To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris

Study Overview
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Brief Summary
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This is a randomized, multicenter, double-blind, vehicle-controlled, 2-arm study to evaluate the safety and efficacy in 12 weeks of FMX101 minocycline foam, 4%, compared to vehicle, in the treatment of subjects with moderate to severe facial acne vulgaris.

Detailed Description
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Qualified subjects will be randomized to receive 1 of the following 2 treatments: FMX101 4% minocycline foam Vehicle foam Subjects with qualifying lesion counts and Investigator's Global Assessments (IGA) of acne severity scores and will be assigned to 1 of 2 treatments according to the randomization schedule. Subjects will apply the assigned study drug topically once daily for 12 weeks as directed. Subjects will be advised to apply the study drug at approximately the same time each day, preferably in the evening at bedtime. Both the Investigator and subject will be blinded to the study drug identity. Subjects will return for visits at Weeks 1, 2, 4, 6, 8, and 12. At the discretion of the clinic staff, for the convenience of subjects or clinic staff, visits can be scheduled to occur 2 days before or after the nominal schedule date for the Weeks 1, 2, 4, 8 and 12 visits. Efficacy evaluations (acne lesion counts and IGAs) will be performed at each visit during the study.

Official Title
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A Phase 3, Multi-center, Randomized, Double-Blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of Topical Administration of Minocycline Hydrochloride Foam (4%) in the Treatment of Moderate-to-Severe Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: FMX101


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has completed and signed an appropriately administered Informed Consent Form (ICF) prior to any study-related procedures. Subjects less than 18 years of age (or as required by state law) must sign an Assent Form for the study and a parent or legal guardian must sign the ICF. 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
Interventional Model Description: Drug: FMX101 FMX101, 4% minocycline foam Drug: Vehicle Foam Vehicle Foam
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ILC | The efficacy assessments will inflammation lesion counts at week12 | Week12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment (IGA) | Severity of acne vulgaris assessed by Investigator Global Assessment (IGA) IGA Scale for Acne Vulgaris for study is 0-5, score 0 is clear and normal, and score 5 is very severe. | week 12 | 
| nILC | The efficacy assessments will non-inflammation lesion counts at baseline and week12 | week 12 | 
| ILC week4 | The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 4 | week 4 | 
| ILC week8 | The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 8 | week 8 | 
| Investigator Global Assessment (IGA) week4 | IGA Treatment Success at Week 4 IGA Scale for Acne Vulgaris for study is 0-5, score 0 is clear and normal, and score 5 is very severe. | Week 4 | 
| Investigator Global Assessment (IGA) week8 | IGA Treatment Success at Week 8 IGA Scale for Acne Vulgaris for study is 0-5, score 0 is clear and normal, and score 5 is very severe. | Week 8 |