Maryland Dermatology, Laser, Skin and Vein Institute, Hunt Valley, Maryland.
Research Institute of SouthEast, West Palm Beach, Florida.
Dermatol Surg. 2021 Apr 1;47(4):527-532. doi: 10.1097/DSS.0000000000002856.
HARK was recently approved in the US for lip augmentation and correction of upper perioral rhytids.
To demonstrate noninferiority of HARK versus a control (HAJV) in lip fullness augmentation at Week 8 after last injection (blinded evaluation). Secondary objectives were to evaluate the effectiveness and safety of HARK in lip fullness augmentation and correction of upper perioral rhytids.
Treatment with HARK 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).
The primary objective was met; HARK 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 HARK injected was approximately 20% lower than control. Treatment-related adverse events and local tolerability symptoms were predominantly mild and transient.
HARK was noninferior to control in lip fullness augmentation at Week 8, well-tolerated, and effective throughout this 48-week study.
HARK 最近在美国获得批准，可用于丰唇和矫正上唇周围皱纹。
在末次注射后 8 周（盲法评估），证明 HARK 与对照（HAJV）在丰唇效果方面非劣效。次要目的是评估 HARK 在丰唇和矫正上唇周围皱纹方面的有效性和安全性。
在这项为期 48 周、评估者盲法的研究中，患者在第 1 天接受 HARK 或对照（随机 2:1）治疗，可选择在第 4 周进行补打。主要终点是从基线到第 8 周的唇部丰满度变化。次要终点包括唇部丰满度、皱纹严重程度、美学改善、患者满意度、不良事件和局部耐受性（患者日记条目）。
主要目标达成；HARK 在第 8 周的丰唇效果方面非劣效于对照。第 48 周时，唇部丰满度和皱纹严重程度持续改善，同时伴有较高的美学改善和患者满意度评分。HARK 的平均注射量比对照低约 20%。与治疗相关的不良事件和局部耐受症状主要为轻度和短暂。
HARK 在第 8 周的丰唇效果方面非劣效于对照，耐受性良好，在这项 48 周的研究中始终有效。
