## Protocol Section
### Identification Module
**NCT ID:** NCT06435884

**Brief Title:** Long-Term Follow-up of Adult With Atorpphic Scars Treated With TRTP-101

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

#### Organization Study ID Info
**ID:** CIC101-01-LT
#### Organization
**Class:** INDUSTRY
**Full Name:** CellinCells
### Status Module
#### Completion Date
**Date:** 2029-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2029-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** CellinCells

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Atrophic Scar

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 6

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** SAE will be collected

**Measure:** Serious Adverse Event

**Time Frame:** Up to 5 years

#### Secondary Outcomes

**Description:** The depressed volume of atropic scar is measured at baseline in study CIC101-01

**Measure:** Mean percent change in atrophic scar volume

**Time Frame:** 6, 12, 18 and 24 months

**Description:** 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.

**Measure:** Patient's Satisfaction

**Time Frame:** 6, 12, 18 and 24 months

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Minimum Age:** 19 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adults with Atropic Scars Treated with TRTP-101 in Sutdy CIC101-01

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hjpark@cellincells.com

**Name:** HyeJung Park, Director

**Phone:** 82-70-4469-9115

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Dermatology, Samsung Medical Center, Sungkyunkwan University School of Medicine

**Name:** JongHee Lee, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6160

- Name: Cicatrix

- Relevance: LOW

- As Found: Unknown

- ID: M4589

- Name: Atrophy

- Relevance: HIGH

- As Found: Atrophic

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001284

- Term: Atrophy

### Misc Info Module

- Version Holder: 2024-05-31
