # 122; 🇺🇸 Murfreesboro, Tennessee, United States

Foamix Investigational Site # 128; 🇺🇸 Dublin, Ohio, United States

Foamix Investigational Site # 119; 🇺🇸 Charlotte, North Carolina, United States

Foamix Investigational Site # 101; 🇺🇸 Bexley, Ohio, United States

Foamix Investigational Site #156; 🇺🇸 Oceanside, California, United States

Foamix Investigational Site # 141; 🇺🇸 Jenkintown, Pennsylvania, United States

Foamix Investigational Site # 112; 🇺🇸 Hialeah, Florida, United States

Foamix Investigational Site # 111; 🇺🇸 Stony Brook, New York, United States

Foamix Investigational Site # 129; 🇺🇸 Yardley, Pennsylvania, United States

Foamix Investigational Site #157; 🇺🇸 Saint Clair, Pennsylvania, United States

Foamix Investigational Site #153; 🇺🇸 San Diego, California, United States

Foamix Investigational Site # 114; 🇺🇸 San Diego, California, United States

Foamix Investigational Site #149; 🇺🇸 Miami, Florida, United States

Foamix Investigational Site #159; 🇺🇸 Houston, Texas, United States

Foamix Investigational Site # 108; 🇺🇸 San Antonio, Texas, United States

Foamix Investigational Site # 126; 🇺🇸 Salt Lake City, Utah, United States

Foamix Investigational Site # 133; 🇺🇸 Omaha, Nebraska, United States

Foamix Investigational Site #143; 🇺🇸 Northridge, California, United States

Foamix Investigational Site # 131; 🇺🇸 Oceanside, California, United States

Foamix Investigational Site # 135; 🇺🇸 Santa Ana, California, United States

Foamix Investigational Site # 123; 🇺🇸 Santa Monica, California, United States

Foamix Investigational Site #151; 🇺🇸 Miami, Florida, United States

Foamix Investigational Site # 109; 🇺🇸 Clearwater, Florida, United States

Foamix Investigational Site #150; 🇺🇸 Lake Worth, Florida, United States

Foamix Investigational Site # 104; 🇺🇸 Ormond Beach, Florida, United States

Foamix Investigational Site #154; 🇺🇸 Sweetwater, Florida, United States

Foamix Investigational Site # 139; 🇺🇸 Snellville, Georgia, United States

Foamix Investigational Site # 118; 🇺🇸 Alpharetta, Georgia, United States

Foamix Investigational Site # 138; 🇺🇸 New Albany, Indiana, United States

Foamix Investigational Site # 110; 🇺🇸 Beverly, Massachusetts, United States

Foamix Investigational Site # 107; 🇺🇸 Brighton, Massachusetts, United States

Foamix Investigational Site # 103; 🇺🇸 Fort Gratiot, Michigan, United States

Foamix Investigational Site # 130; 🇺🇸 Saint Joseph, Missouri, United States

Foamix Investigational Site #145; 🇺🇸 New York, New York, United States

Foamix Investigational Site # 136; 🇺🇸 New York, New York, United States

Foamix Investigational Site # 120; 🇺🇸 Troy, Michigan, United States

Foamix Investigational Site # 102; 🇺🇸 Metairie, Louisiana, United States

Foamix Investigational Site # 116; 🇺🇸 San Luis Obispo, California, United States

Foamix Investigational Site # 121; 🇺🇸 Sanford, Florida, United States

Foamix Investigational Site #146; 🇺🇸 Las Vegas, Nevada, United States

Foamix Investigational Site # 125; 🇺🇸 Tampa, Florida, United States

Foamix Investigational Site # 115; 🇺🇸 New Orleans, Louisiana, United States

Foamix Investigational Site # 137; 🇺🇸 Ann Arbor, Michigan, United States

Foamix Investigational Site # 117; 🇺🇸 Austin, Texas, United States

Foamix Investigational Site #152; 🇺🇸 Tucson, Arizona, United States

Foamix Investigational Site #147; 🇺🇸 Broomall, Pennsylvania, United States