A Prospective, Open-Label, Observational, Postmarket Study Evaluating VYC-17.5L for the Correction of Moderate to Severe Nasolabial Folds Over 12 Months. Issue 2 (February 2017)

• Record Type: Journal Article
• Authors: Sattler, Gerhard; Philipp-Dormston, Wolfgang G.; Van Den Elzen, Helga; Van Der Walt, Cornelius; Nathan, Myooran; Kolodziejczyk, Julia; Kerson, Graeme; Dhillon, Benjeev
• Is Part Of: Dermatologic surgery. Volume 43:Issue 2(2017)
• Publication Date: 2017-02
• Subjects: Skin -- Surgery -- Periodicals; Skin -- Diseases -- Surgery -- Periodicals; 617.477
• DOI: 10.1097/DSS.0000000000000939
• Languages: English
• ISSNs: 1076-0512

Abstract

Abstract : 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.