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

March 3, 2026 updated by: CellinCells

Long-Term Follow-up of Adult With Atrophic Scars Treated With TRTP-101 in Study CIC101-01

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults with Atropic Scars Treated with TRTP-101 in Sutdy CIC101-01

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious Adverse Event
Time Frame: Up to 5 years
SAE will be collected
Up to 5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CellinCells

Investigators

  • Principal Investigator: JongHee Lee, MD, Department of Dermatology, Samsung Medical Center, Sungkyunkwan University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2024

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

May 24, 2024

First Submitted That Met QC Criteria

May 24, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIC101-01-LT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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