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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRTP-101 | Experimental | High-dose TRTP-101 |
|
| TRPT-101 (Low dose group) | Experimental | In a split-face design, low-dose TRTP-101 is administered to one side of the face and placebo to the contralateral side. |
|
| Placebo (Low dose group) | Placebo Comparator | In a split-face design, placebo is administered to one side of the face and low-dose TRTP-101 to the contralateral side. |
|
| TRPT-101 (High dose group) | Experimental | In a split-face design, high-dose TRTP-101 is administered to one side of the face and placebo to the contralateral side. |
|
| Placebo (High dose group) | Placebo Comparator | In a split-face design, placebo is administered to one side of the face and high-dose TRTP-101 to the contralateral side. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRTP-101 | Biological | Intradermal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| [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 | 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 | 12, 24 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| [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. | 12, 24 weeks after treatment |
| [Phase 2] Distribution of subjects by treatment satisfaction score |
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Inclusion Criteria:
[Phase 1]
[Phase 2]
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HyeJung Park | Contact | +82-70-4469-9115 | hjpark@cellincells.com |
| Name | Affiliation | Role |
|---|---|---|
| Jonghee Lee, MD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
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The Phase 1 study is conducted as an open-label trial, whereas the Phase 2 study is designed as a randomized, double-blind trial.
| Placebo | Biological | Intradermal injection |
|
Distribution of subjects by treatment satisfaction score at 12, 24 weeks after treatment, assessed using the Subject Acne Scar Self-Assessment Scale. |
| 12, 24 weeks after treatment |