NCT06435884

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
44mo left

Started Sep 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Sep 2024Dec 2029

First Submitted

Initial submission to the registry

May 24, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 6, 2024

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

May 24, 2024

Last Update Submit

March 3, 2026

Conditions

Atrophic Scar

Outcome Measures

Primary Outcomes (1)

  • Serious Adverse Event

    SAE will be collected

    Up to 5 years

Secondary Outcomes (2)

  • Mean percent change in atrophic scar volume

    6, 12, 18 and 24 months

  • Patient's Satisfaction

    6, 12, 18 and 24 months

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Received TRTP-101 in clinical trial CIC101-01
  • Provided written informed consent to participate in this study

You may not qualify if:

  • Judged to be unsuitable to participate in this long-term follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Study Officials

  • JongHee Lee, MD

    Department of Dermatology, Samsung Medical Center, Sungkyunkwan University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2024

First Posted

May 30, 2024

Study Start

September 6, 2024

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

KR(1)