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.

Safety and efficacy of a novel injectable filler in the treatment of nasolabial folds: polymethylmethacrylate and cross-linked dextran in hydroxypropyl methylcellulose.

Nasolabial folds are a sign of aging and increasing number of people want filler injections in their nasolabial folds to look younger. Various dermal fillers are used for the correction of nasolabial folds. Recently, a novel injectible filler, polymethylmethacrylate (PMMA) and cross-linked dextran in hydroxypropyl methylcellulose, was introduced for facial contouring. This study was designed as a six-month, prospective, single-blinded, and open-label study in two centers located in Korea. Nineteen Korean patients received the novel filler injections on both nasolabial folds. At Weeks 4, 12, and 24, the efficacy and safety of the dermal filler were evaluated by blinded-investigators using clinical photographs. The mean Wrinkle Severity Rating Scale revealed significant decrease after dermal filler injections at each study visit. The decreased Wrinkle Severity Rating Scale was maintained for 6 months (p < 0.0001). The Global Aesthetic Improvement score showed an improvement greater than 2 in 95% of the per-proto col population 24 weeks after the injections. All patients (100%) experienced an improvement of their nasolabial folds at Week 24. There were no complications related to the novel filler injection. The novel dermal filler, PMMA, and cross-linked dextran in hydroxylpropyl methylcellulose, can be another safe and effective treatment option in the treatment of nasolabial folds.

Histology of a novel injectable filler (polymethylmethacrylate and cross-linked dextran in hydroxypropyl methylcellulose) in a rat model.

A novel injectable filler of polymethylmethacrylate (PMMA) and cross-linked dextran in hydroxypropyl methylcellulose was introduced in the commercial filler market. For soft tissue augmentation, safety and biocompatibility should be evaluated and the stability at the implantation site should be assessed using histologic evaluation. In order to evaluate the biocompatibility of the novel soft tissue filler, PMMA and cross-linked dextran in hydroxypropyl methylcellulose was subdermally injected into the skin of Sprague-Dawley Rats. Histologic evaluation was performed at 13 weeks and 12 months after the injection. Inflammatory cell infiltration, neovascularization, and fibrosis were scored according to defined grading systems. The mean score of the histologic evaluation was 5.7 and 3.9 at 13 weeks and 12 months, respectively. At 12 months after injection, the PMMA and cross-linked dextran in hydroxypropyl methylcellulose appeared to be kept in place through fine fibrous capsules. The mixture of PMMA and cross-linked dextran in hydroxypropyl methylcellulose can be safely applied for soft tissue augmentation with longevity of greater than 12 months.

Effects of crosslinked dextran in hydroxylpropyl methylcellulose on soft tissue augmentation in rats.

This study compared crosslinked dextrans in hydroxylpropyl methycellulose (DiHMs, pH 5 or 7) with polymethylmethacrylate in bovine collagen (PMMA) and hyaluronic acid (HA) fillers on soft tissue augmentation and safety in rats. HA tended to maintain its size throughout the experimental period but was moveable and friable because of a lack of thick fibroconnective tissue formation. Although, PMMA induced moderately thick fibroconnective tissue formation, its size was decreased markedly from 3-week postimplantation (PI) and became the smallest at 24-month PI. DiHM (pH 7) elicited strong fibrous encapsulation around the filler. Its size decreased slowly but was still considerably maintained at 24-month PI. In contrast, the rate of the DiHM (pH 5) size decrease was slower than that of PMMA, faster DiHM (pH 7), but comparable to HA. Immunohistochemically, types I and III collagens were deposited inside and outside DiHMs (pH 5 and 7). DiHMs (pH 5 and 7), PMMA, and HA showed no adverse reactions. These results suggest that DiHM (pH 7) assures efficacy and safety and is a good candidate for soft tissue augmentation in both humans and animals.