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

Dermatol Surg. 2014 Jun;40(6):652-7. doi: 10.1111/dsu.0000000000000006.

Abstract

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study

MeSH terms

  • Aged
  • Asian People
  • Biocompatible Materials / administration & dosage*
  • Biocompatible Materials / adverse effects
  • Cosmetic Techniques* / adverse effects
  • Dextrans / administration & dosage*
  • Dextrans / adverse effects
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Injections, Intradermal
  • Male
  • Middle Aged
  • Nasolabial Fold*
  • Patient Satisfaction
  • Republic of Korea
  • Skin Aging / drug effects*
  • Time Factors
  • Treatment Outcome

Substances

  • Biocompatible Materials
  • Dextrans