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

Atrophic Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06435884
• Other study ID #: CIC101-01-LT
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: December 2029

Study information

• Verified date: May 2024
• Source: CellinCells
• Contact: HyeJung Park, Director
• Phone: 82-70-4469-9115
• Email: hjpark[@]cellincells.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6
• Est. completion date: December 2029
• Est. primary completion date: September 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophic Scar
• Atrophy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CellinCells

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Event	SAE will be collected	Up to 5 years
Secondary	Mean percent change in atrophic scar volume	The depressed volume of atropic scar is measured at baseline in study CIC101-01	6, 12, 18 and 24 months
Secondary	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.	6, 12, 18 and 24 months