Silk Medical Aesthetics announced the results of a 44-patient feasibility study under an FDA-approved IDE clinical trial for its all-natural dermal filler, About Face by Nature. The dermal filler is designed to be biocompatible, biodegradable, and reversible for soft tissue augmentation. The 13-week results found a favorable safety profile with high patient satisfaction and clinically meaningful improvement in NLF severity. The company also announced FDA-approval to initiate an IDE for a 50-patient feasibility clinical trial to study the product for lip volume enhancement and fine lines around the mouth. At the end of the 13-week trial, no device-related adverse events were reported, and common injection site responses, such as discoloration, redness, swelling, pain, tenderness, lumps, bruising, and itching, occurred at low rates with most resolving within 2-weeks. Also 83.7 percent of patients had a clinically meaningful improvement in wrinkle severity with a mean improvement of 1.0 in the Wrinkle Severity Rating Scale (WSRS), and 100 percent of clinicians and patients reported improvement on the Global Aesthetic Improvement Scale (GAIS). The clinical trial continues to follow patients over the course of 12 months. Silk Medical Aesthetics has licensed Evolved by Nature's robust patent portfolio for hyaluronic acid and lidocaine with Activated Silk for use in injectable aesthetic medicine and is developing the next-generation dermal filler platform to address all needs in volume restoration and the enhancement of the skin's look and feel. "Activated Silk, made from pure silk protein, is the first technology to advance biomaterials for dermal fillers since the introduction of HA and lidocaine," says Dr. Greg Altman, CEO and co-founder of Evolved by Nature, sister company to Silk Medical Aesthetics. "It can create products that outperform and redefine current benchmarks, and our current clinical results show we are well on our way."
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