The Food and Drug Administration has granted clearance to “Sebacia Microparticles” for the treatment of acne vulgaris, for use with 1,064 nm lasers , according to a press release from Sebacia, the company developing the product.
The product, gold-coated silica microparticles, in a topical suspension, is cleared for use “as an accessory to 1064 nm lasers to facilitate photothermal heating of sebaceous glands for the treatment of mild to moderate inflammatory acne vulgaris,” the release said.
FDA clearance is based on a randomized, blinded, controlled trial of 168 patients with mild to moderate acne vulgaris, according to the company. Patients were treated with either laser and microparticles or with laser alone. The primary endpoint – noninferiority – was met with a median 53% reduction in inflammatory lesion count in the group receiving microparticles plus laser versus 45% in the laser-only group, at 12 weeks. All adverse events were mild to moderate, with none that were serious, the company statement said.