In:
Dermatologic Surgery, Ovid Technologies (Wolters Kluwer Health), Vol. 47, No. 4 ( 2021-04), p. 527-532
Abstract:
HA RK was recently approved in the US for lip augmentation and correction of upper perioral rhytids. OBJECTIVE To demonstrate noninferiority of HA RK versus a control (HA JV ) in lip fullness augmentation at Week 8 after last injection (blinded evaluation). Secondary objectives were to evaluate the effectiveness and safety of HA RK in lip fullness augmentation and correction of upper perioral rhytids. METHODS AND MATERIALS Treatment with HA RK or control (randomized 2:1) was administered on Day 1 in this 48-week, evaluator-blinded study with optional touch-up at Week 4. Primary endpoint was change from baseline to Week 8 in lip fullness. Secondary endpoints included lip fullness, wrinkle severity, aesthetic improvement, subject satisfaction, adverse events, and local tolerability (subject diary entries). RESULTS The primary objective was met; HA RK was noninferior to control in lip fullness augmentation at Week 8. Lip fullness and wrinkle severity improvement persisted at Week 48, and was accompanied by high aesthetic improvement and subject satisfaction scores. The mean volume of HA RK injected was approximately 20% lower than control. Treatment-related adverse events and local tolerability symptoms were predominantly mild and transient. CONCLUSION HA RK was noninferior to control in lip fullness augmentation at Week 8, well-tolerated, and effective throughout this 48-week study.
Type of Medium:
Online Resource
ISSN:
1076-0512
,
1524-4725
DOI:
10.1097/DSS.0000000000002856
Language:
English
Publisher:
Ovid Technologies (Wolters Kluwer Health)
Publication Date:
2021
detail.hit.zdb_id:
2020062-6
