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
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.


CONCLUSIONS
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.
*Department of Dermatology, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea; †Department of Dermatology, Kangwon National University Hospital, Kangwon University College of Medicine, Chuncheon, Korea; ‡Department of Dermatology, Uijeongbu St. Mary's Hospital, The Catholic University of Korea, Uijeongbu, Korea.
Soo Jung
SJ
Shin
Young
Y
Her
Dong Soo
DS
Yu
Chul Woo
CW
Kim
Sang Seok
SS
Kim
D000368:Aged; D044466:Asian People; D001672:Biocompatible Materials / Q000008:administration & dosage* / Q000009:adverse effects; D003357:Cosmetic Techniques / Q000009:adverse effects; D003911:Dextrans / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007271:Injections, Intradermal; D008297:Male; D008875:Middle Aged; D060052:Nasolabial Fold; D017060:Patient Satisfaction; D056910:Republic of Korea; D015595:Skin Aging / Q000187:drug effects*; D013997:Time Factors; D016896:Treatment Outcome
D001672:Biocompatible Materials; D003911:Dextrans