A Randomized, Comparator-Controlled Study of HARC for Cheek Augmentation and Correction of Midface Contour Deficiencies.
J Drugs Dermatol
; 20(9): 949-956, 2021 Sep 01.
Article
en En
| MEDLINE
| ID: mdl-34491026
ABSTRACT
BACKGROUND:
HARC is a soft and flexible hyaluronic acid filler containing lidocaine, manufactured using XpresHAn® technology, restoring natural-looking volume and soft contours.OBJECTIVES:
To evaluate safety and effectiveness of HARC for cheek augmentation and correction of midface contour deficiencies compared to a control product HAJV (hereafter referred to as Control). Primary objective was to demonstrate non-inferiority of HARC compared to the Control, by blinded evaluation of change from baseline in midface fullness 12 weeks after last injection, using a 4 grade midface volume scale (MMVS). MATERIALS ANDMETHODS:
Subjects over the age of 21 with loss of fullness in the midface area (MMVS score 2, 3, or 4) were randomized 21 to treatment with HARC(n=142) or Control (n=68). Optional touch-up was allowed after 4 weeks. Study assessments included MMVS, aesthetic improvement, subject satisfaction, and safety. Subjects were followed for 48 weeks.RESULTS:
Overall, most subjects were female (89%) and mean age was 53 years (range 24-80). Total mean volume injected was 4.3 mL for HARC and 4.9 mL for Control. Primary objective was met; mean change from baseline in MMVS score at week 12 -1.4 (HARC), -1.3 (Control), 95% CI -0.22, 0.06. HARC effectiveness was supported by a high degree of aesthetic improvement and subject satisfaction throughout 48 weeks. Related adverse events were generally mild and transient.CONCLUSIONS:
HARC was well tolerated and non-inferior to Control for correction of midface fullness at 12 weeks after last injection. Aesthetic improvement and subject satisfaction were high and lasted through week 48. J Drugs Dermatol. 2021;20(9)949-956. doi10.36849/JDD.6191.
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Base de datos:
MEDLINE
Asunto principal:
Envejecimiento de la Piel
/
Técnicas Cosméticas
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Rellenos Dérmicos
Tipo de estudio:
Clinical_trials
Idioma:
En
Revista:
J Drugs Dermatol
Asunto de la revista:
DERMATOLOGIA
Año:
2021
Tipo del documento:
Article