自体脂肪来源间充质干细胞疗法在成人萎缩性瘢痕中的安全性和有效性

实验性的：TRTP-101

高剂量 TRTP-101

生物：TRTP-101

皮内注射

实验性的：TRPT-101（低剂量组）

在分脸设计中，低剂量TRTP-101被施用于面部一侧，而安慰剂则施用于对侧。

生物：TRTP-101

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安慰剂比较：安慰剂（低剂量组）

在分脸设计中，安慰剂施用于面部一侧，低剂量TRTP-101施用于对侧。

生物：安慰剂

皮内注射

实验性的：TRPT-101（高剂量组）

在分脸设计中，将高剂量TRTP-101施用于面部一侧，而将安慰剂施用于对侧。

生物：TRTP-101

皮内注射

安慰剂比较：安慰剂（高剂量组）

采用分脸设计，一侧面部施用安慰剂，对侧面部施用高剂量TRTP-101。

生物：安慰剂

皮内注射

[第一阶段] 发生剂量限制性毒性的受试者数量

剂量限制性毒性定义为根据CTCAE标准，在给予TRTP-101后4周内发生≥3级的不良药物反应

[Phase 2] Proportion of subjects achieving ≥ 1-grade improvement from baseline in ASRS

Proportion of subjects with ≥ 1-grade improvement from baseline in ASRS (Acne Scar Rating Scale) at 12, 24 weeks after treatment, as assessed by independent reviewers using a standardized photoguide

*The Acne Scar Rating Scale (ASRS) is a 5-grade scale ranging from 0 to 4 (0 = Clear, 1 = Very mild, 2 = Mild, 3 = Moderate, and 4 = Severe). Higher grades indicate greater severity of atrophic scars and therefore a worse outcome.

[Phase 2] Proportion of subjects achieving ≥ 1-grade improvement on the GAIS

Proportion of subjects with ≥ 1-point improvement from baseline on the GAIS (Global Aesthetic Improvement Scale) at 12, 24 weeks after treatment, as assessed by independent reviewers.

*The Global Aesthetic Improvement Scale (GAIS) is a 5-grade scale ranging from -1 to 3 (-1 = Worse, 0 = No change, 1 = Improved, 2 = Much improved, and 3 = Very much improved). Higher grades indicate greater aesthetic improvement and therefore a better outcome.

[Phase 2] Distribution of subjects by treatment satisfaction score

Distribution of subjects by treatment satisfaction score at 12, 24 weeks after treatment, assessed using the Subject Acne Scar Self-Assessment Scale.

*The Subject Acne Scar Self-Assessment Scale is a 5-grade scale ranging from -2 to +2 (-2 = Very dissatisfied, -1 = Dissatisfied, 0 = Somewhat satisfied, +1 = Satisfied, and +2 = Very satisfied). Higher grades indicate greater satisfaction with acne scars and therefore a better outcome.