Department of Dermatology, Weill Cornell Medical College, Cornell University, New York, New York.
Cosmetic Laser Dermatology, San Diego, California.
Dermatol Surg. 2019 Aug;45(8):1047-1056. doi: 10.1097/DSS.0000000000001803.
Edematous fibrosclerotic panniculopathy (EFP; cellulite) is associated with thickening and contraction of collagen-rich subdermal septae. Collagenase clostridium histolyticum (CCH) may disrupt collagen-rich septae.
To evaluate the safety and efficacy of CCH for treatment of EFP.
In a randomized, double-blind study, women with moderate or severe EFP of the buttocks or posterolateral thighs (i.e., Clinician Reported Photonumeric Cellulite Severity Scale [CR-PCSS] and Patient Reported Photonumeric Cellulite Severity Scale [PR-PCSS] ratings of 3 to 4, and Hexsel Cellulite Severity Scale score ≤13) received up to 3 treatment sessions (Days 1, 22, and 43) of subcutaneous CCH 0.84 mg or placebo injections. End points included the percentage of 2-level and 1-level composite responders (i.e., had ≥2-level or ≥1-level improvement in CR-PCSS and PR-PCSS) at Day 71.
Three hundred seventy-five women (mean age, 46.5 years; 86.4% white) were randomly assigned to CCH (n = 189) or placebo (n = 186). At Day 71, the percentages of 2-level and 1-level composite responders were greater with CCH (10.6% and 44.6%, respectively) versus placebo (1.6% and 17.9%; p < .001 for both). The most common adverse events were injection-site related.
CCH significantly improved EFP appearance versus placebo; further evaluation of CCH for EFP (cellulite) is warranted.
水肿性纤维硬化性脂膜炎（EFP；蜂窝组织炎）与富含胶原蛋白的真皮下隔室增厚和收缩有关。胶原酶组织梭菌（CCH）可能会破坏富含胶原蛋白的隔室。
评估 CCH 治疗 EFP 的安全性和有效性。
在一项随机、双盲研究中，患有中度或重度臀部或后外侧大腿 EFP 的女性（即临床医生报告的光子数字脂肪团严重程度量表 [CR-PCSS] 和患者报告的光子数字脂肪团严重程度量表 [PR-PCSS] 评分为 3 到 4 分，以及 Hexsel 脂肪团严重程度量表评分≤13）接受多达 3 次（第 1、22 和 43 天）皮下注射 CCH 0.84 毫克或安慰剂。终点包括第 71 天 2 级和 1 级复合应答者（即 CR-PCSS 和 PR-PCSS 至少改善 2 级或 1 级）的百分比。
375 名女性（平均年龄 46.5 岁；86.4%为白人）被随机分配至 CCH（n=189）或安慰剂（n=186）组。第 71 天，CCH 组 2 级和 1 级复合应答者的比例分别为 10.6%和 44.6%，高于安慰剂组的 1.6%和 17.9%（均<0.001）。最常见的不良反应与注射部位有关。
与安慰剂相比，CCH 显著改善了 EFP 的外观；进一步评估 CCH 治疗 EFP（蜂窝组织炎）是合理的。
