Bass Lawrence S, Kaufman-Janette Joely, Joseph John H, Kaminer Michael S, Clark James, Fabi Sabrina G, Gold Michael H, Katz Bruce E, Peddy Kappa, Schlessinger Joel, Young V Leroy, Hurley David, McLane Michael P, Vijayan Saji, Liu Genzhou, Davis Matthew W, Goldman Mitchel P
Bass Plastic Surgery PLLC, New York, N.Y.
Skin Associates of South Florida, Coral Gables, Fla.
Plast Reconstr Surg Glob Open. 2022 May 25;10(5):e4306. doi: 10.1097/GOX.0000000000004306. eCollection 2022 May.
Collagen-rich fibrous septae and subcutaneous adipose protrusions play a role in cellulite pathophysiology. Collagenase clostridium histolyticum-aaes (CCH-aaes) injection causes enzymatic release of septae to resolve cellulite depressions and create a skin smoothing effect. This analysis pooled data from two identically designed, phase-3, randomized, double-blind, placebo-controlled studies to examine the efficacy and safety of CCH-aaes.
Adult women with moderate/severe cellulite (3-4 on Clinician Reported Photonumeric Cellulite Severity Scale and Patient Reported Photonumeric Cellulite Severity Scale) on the buttocks received up to three treatment sessions (Days 1, 22, and 43) of subcutaneous CCH-aaes 0.84 mg or placebo per treatment area. Composite and individual component response (≥2-level or ≥1-level improvement from baseline in Patient Reported Photonumeric Cellulite Severity Scale and/or Clinician Reported Photonumeric Cellulite Severity Scale) and additional patient-reported outcomes were determined at Day 71.
Analysis included 424 CCH-aaes-treated and 419 placebo-treated women. CCH-aaes-treated women were 5.9 times more likely than placebo-treated women to be ≥2-level composite responders at Day 71 (odds ratio [95% confidence interval], 5.9 [2.2-15.4]; < 0.001). A significantly greater percentage of CCH-aaes-treated women versus placebo-treated women were ≥1-level composite responders at Day 71 (39.4% versus 14.6%; < 0.001). Subgroup analyses indicated no apparent impact of Fitzpatrick skin type category and baseline cellulite severity (moderate/severe) on CCH-aaes efficacy. An inverse relationship between age and CCH-aaes response was observed in those with a body mass index less than 32 kg per m. The most common adverse events with CCH-aaes were injection-site bruising and injection-site pain.
CCH-aaes treatment significantly improved moderate-to-severe buttock cellulite appearance and was generally well tolerated.
富含胶原蛋白的纤维间隔和皮下脂肪突出在橘皮组织的病理生理过程中起作用。注射溶组织梭状芽孢杆菌胶原酶-aaes（CCH-aaes）可使间隔酶解，从而消除橘皮组织凹陷并产生皮肤平滑效果。本分析汇总了两项设计相同的3期随机双盲安慰剂对照研究的数据，以检验CCH-aaes的疗效和安全性。
臀部有中度/重度橘皮组织（临床医生报告的橘皮组织严重程度量表和患者报告的橘皮组织严重程度量表评分为3 - 4）的成年女性，每个治疗区域接受多达三个疗程（第1天、第22天和第43天）的皮下注射0.84毫克CCH-aaes或安慰剂。在第71天确定综合和个体成分反应（患者报告的橘皮组织严重程度量表和/或临床医生报告的橘皮组织严重程度量表较基线改善≥2级或≥1级）以及其他患者报告的结局。
分析纳入了424名接受CCH-aaes治疗的女性和419名接受安慰剂治疗的女性。在第71天，接受CCH-aaes治疗的女性成为≥2级综合反应者的可能性是接受安慰剂治疗女性的5.9倍（优势比[95%置信区间]，5.9[2.2 - 15.4]；P<0.001）。在第71天，接受CCH-aaes治疗的女性中≥1级综合反应者的比例显著高于接受安慰剂治疗的女性（39.4%对14.6%；P<0.001）。亚组分析表明，菲茨帕特里克皮肤类型类别和基线橘皮组织严重程度（中度/重度）对CCH-aaes疗效无明显影响。在体重指数小于32千克/平方米的人群中，观察到年龄与CCH-aaes反应呈负相关。CCH-aaes最常见的不良事件是注射部位瘀伤和注射部位疼痛。
CCH-aaes治疗显著改善了中度至重度臀部橘皮组织外观，且总体耐受性良好。
