Joseph John H, Dayan Steven H, Bhatia Ashish C, Fabi Sabrina G, Shridharani Sachin M, Donofrio Lisa, Montes Jose R, Palm Melanie D, Liu Genzhou, Hernandez David, Edgecombe Jill, Vijayan Saji, Robinson Deanne Mraz
Private practice, Encino, California, USA.
University of Illinois at Chicago, Chicago, Illinois, USA.
J Cosmet Dermatol. 2023 Jan;22(1):177-185. doi: 10.1111/jocd.15451. Epub 2022 Oct 24.
Collagenase clostridium histolyticum-aaes (CCH-aaes) is approved in the United States for moderate-to-severe cellulite in the buttocks of adult women.
Interim analysis to evaluate efficacy/safety of CCH-aaes in the treatment of thigh cellulite.
Data were analyzed from a phase 3, open-label study (REAL). Women with mild-to-moderate cellulite on both thighs (Clinician Reported Photonumeric Cellulite Severity Scale score, 2 or 3) received ≤0.84 mg (volume, 18 ml) of CCH-aaes subcutaneously, in up to 12 dimples per posterolateral thigh, in up to 3 treatment sessions (Days 1, 22, and 43). Follow-up was on Day 90 (interim cutoff). A subset of women participated in the concurrent study (PIXELS), which included high-definition photography and 3D-image scanning of treatment areas.
Twenty-two women (44 thighs) were included in the interim analysis (mean age, 42.3 years; thighs with mild cellulite, 68.2%). Investigators reported high percentages of responders (score of "improved" or better on Investigator Global Aesthetic Improvement Scale) at Day 90 for either thigh (86.4%; primary endpoint) or both thighs (72.7%). Patient-reported bother due to cellulite was reduced at Day 90; mean change was 15.3 points (85.5% reduction) in BODY-Q Appraisal of Cellulite Scale total score (possible range, 11-44). In PIXELS analysis, Day 90 3D-image scans showed improvement from baseline in skin roughness in some of the treated thigh areas. The most commonly reported adverse events were injection-site bruising and pain (95.5% and 50.0% of patients, respectively).
CCH-aaes treatment of mild-to-moderate thigh cellulite was effective and generally well tolerated, with markedly reduced cellulite-related bother.
溶组织梭状芽孢杆菌胶原酶aaes（CCH-aaes）在美国被批准用于治疗成年女性臀部的中度至重度脂肪团。
进行中期分析，以评估CCH-aaes治疗大腿脂肪团的疗效和安全性。
分析了一项3期开放标签研究（REAL）的数据。双侧大腿有轻度至中度脂肪团的女性（临床医生报告的光子数字脂肪团严重程度量表评分为2或3），每侧大腿后外侧最多12个酒窝处皮下注射≤0.84mg（体积为18ml）的CCH-aaes，最多进行3次治疗（第1天、第22天和第43天）。在第90天进行随访（中期截止）。一部分女性参与了同期研究（PIXELS），其中包括对治疗区域进行高清摄影和3D图像扫描。
22名女性（44条大腿）纳入中期分析（平均年龄42.3岁；有轻度脂肪团的大腿占68.2%）。研究人员报告，在第90天，单条大腿（主要终点）或双侧大腿的反应者（根据研究者整体美学改善量表评分为“改善”或更好）比例很高（分别为86.4%和72.7%）。在第90天，患者报告的因脂肪团引起的困扰有所减少；在身体脂肪团评估量表总分（可能范围为11-44）中，平均变化为15.3分（降低85.5%）。在PIXELS分析中，第90天的3D图像扫描显示，部分治疗的大腿区域皮肤粗糙度较基线有所改善。最常报告的不良事件是注射部位瘀伤和疼痛（分别占患者的95.5%和50.0%）。
CCH-aaes治疗轻度至中度大腿脂肪团有效，且一般耐受性良好，与脂肪团相关的困扰明显减少。
