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article imageDermal fillers approved for treatment of 'laugh lines'

By Tim Sandle     Dec 18, 2016 in Health
The U.S. Food and Drug Administration (FDA) has approved a new process for the sculpturing of a face to remove the so-called ‘laughter lines’ that are associated with ageing.
The new technology has been created by a company called Galderma, who develop several skin-health products. The new product is designed for nasolabial folds or "laugh lines", for people aged 21 or over. As the skin ages it loses the collagen that helps shape and support it, which causes wrinkles to deepen.
The product comes in two forms: Restylane Refyne, designed for the treatment of moderate to severe facial wrinkles and folds; and Restylane Defyne, which is to be used for the treatment of moderate to severe, deep facial wrinkles and folds.
The products, PharmPro reports, take the form of gels and in trials both products have been shown to last for up to one year, post-application. According to Steven Fagien, a oculoplastic surgeon who worked on the development: “these new products are flexible and are designed to meet different patient needs. I am excited to offer these next-generation hyaluronic acid (HA) dermal fillers in my practice."
The product is a type of dermal filler and the aim is for the skin to appear natural after treatment. As part of the development the product has undergone safety and efficacy testing.
Testing was based on two clinical trials using 171 and 162 subjects. The conclusion was that both products produced clinically meaningful improvement in wrinkle severity in the majority of the patients enlisted. The initial effects of the gel injection were mild or moderate.
The evaluation was based on the clinically recognized Wrinkle Severity Rating Scale (this is a five-point measure of the size and depth of the wrinkles.) Here grade one is defined as the absence of wrinkles whereas grade five refers to deep and long wrinkles. When the product was applied to the test subjects, a grade one improvement was reported with 79 percent of Restylane Refyne subject and with 77 percent of Restylane Defyne subjects.
More about dermal fillers, laughter lines, face filling, Skin
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