Pivotal Study of Sebacia Microparticles in the Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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Prospective, randomized multicenter study to examine the safety and effectiveness of Sebacia microparticles with or without laser in the treatment of moderate to moderately-severe inflammatory acne vulgaris

Official Title
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A Randomized, Prospective, Multicenter, Controlled Study With Blinded Assessment to Determine the Safety and Effectiveness of the Sebacia Acne Treatment System in the Treatment of Inflammatory Acne Vulgaris

Conditions
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Inflammatory Acne Vulgaris

Intervention / Treatment
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* Device: Sebacia microparticles and laser
* Device: Vehicle suspension and laser
* Device: Sebacia microparticles without laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, 15 - 45 years of age Able to provide informed consent/assent; minors will provide assent while parent or legal guardian will provide consent Moderate to moderately severe (3 or 4) inflammatory acne vulgaris by Investigator's Global Assessment Subject has 25 to 75 inflammatory lesions on the cheeks, chin and forehead, not concentrated in one area Subject has Fitzpatrick skin phototype I, II or III Subject is in good health, willing to participate and able to comply with protocol requirements Exclusion Criteria: Severe acne (Investigator's Global Assessment 5) with significant scarring potential and greater than 2 nodular lesions Clinically relevant history of keloids Facial tattoos Acne conglobata, acne fulminans, chloracne, drug-induced acne Active concomitant skin disease, excessive scarring or excess facial hair Heavily tanned skin; unable or unwilling to avoid tanning beds/excessive sun exposure Acne medication and therapy restrictions - time period prior to Baseline (below) Oral retinoids - 6 months Other systemic medications - 4 weeks Topical retinoids, steroids, antibiotics - 2 weeks OTC topical treatments - 1 week Light treatments (including IPL or laser), microdermabrasion and/or peels - 8 weeks Investigational drug, biologic or device - 30 days Gold therapy of any type for any reason - EXCLUDED Pregnant, lactating, nursing or planning to become pregnant during the study period Known allergy to gold, ethanol, diisopropyl adipate, Polysorbate 80 Clinically relevant condition that makes participation unsafe or that would interfere with study treatment and assessment

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 35 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sebacia microparticles and laser<br>Gold microparticle suspension + laser treatment x 3 over the course of two weeks | Device: Sebacia microparticles and laser<br> <br> |
| Experimental: Vehicle suspension and laser<br>Vehicle suspension + laser treatment x 3 over the course of two weeks | Device: Vehicle suspension and laser<br> <br> |
| Experimental: Sebacia microparticles without laser<br>Gold microparticle suspension treatment x 3 over the course of two weeks | Device: Sebacia microparticles without laser<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percent change in inflammatory lesion count from Baseline to Week 12 |  | Week 12 | 
| Number of of adverse events |  | Screening to 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean absolute change in inflammatory lesion count from Baseline to Week 12 |  | Week 12 | 
| Success by Investigator's Global Assessment at Week 12 (defined as 2-point decrease from Baseline IGA) |  | Week 12 |