Twenty-four-week multicenter, evaluator-blinded clinical study of the efficacy and safety of a dextran filler in the treatment of nasolabial folds.

[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.