Using New Autologous Tissue Filler Improved Nasolabial Folds-Single-Armed Pilot Study.

ABSTRACT

OBJECTIVE: To evaluate the clinical efficacy and safety of the new autologous tissue filler derived from autologous skin and hairs for correction of nasolabial folds. MATERIALS AND METHODS: The new injectable soft tissue filler is prepared from autologous fibroblasts and keratin gel. A total of 40 patients were enrolled in this single-armed pilot study, all of them received the new filler injection treatment for correction nasolabial folds. Following up with the patients, collection of their clinical features, including photographs, satisfaction, and information on adverse events at the 1st, 3rd, 6th, 12th, and 24th months after injection. The clinical efficacy of each patient was evaluated by masked evaluators and independent expert panels, based on the Wrinkle Severity Rating Scale (WSRS) at different time points after the injection. RESULTS: Thirty-two patients completed the 24-months follow-up, obtaining at least 93.8% improvement, and 75% of them had significantly improved. Base on the self-satisfaction assessment (SSA) indicated that all of them were satisfied with the results. No adverse effects of filler injection treatment were observed during the follow-up. CONCLUSIONS: The combination of autologous keratin and fibroblasts as a new tissue engineering soft tissue filler has shown safety and long-term efficiency in correcting nasolabial folds, with high satisfaction and desirable result. LEVEL OF EVIDENCE IV This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .