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DOI 10.1097/dss.0000000000001960

Медицинская библиотека · Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] · 2019

Safe, Effective Chin and Jaw Restoration With VYC-25L Hyaluronic Acid Injectable Gel.

Ogilvie Patricia, Sattler Gerhard, Gaymans Frodo, Belhaouari Lakhdar, Weichman Barry M, Snow Sean, Chawla Smita, Abrams Steve, Schumacher Andrew

СтатьяМногоцентровое исследованиеРандомизированное исследованиеПеревод пока не подготовлен

Аннотация

BACKGROUND

VYC-25L, a hyaluronic acid soft-tissue filler with lidocaine, is designed to restore and create facial volume in the chin and jaw.

OBJECTIVE

To evaluate the safety and effectiveness of VYC-25L in subjects with chin retrusion.

METHODS

Adults with chin retrusion (145°-165° glabella-subnasale-pogonion facial angle) were randomized (3:1) to receive VYC-25L in the chin/jaw at study onset (treatment group) or 3 months later (control group). Primary effectiveness end point was mean change in facial angle from baseline at Month 3. Safety assessments included injection site responses (ISRs), recorded in a subject diary, and adverse events (AEs).

RESULTS

VYC-25L was administered to 119 subjects (treatment group: n = 90; control group: n = 29). Mean change in facial angle from baseline at Month 3 was significantly greater in the treatment versus control group (difference: 2.51°; p < .0001). Effectiveness was also demonstrated by the proportion of subjects with improved/much improved Global Aesthetic Improvement Scale scores and responses on FACE-Q Satisfaction and Psychological Well-Being Scales. Treatment benefit remained evident at Month 12. Common ISRs were firmness (95.8%), tenderness (95.8%), and swelling (91.6%). No serious treatment-related AEs were reported.

CONCLUSION

VYC-25L significantly improved glabella-subnasale-pogonion facial angle and was generally safe and well tolerated.

Для цитирования: Ogilvie Patricia, Sattler Gerhard, Gaymans Frodo, Belhaouari Lakhdar, Weichman Barry M, Snow Sean, Chawla Smita, Abrams Steve, Schumacher Andrew. Safe, Effective Chin and Jaw Restoration With VYC-25L Hyaluronic Acid Injectable Gel.. Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]. 2019. DOI: 10.1097/dss.0000000000001960.

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