A Prospective, Open-Label, Observational, Postmarket Study Evaluating VYC-17.5L for the Correction of Moderate to Severe Nasolabial Folds Over 12 Months.

BACKGROUND: VYC-17.5L (17.5 mg/mL hyaluronic acid, 0.3% lidocaine) is a dermal filler intended for deep dermis injection for the treatment of skin depressions. OBJECTIVE: To evaluate 12-month effectiveness and safety of VYC-17.5L for the treatment of moderate/severe nasolabial folds (NLFs). METHODS: Subjects ≥18 years old with moderate/severe NLFs were recruited (N = 70). Injected volume was aimed at achieving optimum correction; top-up treatment was given at 2 weeks if needed. The primary endpoint was investigator-assessed change in NLF severity over 12 months using the validated photonumeric NLF Severity Scale. Secondary endpoints included investigator- and subject-assessed satisfaction and safety. Adverse events judged to be more severe or prolonged than routinely observed were recorded. RESULTS: Sixty-five subjects completed study requirements. Mean volume injected was 3.0 ± 1.0 mL for both NLFs combined. Significant improvement was maintained in investigator-assessed NLF severity at 12 months, and investigators and subjects reported high satisfaction with VYC-17.5L throughout the study. Two unexpected adverse events were reported: (1) redness, swelling, and decreased sensitivity (resolved after 4 days) and (2) swelling (resolved after 48 hours); neither event was serious or life threatening. CONCLUSION: VYC-17.5L is effective and well tolerated for the treatment of moderate to severe NLFs for 1 year.

A prospective, open-label, multicenter, observational, postmarket study of the use of a 15 mg/mL hyaluronic acid dermal filler in the lips.

Hyaluronic acid (HA)-based injectable fillers three-dimensionally restore the natural contours of the lips and perioral area, thereby reducing some signs of aging lips. To evaluate the short-term aesthetic impact of treatment with the HA dermal filler Juvéderm(®) VOLBELLA(®) with Lidocaine, formulated utilizing VYCROSS(™) technology, for enhancement or correction of asymmetry of the lips, evaluated using a patient-centric approach. Sixty-two subjects were enrolled in this study, conducted at two sites in Germany. Primary endpoints were satisfaction with improvement, look and feel of the lips, assessed by subject and physician at first visit and 4 weeks post-treatment. Immediately after injection at first visit, 83.6% of subjects were Extremely Satisfied, Very Satisfied or Satisfied with improvement in the lips, which increased to 94.1% and 93.0% of subjects with/without top-up treatment at follow-up, respectively. After injection at first visit, 61.7% of subjects rated the look and feel of their lips as Extremely Natural or Very Natural, which increased to 75.0% and 93.0% of subjects with/without top-up treatment, respectively. The HA dermal filler was associated with minimal discomfort, bruising or swelling of the lips; almost two-thirds of subjects (62%) returned to social engagements on the same day. The high degree of subject satisfaction with aesthetic improvement in the lips, as well as the natural look and feel, indicates that this HA dermal filler represents an effective treatment option for patients requiring lip enhancement.

A prospective, observational study of the volumizing effect of open-label aesthetic use of Juvéderm® VOLUMA® with Lidocaine in mid-face area.

INTRODUCTION: Juvéderm® VOLUMA® with Lidocaine is a hyaluronic acid (HA)-based injectable gel that is used to restore the volume of the face. This study was designed to assess the real-world effectiveness of this HA gel over 21 days when used for mid-face augmentation in normal, healthy subjects desiring aesthetic improvement. MATERIALS AND METHODS: This prospective, observational, single-arm, open-label post-marketing study enrolled 115 healthy subjects, from five European centers. The primary objective was to evaluate subject-reported satisfaction and experience of the treatment across a range of doses of Juvéderm® VOLUMA® with Lidocaine (1 ml/2 ml/combination), immediately after injection and 21 days post-treatment. RESULTS: Subject satisfaction questionnaire (SSQ) scores of Delighted or Happy were given by 95.6% of subjects immediately after injection, and by 93.7% of subjects at Day 21. Overall, subject and investigator satisfaction with cosmetic effect and smoothness was very positive. Pain was minimal; most subjects experienced only minor degrees of discomfort, and this was mainly related to the procedure itself. CONCLUSIONS: Juvéderm® VOLUMA® with Lidocaine was well accepted by both subjects and investigators, associated with high levels of satisfaction, was considered smooth and easy to use, and was well tolerated when used for the treatment of mid-face area volume enhancement.

A review of the metabolism of 1,4-butanediol diglycidyl ether-crosslinked hyaluronic acid dermal fillers.

BACKGROUND: Cosmetic procedures are growing ever more common, and the use of soft tissue fillers is increasing. Practicing physicians need to be aware of the biological behavior of these products in tissue to enable them to respond to any safety concerns that their patients raise. OBJECTIVES: To provide an overview of the metabolism of 1,4-butanediol diglycidyl ether (BDDE)-crosslinked hyaluronic acid (HA) dermal fillers and to examine the safety of the resulting byproducts. METHODS: A review of available evidence was conducted. RESULTS: After reaction with HA, the epoxide groups of BDDE are neutralized, and only trace amounts of unreacted BDDE remain in the product (<2 parts per million). When crosslinked HA, uncrosslinked HA, and unreacted BDDE degrade, they break down into harmless byproducts or into byproducts that are identical to substances already found in the skin. CONCLUSION: Clinical and biocompatibility data from longer than 15 years support the favorable clinical safety profile of BDDE-crosslinked HA and its degradation products. Given the strength of the empirical evidence, physicians should be confident in offering these products to their patients.

Metastatic ductal eccrine adenocarcinoma masquerading as an invasive ductal carcinoma of the male breast.

We report the case of a 38-year-old man with metastatic ductal eccrine adenocarcinoma (DEA) of the left breast responding to 5-flourouracil, epirubicin and cyclophosphamide (FEC) chemotherapy. He initially presented with a 2-week history of difficulty walking because of bilateral hip and lower back pain. Examination showed an ulcerating cutaneous mass over the left anterior chest wall, left axillary lymphadenopathy and tenderness over the spine. A punch biopsy of the breast lesion resulted in a diagnosis of metastatic invasive ductal carcinoma (IDC) of the breast. He received palliative radiotherapy to the spine and also received six cycles of FEC chemotherapy and was subsequently commenced on tamoxifen and ibandronate. There was a symptomatic and radiological response to the FEC chemotherapy. Referral was subsequently made to our institution where the original punch biopsy was reviewed. This showed tumor cells that were polygonal with darkly stained pleomorphic nuclei and abundant eosinophilic cytoplasm and were also localized to areas of fibrotic stroma containing eccrine glands and ducts but did not appear to involve mammary tissue. Immunohistochemical studies showed the tumors to be cytokeratin 7 and gross cystic disease fluid protein-15/prolactin inducible protein negative and estrogen receptor alpha positive. Both the morphological and the immunohistochemical characteristics of the tumor were consistent with a revised diagnosis of DEA rather than IDC. When last reviewed, the patient remains pain free and his disease stable 17 months after his original presentation. This case emphasizes the challenge in discriminating histopathologically between two rare tumors of the male breast, namely DEA and IDC. In addition, clinical response to FEC by metastatic DEA has not been previously documented, and this therapeutic regimen warrants further investigation.