An Interim 6-Month Analysis of the Dermatologic Effects and Midface Volume Correction With XTR CL Filler in a Prospective, Single-Center Study.

BACKGROUND: Hyaluronic acid-based filler injections with parenteral anesthetics have become the standard in treating midface volume deficits. There are currently limited data on the effects of these types of fillers on skin density, thickness, and firmness. OBJECTIVE: This study aimed to assess the efficacy of XTR CL filler in improving skin quality and tissue volume in women with midface volume loss. MATERIALS AND METHODS: In this prospective, noncomparative, single-center study, 50 women aged between 40 and 60 years with midface volume loss were recruited. The primary endpoint was the improvement in investigator-assessed Global Aesthetic Improvement Scores (GAIS) 1 month after treatment. Secondary endpoints include objective measurements of skin density, thickness, and quality measurements, facial and/or cheek volume augmentation, subjective GAIS, and device evaluation from after the first injection until 6 months, and the documentation of injection site reactions and adverse events. RESULTS: XTR CL use led to significant improvement in midface volume deficits, and skin quality and skin thickness. Injector and subject satisfaction with the treatment were documented and only mild-to-moderate adverse reactions were reported. CONCLUSION: XTR CL was shown to be effective in improving volume loss and skin quality at 6 months.

Safety and efficacy of a carboxymethyl chitosan dermal injection device for the treatment of skin defects: a first-in-man, pilot, comparative, split-body study.

Injectable soft-tissue devices are increasingly used for improving skin defects and deficiencies related to ageing. To assess the safety and efficacy of KIO015, a new injectable soft-tissue device formulated with carboxymethyl chitosan for the intradermal treatment of skin defects associated with ageing. Twenty-two subjects (40-65 years) were randomized to receive injections in the neckline of KIO015 and a non-cross-linked HA-based device, and were followed for up to 10 months. Injection site reactions (ISRs) and adverse events (AEs) were documented. Skin improvement was assessed instrumentally and clinically. Skin biopsies at injection zones in the lower back were taken at Day 28 for histopathology and immunohistochemistry analyses, to further assess product performance. Histomorphometric analyses on rabbits and in vitro assessment of KIO015 antioxidant capacity were also conducted. KIO015 was very well tolerated. Only expected and transient ISRs were observed; mainly erythema and hematoma. No adverse local effects or foreign body granuloma were observed histologically. Both clinical and instrumental evaluations confirmed the performance of KIO015. The skin was firmer and more elastic. Skin hydration showed significant improvement three days after injection. KIO015 exhibited superior overall maintenance of skin hydration after 10 months as compared to HA. These clinical results were supported by in vitro trials and implantation tests in the rabbit. The results from this pilot study support the use of KIO015 as an innovative alternative to HA-based devices for intradermal treatment of skin disorders.