Long-Term Follow-up of Adult With Atorpphic Scars Treated With TRTP-101

N/AActive Not RecruitingNCT06435884

CellinCells3 enrolled

Overview

CIC101-01-LT is a long-term follow-up study of subjects treated with TRTP-101 and will evaluate the long-term safety and efficacy of TRTP-101.

The long-term safety of TRTP-101 was evaluated by participants in the CIC101-01 clinical trial and followed up for 5 years for serious adverse events.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Atrophic Scar

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Received TRTP-101 in clinical trial CIC101-01 * Provided written informed consent to participate in this study Exclusion Criteria: * Judged to be unsuitable to participate in this long-term follow-up

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Serious Adverse Event

SAE will be collected

Time frame: Up to 5 years

Secondary Outcomes

Mean percent change in atrophic scar volume

The depressed volume of atropic scar is measured at baseline in study CIC101-01

Time frame: 6, 12, 18 and 24 months

Patient's Satisfaction

Patient's Satisfaction with treatment scored by a 100-mm VAS(Visual Analogie Scale). On this scale, 0 indicates no satisfaction and 100 indicate extreme satisfaction.

Time frame: 6, 12, 18 and 24 months

Data from ClinicalTrials.gov

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