A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris

Study Overview
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Brief Summary
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A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)

Detailed Description
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This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy over 12 weeks of FMX101 topical foam containing 4% minocycline compared to vehicle in the treatment of subjects with moderate-to-severe facial acne vulgaris. Qualified subjects will be randomized to receive 1 of the following 2 treatments: FMX101 4% minocycline foam Vehicle foam

Official Title
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A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: FMX101
* 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 non-inflammatory lesions (open and closed comedones) No more than 2 nodules on the face 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.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMX101, 4% minocycline foam<br>FMX101, 4% minocycline foam applied topically once daily for 12 weeks | Drug: FMX101<br>* FMX101, 4% minocycline foam<br>|
| Placebo Comparator: Vehicle foam<br>Vehicle foam applied topically once daily for 12 weeks | Drug: Vehicle Foam<br>* Vehicle Foam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12. | A decrease in the inflammatory lesion count from Baseline to Week 12. | 12 weeks | 
| Investigator Global Assessment (IGA) Treatment Success (Dichotomized as Yes/no) at Week 12, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12 |  | 12 weeks | 
| The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9 |  | 9 weeks | 
| The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6 |  | 6 weeks | 
| IGA Treatment Success (Dichotomized as Yes/no) at Week 6, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 6 |  | 6 weeks | 
| IGA Treatment Success (Dichotomized as Yes/no) at Week 9, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 9 |  | 9 weeks |