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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06435884

Enrollment

Registered

2024-05-30

Start date

2024-09-06

Completion date

2029-12-01

Last updated

2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophic Scar

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Serious Adverse Event	Up to 5 years	SAE will be collected

Secondary

Measure	Time frame	Description
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.

Countries

South Korea

Contacts

PRINCIPAL_INVESTIGATORJongHee Lee, MD

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

Outcome results