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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Facial Papulopustular Rosacea

Intervention / Treatment
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* Drug: FMX103 minocycline foam 1.5%
* Drug: Vehicle foam


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMX103 1.5%<br>Participants will apply the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed. | Drug: FMX103 minocycline foam 1.5%<br>* 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.<br>|
| Placebo Comparator: Vehicle foam<br>Participants will apply the assigned vehicle foam topically once daily for 12 weeks as directed. | Drug: Vehicle foam<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure. | 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. 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. | Baseline, Week 4 and Week 8 | 
| 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 | 
| 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]) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Topical Minocycline Foam, 2-Arm study, Inflammatory lesion counts, Investigator's Global Assessment score