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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
Samsung Medical Center
Seoul, South Korea
RECRUITING[Phase 1] Number of Subjects with Dose Limiting Toxicity
Dose Limiting Toxicity is defined as Grade ≥ 3 adverse drug reaction according to CTCAE criteria for 4 weeks after administration of TRTP-101
Time frame: within 4 weeks
[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.
Time frame: 12, 24 weeks after treatment
[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.
Time frame: 12, 24 weeks after treatment
[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.
Time frame: 12, 24 weeks after treatment
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