The purpose of this clinical trial was to evaluate the safety and tolerability for 12 weeks after one dose of TRTP-101 in adults with atrophic scars.
A phase 1 clinical trial to evaluate dose-limiting toxicity by administering a singe dose of TRTP-101 to each of the four sites of atrophic scar.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Intradermal injection of the each of four sites
Samsung Medical Center
Seoul, South Korea
Number of Participants 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
Mean percent change in atrophic scar volume
The depressed volume of atropic scar is measured at baseline and post-treatment visits
Time frame: 1, 4, 8 and 12 weeks
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