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

Recruiting

• Conditions: Atrophic Scar

• Registration Number: NCT06435884
• Lead Sponsor: CellinCells

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2024-05-24
• Study First Submitted QC: 2024-05-24
• Study First Posted: 2024-05-30
• Study Start: 2024-09-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-05
• Last Update Posted: 2024-10-08
• Primary Completion: 2029-09
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serious Adverse Event	Up to 5 years	SAE will be collected

Secondary Outcome Measures

Name	Time	Method
Mean percent change in atrophic scar volume	6, 12, 18 and 24 months	The depressed volume of atropic scar is measured at baseline in study CIC101-01
Patient's Satisfaction	6, 12, 18 and 24 months	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.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of