FDA Clears Sebacia Microparticles for Acne
The U.S. Food and Drug Administration has granted clearance for Sebacia Microparticles for the treatment of mild-to-moderate inflammatory acne. The gold microparticles are used with a 1,064nm laser to selectively target the sebaceous glands. The FDA clearance is based on results from a U.S. pivotal, randomized, controlled, blinded trial evaluating 168 patients with mild-to-moderate acne using either Sebacia Microparticles with laser or laser alone.
In this study, the Sebacia Microparticles treatment arm demonstrated a 53 percent median reduction in inflammatory lesion count, compared to 45 percent median reduction achieved by the laser treatment alone. The study achieved its primary endpoint of demonstrating non-inferiority at 12 weeks. It also achieved several secondary endpoints including 30.1 percent of patients treated with Sebacia Microparticles achieving a clear or almost clear IGA score (Investigator's Global Assessment of acne severity). All reported adverse events were of mild-to-moderate...
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