Twenty-Four-Week Multicenter, Evaluator-Blinded Clinical Study of the Efficacy and Safety of a Dextran Filler in the Treatment of Nasolabial Folds

초록

BACKGROUND Cross-linked dextran shows complete degradation in the vital tissue and has characteristics of neocollagenesis. However, its efficacy as a dermal filler in treating facial soft tissue defects has not been investigated. OBJECTIVE To evaluate the efficacy and safety of subcutaneous injection of a dextran filler in treating nasolabial folds for 24 weeks. METHODS AND MATERIALS Twenty patients were enrolled in this 24-week multicenter, evaluator-blinded clinical study. Each patient received a single session of a dextran filler treatment in both nasolabial folds, and no touch-up injections were given. Treatment efficacy was evaluated by blinded investigators at 4, 12, and 24 weeks after baseline. Safety data were collected from patient diaries and interviews at each follow-up visit. RESULTS There were significant improvements (p<.0001) in the Wrinkle Severity Rating Scale scores compared with those at baseline with a mean decrease of 1.50 +/- 0.51 at 24 weeks. Only 1 mild treatment-related adverse event was noted throughout the 24-week follow-up period. CONCLUSION Cross-linked dextran-derived injectable filler is considered to be a favorable measure in tissue augmentation of the nasolabial folds. Further investigation is needed to demonstrate the long-term efficacy and safety of dextran fillers.

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