Georgia Nelson Could this natural, biodegradable filler alternative be the future of aesthetics?
The results have been announced for a 44-patient study for a new all-natural dermal filler developed by US-based company Silk Medical Aesthetics with sister company Evolved by Nature. The FDA-approved 13-week trial found that the new injectable has a favourable safety profile with high patient satisfaction and clinically meaningful improvement in Nasolabial Folds (NLFs) severity.
Formulated with the company’s patented Activated Silk™ biotechnology, the filler is biocompatible, biodegradable and reversible for soft tissue augmentation.
“Activated Silk, made from pure silk protein, is the first technology to advance biomaterials for dermal fillers since the introduction of HA and lidocaine,” said Dr. Greg Altman, CEO & Co-Founder of Evolved by Nature. “It can create products that outperform and redefine current benchmarks, and our current clinical results show we are well on our way.”
At the 13-week primary endpoint in the NLF feasibility clinical trial, no device-related adverse events were reported, and common injection site responses, including redness, swelling, pain, tenderness, bruising, and itching, were minimal with most resolving within 2-weeks. At 13 weeks, 83.7 per cent of patients had a clinically meaningful improvement in wrinkle severity with a mean improvement of 1.0 in the Wrinkle Severity Rating Scale and 100 per cent of clinicians and patients reported improvement on the Global Aesthetic Improvement Scale. The study will continue to follow patients over the next 12 months.
This all-natural approach to dermal filler offers a more sustainable approach to aesthetics, minimising the amount of beauty and personal care products used to achieve desired results and saving the billions of units of plastic packaging discarded each year.
Following the initial results, the company will now conduct an FDA-approved 50-patient feasibility clinical trial to study the product for lip volume enhancement and fine lines around the mouth.
Silk Medical Aesthetics has licensed Evolved by Nature’s patent portfolio for hyaluronic acid and lidocaine with Activated Silk for use in injectable aesthetic medicine. The company is now developing the injectable for commercial use to address all needs in volume restoration and the enhancement of the skin’s look and feel. It is expected to become available for use in the US and EU as early as 2023.
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