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.


CONCLUSIONS
VYC-17.5L is effective and well tolerated for the treatment of moderate to severe NLFs for 1 year.
*Rosenpark Research, Darmstadt, Germany;†Cologne Dermatology, Köln, Germany;‡Elzen Kliniek, Noord-Holland, Netherlands;§Allergan, Ltd., Marlow, United Kingdom (former Allergan employees);‖Allergan plc, Irvine, California;¶Allergan plc, Marlow, United Kingdom.
Gerhard
G
Sattler
Wolfgang G
WG
Philipp-Dormston
Helga
H
Van Den Elzen
Cornelius
C
Van Der Walt
Myooran
M
Nathan
Julia
J
Kolodziejczyk
Graeme
G
Kerson
Benjeev
B
Dhillon
D000328:Adult; D000368:Aged; D000067548:Dermal Fillers / Q000008:administration & dosage* / Q000009:adverse effects; D004487:Edema / Q000139:chemically induced; D004890:Erythema / Q000139:chemically induced; D004954:Esthetics; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D060052:Nasolabial Fold; D017060:Patient Satisfaction; D011358:Product Surveillance, Postmarketing; D015595:Skin Aging / Q000187:drug effects*
D000067548:Dermal Fillers; C526061:Juvederm Ultra; D006820:Hyaluronic Acid