Study Evaluating Safety and Effectiveness of INNEA and INNEA AQUA Devices for Treating Wrinkles on Cheeks and Dcolletage in Women Aged 35 to 65

What this Trial Is About

Researchers are evaluating the performance and safety of two medical devices, INNEA and INNEA AQUA, for treating wrinkles on the cheeks and dcolletage in adult women aged 35 to 65 years. These devices are biodegradable dermal fillers made from different types of hyaluronic acid. The study aims to confirm the devices effects on skin aging signs, such as wrinkles and skin radiance, while monitoring safety. This is a post-market, single-arm, interventional clinical investigation. Participants will receive three intradermal injections of either INNEA or INNEA AQUA at one-week intervals. Treatments can be applied to the cheek, dcolletage, or both areas, using the same device for all three injections. The study includes a screening phase followed by five planned visits during which performance and safety assessments will be conducted. The treatments are delivered using sterile syringes and needles designed for intradermal injection. Throughout the study, researchers will collect demographic and medical history data and assess wrinkle improvement using the Lemperle Rating Scale for cheeks and the Global Aesthetic Improvement Scale for dcolletage and overall facial appearance. Participants will rate their skin radiance and firmness, and pain intensity after each injection will be recorded. Safety monitoring will include vital signs and skin reactions at each visit. Patient satisfaction will be evaluated with a 5-point Likert scale at the end of the study. The total participation period covers baseline and follow-up visits over approximately one month after the last injection.

Evaluation of Performance and Safety of INNEA and INNEA AQUA for the Treatment of Cheek and décolletage Wrinkles