A Randomized, Comparator-Controlled Study of HARC for Cheek Augmentation and Correction of Midface Contour Deficiencies.
| Autor: | Jones D, Baumann L, Moradi A, Shridharani S, Palm M, Teller C, Taylor M, Kontis TC, Chapas A, Kaminer MS, Bank D, Beer K, Hooper D |
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| Jazyk: | angličtina |
| Zdroj: | Journal of drugs in dermatology : JDD [J Drugs Dermatol] 2021 Sep 01; Vol. 20 (9), pp. 949-956. |
| DOI: | 10.36849/jdd.6191 |
| Abstrakt: | 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 and Methods: Subjects over the age of 21 with loss of fullness in the midface area (MMVS score 2, 3, or 4) were randomized 2:1 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. doi:10.36849/JDD.6191. |
| Databáze: | MEDLINE |
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