A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Split-Face, Phase 1/2 Study to Evaluate the Safety and Efficacy of a Single Administration of TRTP-101 in Adults With Atrophic Scars
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- CellinCells
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- [Phase 2] Proportion of subjects achieving ≥ 1-grade improvement from baseline in ASRS
研究概览
简要总结
The purpose of this clinical trial was to evaluate the safety and efficacy of a single administration of TRTP-101 in adults with atrophic scars.
详细描述
A phase 1 clinical trial designed to evaluate dose-limiting toxicity (DLT) following single-dose administration of TRTP-101 into four or more atrophic scar sites.
Subsequently, a phase 2 clinical trial will be conducted using a placebo-controlled, split-face design to evaluate the safety and efficacy of TRTP-101. Eligible subjects will have atrophic scars approximately 2 cm in diameter located on both sides of the face (e.g., the cheek or temple areas), and TRTP-101 and placebo will be administered to the respective sides of the face.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The Phase 1 study is conducted as an open-label trial, whereas the Phase 2 study is designed as a randomized, double-blind trial.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female aged greater than 19 years
- •Acne scars graded ≥ 3 on the 5-point ASRS
- •[Phase 1]
- •Four or more atrophic scars in the joints, genitals, perineum, and face except for the lips, eyes and nose
- •[Phase 2]
- •Atrophic scar lesions approximately 2 cm in diameter located on the cheeks or temple on both sides of the face
- •A response of "dissatisfied" or worse on the Subject Acne Scar Self-Assessment Scale
排除标准
- •History of cell therapy
- •Treatment of Dermal resurfacing, Chemical/Mechanical Peel and Skin Photorejuvenation
- •Treatment of Hyaluronic acid/collagen skin filler, non-permanent soft tissue filler and fat grafting
- •Positive for virus infection
- •Use of Anticoagulant therapy or NSAIDs
- •Thrombocytopenia or other coagulation disorder
- •History of keloid scars
- •Infectious disease or other dermatitis in the area of the atrophic scar
- •Use of Immunosuppressant, immunomodulating drug, anticancer drug or radiation therapy
- •Use of systemic steroid medication
- •History of hypersensitivity or severe allergic reactions (e.g., anaphylaxis, Guillain-Barre syndrome, etc.)
- •Use of retinoid medications
研究组 & 干预措施
TRPT-101 (High dose group)
In a split-face design, high-dose TRTP-101 is administered to one side of the face and placebo to the contralateral side.
干预措施: TRTP-101 (Biological)
Placebo (Low dose group)
In a split-face design, placebo is administered to one side of the face and low-dose TRTP-101 to the contralateral side.
干预措施: Placebo (Biological)
TRPT-101 (Low dose group)
In a split-face design, low-dose TRTP-101 is administered to one side of the face and placebo to the contralateral side.
干预措施: TRTP-101 (Biological)
Placebo (High dose group)
In a split-face design, placebo is administered to one side of the face and high-dose TRTP-101 to the contralateral side.
干预措施: Placebo (Biological)
TRTP-101
High-dose TRTP-101
干预措施: TRTP-101 (Biological)
结局指标
主要结局
[Phase 2] Proportion of subjects achieving ≥ 1-grade improvement from baseline in ASRS
时间窗: 12, 24 weeks after treatment
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 1] Number of Subjects with Dose Limiting Toxicity
时间窗: within 4 weeks
Dose Limiting Toxicity is defined as Grade ≥ 3 adverse drug reaction according to CTCAE criteria for 4 weeks after administration of TRTP-101
次要结局
- [Phase 2] Proportion of subjects achieving ≥ 1-grade improvement on the GAIS(12, 24 weeks after treatment)
- [Phase 2] Distribution of subjects by treatment satisfaction score(12, 24 weeks after treatment)