Atrophic ScarNCT06435884
Long-Term Follow-up of Adult With Atorpphic Scars Treated With TRTP-101
An observational study of Atrophic Scar, run by CellinCells at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrophic Scar
- How many people
- 3 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Sep 2024to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with Atropic Scars Treated with TRTP-101 in Sutdy CIC101-01
Who may be able to join
- Received TRTP-101 in clinical trial CIC101-01
- Provided written informed consent to participate in this study
Who cannot join
- Judged to be unsuitable to participate in this long-term follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Atrophic Scar
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Event
SAE will be collected
Measured: Up to 5 years
Secondary outcomes (2)
Mean percent change in atrophic scar volume
The depressed volume of atropic scar is measured at baseline in study CIC101-01
Measured: 6, 12, 18 and 24 months
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.
Measured: 6, 12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start6 Sep 2024
- Primary completionSep 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- CellinCells
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JongHee Lee, MD, Principal investigator, Department of Dermatology, Samsung Medical Center, Sungkyunkwan University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435884
- Sponsor's protocol ID
- CIC101-01-LT
- Status last verified
- Mar 2026
- First submitted
- 24 May 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-up of Adult With Atrophic Scars Treated With TRTP-101 in Study CIC101-01
- ClinicalTrials.gov ID
- NCT06435884
- Acronym / sponsor ID
- CIC101-01-LT
- Conditions
- Atrophic Scar
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3 participants (actual)
- Lead sponsor
- CellinCellsIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Atropic Scars Treated with TRTP-101 in Sutdy CIC101-01
Key inclusion criteria (2 listed)
- Received TRTP-101 in clinical trial CIC101-01
- Provided written informed consent to participate in this study
Key exclusion criteria (1 listed)
- Judged to be unsuitable to participate in this long-term follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serious Adverse Event
Time frame: Up to 5 years
SAE will be collected
2 secondary outcomes
Mean percent change in atrophic scar volume
Time frame: 6, 12, 18 and 24 months
Patient's Satisfaction
Time frame: 6, 12, 18 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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RecruitingObservational study
CIC101-02-LT is a Long-term Follow-up Study of Participants Treated With TRTP-101 and Will Evaluate the Long-term Safety and Efficacy of TRTP-101.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JongHee Lee, MD principal investigator
Department of Dermatology, Samsung Medical Center, Sungkyunkwan University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrophic Scar, run by CellinCells at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Event (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.