A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne

Study Overview
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Brief Summary
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This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.

Official Title
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A Randomized, Double-Blind Study to Compare the Efficacy, Safety and Long-Term Safety of Topical Administration of FMX-101 for 1 Year in the Treatment of Moderate-to-Severe Acne Vulgaris, Study FX2014-04

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: FMX-101, 4% minocycline foam
* Drug: Vehicle Foam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has facial acne vulgaris with: 20 to 50 inflammatory lesions (papules, pustules, and nodules); 25 to 100 noninflammatory lesions (open and closed comedones); no more than 2 nodules on the face; and IGA score of moderate (3) to severe (4) Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin Cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study Exclusion Criteria: Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne) or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations Sunburn on the face Severe systemic disease, which might interfere with the conduct of the study or the interpretation of the results. Abnormal baseline laboratory values that are considered clinically significant Allergy to tetracycline-class antibiotics or to any ingredient in the study drug Pseudomembranous colitis or antibiotic-associated colitis

Ages Eligible for Study
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Minimum Age: 9 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: FMX-101, 4% minocycline foam<br>Subjects will apply the assigned FMX-101, 4% minocycline foam topically once daily for 12 weeks as directed | Drug: FMX-101, 4% minocycline foam<br>* FMX-101, 4% minocycline foam applied topically once daily for 12 weeks<br>|
| Placebo Comparator: Vehicle foam<br>Subjects will apply the assigned vehicle foam topically once daily for 12 weeks as directed | Drug: Vehicle Foam<br>* Vehicle foam applied topically once daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12 | To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules. | Baseline and Week 12 | 
| Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12 | The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline. | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12 | To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Percent change from Baseline is calculated as the Baseline value minus the post-Baseline value divided by the baseline value, expressed as a percentage. Non-inflammatory lesions included: open comedones (blackhead) and closed comedones (whitehead). | Baseline and Week 12 | 
| Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9 | To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules. | Baseline, at Week 6 and at Week 9 | 
| Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9 | The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline. | Baseline, at Week 6 and at Week 9 | 
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and and Treatment-emergent Serious Adverse Events (TESAEs) | To evaluate the safety compared to vehicle of topical FMX101 4% administered daily for 12 weeks and to evaluate the long-term safety of topical FMX101 4% administered daily for up to an additional 40 weeks. TEAEs of the double-blind phase were defined as AEs starting on or after date of first application of investigational product (IP), but before the date of the first application of the open-label phase, and AEs starting on or after the first application of the open-label phase are considered as TEAEs of the open-label phase. | Double blind: Screening Day until Week 12; Open-label: Week 16 until Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne