KeloidsNCT07413497
A Prospective Observational Clinical Study on Exploring the Value of Surgical Excision Combined With 32P Application in the Treatment of Keloids and the Factors Affecting the Prognosis of Combined Therapy
An observational study of Keloids and Keloids Scars, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
Keloids are non-cancerous (benign) growths on the skin. They form after an injury, when the skin makes too much connective tissue that thickens and hardens. These keloids cause big problems for people. They grow uncontrollably on their own, itch, hurt, and look bad. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Keloids, Keloids Scars
- How many people
- 401 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2030
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will be conducted in patients diagnosed with keloids who meet the surgical indications. Investigators or designated personnel must ensure that only patients who meet all the following inclusion criteria and have no exclusion criteria are enrolled in the study.
Who may be able to join
- Histological biopsy confirms the patient has keloids. Pathological diagnostic criteria include: 1. Proliferating fibroblasts: A large number of proliferating fibroblasts are usually detected in keloid tissue. 2. Disordered arrangement of collagen fibers: Collagen fibers in normal scars are generally arranged in an orderly manner, while in keloids, they are disorganized and present as thick bundles. 3. Scar tissue extending beyond the original wound boundaries: Keloid tissue often spreads beyond the scope of the initial trauma.
- Patients with keloids ≥3 mm in thickness and within 1 week after surgical excision.
- Patients have at least one measurable lesion as defined by the Vancouver Scar Scale (VSS) criteria.
- Patients have no other skin disorders similar to keloids.
- Patients are capable of understanding and signing the informed consent form.
- Patients are willing and able to comply with scheduled visits, treatment plans, laboratory tests, follow-up appointments, and other study procedures.
Who cannot join
- Difficulty in accurately assessing the patient's lesions.
- Patients who do not meet the indications for local excision or have received superficial radiotherapy after surgery.
- Dementia, intellectual impairment, or any mental illness that hinders the understanding of the informed consent form.
- Patients deemed inappropriate to participate in this clinical study by the investigator.
- Patients from whom pathological specimens cannot be obtained, or those who die or are lost to follow-up.
- Patients with recurrent keloids following previous treatment.
- Pregnant female patients. -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jiachen Liu contact
About this study
Keloids are non-cancerous (benign) growths on the skin. They form after an injury, when the skin makes too much connective tissue that thickens and hardens.
These keloids cause big problems for people. They grow uncontrollably on their own, itch, hurt, and look bad. This is especially true if they're on visible areas like the head or neck-they harm both a person's physical comfort and mental well-being.
Read more
32P application is a popular treatment for keloids. It's simple, easy to use, quick, and doesn't have many limits on where or when it can be used. Besides keloids, it also works for surface skin issues like hemangiomas.
Here's how 32P works: When it breaks down (decays), it releases beta rays. These rays create a local effect that changes the shape and function of the affected tissue. Blood vessel cells in the area swell, get inflamed, and shrink, eventually blocking the blood vessels. Beta rays also stop two key things from growing too much: fibroblasts (cells that make connective tissue) and new blood vessels. This is how the treatment works-with very low chances of the keloid coming back and few side effects.
For these reasons, we think combining surgery with 32P application is an effective way to treat keloids. Its success rate is similar to, or even better than, surgery combined with low-dose radiation. Also, two factors matter a lot for how well the treatment works long-term: when 32P application is started, and the dose used.
Read the detailed description
Keloids are non-cancerous (benign) growths on the skin. They form after an injury, when the skin makes too much connective tissue that thickens and hardens.
These keloids cause big problems for people. They grow uncontrollably on their own, itch, hurt, and look bad. This is especially true if they're on visible areas like the head or neck-they harm both a person's physical comfort and mental well-being.
32P application is a popular treatment for keloids. It's simple, easy to use, quick, and doesn't have many limits on where or when it can be used. Besides keloids, it also works for surface skin issues like hemangiomas.
Here's how 32P works: When it breaks down (decays), it releases beta rays. These rays create a local effect that changes the shape and function of the affected tissue. Blood vessel cells in the area swell, get inflamed, and shrink, eventually blocking the blood vessels. Beta rays also stop two key things from growing too much: fibroblasts (cells that make connective tissue) and new blood vessels. This is how the treatment works-with very low chances of the keloid coming back and few side effects.
For these reasons, we think combining surgery with 32P application is an effective way to treat keloids. Its success rate is similar to, or even better than, surgery combined with low-dose radiation. Also, two factors matter a lot for how well the treatment works long-term: when 32P application is started, and the dose used.
- Conditions
- Keloids, Keloids Scars
- Keywords
- 32P, keloids, 32P application, nuclide application therapy, nuclide therapy
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgery combined with application therapy group | Keloid lesions with a thickness greater than 3 mm are recommended to receive application therapy after surgery and have been included in this observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate: Defined as the frequency or probability of a patient experiencing a recurrence of symptoms or the condition within 2 years after being clinically deemed cured (Vancouver Scar Scale [VSS] score ≤ 5 points, with a pruritus score of 0).
Recurrence is determined by an increase in the VSS total score by ≥ 2 points compared to the clinical cure baseline. Enrolled patients will undergo sequential surgical excision followed by ³²P application therapy. The treatment endpoint is defined as either achieving a minimum therapeutic dose of 15Gy with a VSS score ≤ 5 (including a pruritus subscore of 0) or a cumulative total dose of 30Gy. After treatment completion, patients will be followed up every 6 months, and recurrence will be evaluated based on the VSS score at each follow-up visit.
Measured: From the date of achieving the treatment endpoint until 24 months post-endpoint (assessed every 6 months during follow-up).
Secondary outcomes (2)
Time to progression (TTP)
Time to progression (TTP): The time from the initiation of treatment to the occurrence of keloid progression (defined as an increase in Vancouver Scar Scale [VSS] score by ≥2 points or visible enlargement of the lesion).
Measured: Time Frame: From treatment initiation until first documented progression or study completion (whichever comes first), assessed up to 36 months
Patient satisfaction
Patient satisfaction with the final therapeutic effect will be evaluated using a validated 5-point Likert Scale, where scores are defined as follows: 1 = Extremely dissatisfied, 2 = Dissatisfied, 3 = Neutral, 4 = Satisfied, 5 = Extremely satisfied. Assessment will be conducted by trained investigators through face-to-face interviews or standardized questionnaires at the final follow-up visit.
Measured: At the final follow-up visit, which occurs 36 months after achieving the treatment endpoint (or at study completion if earlier)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeloidsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 401 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413497
- Sponsor's protocol ID
- SYSKY-2025-529-02
- Status last verified
- Aug 2025
- First submitted
- 25 Nov 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data obtained in the study
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Clinical Study on Exploring the Value of Surgical Excision Combined With 32P Application in the Treatment of Keloids and the Factors Affecting the Prognosis of Combined Therapy
- ClinicalTrials.gov ID
- NCT07413497
- Acronym / sponsor ID
- SYSKY-2025-529-02
- Conditions
- Keloids, Keloids Scars
- Keywords
- 32P, keloids, 32P application, nuclide application therapy, nuclide therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 401 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 17 Feb 2026 (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.
Keloids are non-cancerous (benign) growths on the skin. They form after an injury, when the skin makes too much connective tissue that thickens and hardens.
These keloids cause big problems for people. They grow uncontrollably on their own, itch, hurt, and look bad. This is especially true if they're on visible areas like the head or neck-they harm both a person's physical comfort and mental well-being.
32P application is a popular treatment for keloids. It's simple, easy to use, quick, and doesn't have many limits on where or when it can be used. Besides keloids, it also works for surface skin issues like hemangiomas.
Here's how 32P works: When it breaks down (decays), it releases beta rays. These rays create a local effect that changes the shape and function of the affected tissue. Blood vessel cells in the area swell, get inflamed, and shrink, eventually blocking the blood vessels. Beta rays also stop two key things from growing too much: fibroblasts (cells that make connective tissue) and new blood vessels. This is how the treatment works-with very low chances of the keloid coming back and few side effects.
For these reasons, we think combining surgery with 32P application is an effective way to treat keloids. Its success rate is similar to, or even better than, surgery combined with low-dose radiation. Also, two factors matter a lot for how well the treatment works long-term: when 32P application is started, and the dose used.
Detailed description
Keloids are non-cancerous (benign) growths on the skin. They form after an injury, when the skin makes too much connective tissue that thickens and hardens.
These keloids cause big problems for people. They grow uncontrollably on their own, itch, hurt, and look bad. This is especially true if they're on visible areas like the head or neck-they harm both a person's physical comfort and mental well-being.
32P application is a popular treatment for keloids. It's simple, easy to use, quick, and doesn't have many limits on where or when it can be used. Besides keloids, it also works for surface skin issues like hemangiomas.
Here's how 32P works: When it breaks down (decays), it releases beta rays. These rays create a local effect that changes the shape and function of the affected tissue. Blood vessel cells in the area swell, get inflamed, and shrink, eventually blocking the blood vessels. Beta rays also stop two key things from growing too much: fibroblasts (cells that make connective tissue) and new blood vessels. This is how the treatment works-with very low chances of the keloid coming back and few side effects.
For these reasons, we think combining surgery with 32P application is an effective way to treat keloids. Its success rate is similar to, or even better than, surgery combined with low-dose radiation. Also, two factors matter a lot for how well the treatment works long-term: when 32P application is started, and the dose used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery combined with application therapy group | – | –Keloid lesions with a thickness greater than 3 mm are recommended to receive application therapy after surgery and have been included in this observational study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will be conducted in patients diagnosed with keloids who meet the surgical indications. Investigators or designated personnel must ensure that only patients who meet all the following inclusion criteria and have no exclusion criteria are enrolled in the study.
Key inclusion criteria (6 listed)
- Histological biopsy confirms the patient has keloids. Pathological diagnostic criteria include: 1. Proliferating fibroblasts: A large number of proliferating fibroblasts are usually detected in keloid tissue. 2. Disordered arrangement of collagen fibers: Collagen fibers in normal scars are generally arranged in an orderly manner, while in keloids, they are disorganized and present as thick bundles. 3. Scar tissue extending beyond the original wound boundaries: Keloid tissue often spreads beyond the scope of the initial trauma.
- Patients with keloids ≥3 mm in thickness and within 1 week after surgical excision.
- Patients have at least one measurable lesion as defined by the Vancouver Scar Scale (VSS) criteria.
- Patients have no other skin disorders similar to keloids.
- Patients are capable of understanding and signing the informed consent form.
Key exclusion criteria (7 listed)
- Difficulty in accurately assessing the patient's lesions.
- Patients who do not meet the indications for local excision or have received superficial radiotherapy after surgery.
- Dementia, intellectual impairment, or any mental illness that hinders the understanding of the informed consent form.
- Patients deemed inappropriate to participate in this clinical study by the investigator.
- Patients from whom pathological specimens cannot be obtained, or those who die or are lost to 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
Recurrence rate: Defined as the frequency or probability of a patient experiencing a recurrence of symptoms or the condition within 2 years after being clinically deemed cured (Vancouver Scar Scale [VSS] score ≤ 5 points, with a pruritus score of 0).
Time frame: From the date of achieving the treatment endpoint until 24 months post-endpoint (assessed every 6 months during follow-up).
Recurrence is determined by an increase in the VSS total score by ≥ 2 points compared to the clinical cure baseline. Enrolled patients will undergo sequential surgical excision followed by ³²P application therapy. The treatment endpoint is defined as either achieving a minimum therapeutic dose of 15Gy with a VSS score ≤ 5 (including a pruritus subscore of 0) or a cumulative total dose of 30Gy. After treatment completion, patients will be followed up every 6 months, and recurrence will be evaluated based on the VSS score at each follow-up visit.
2 secondary outcomes
Time to progression (TTP)
Time frame: Time Frame: From treatment initiation until first documented progression or study completion (whichever comes first), assessed up to 36 months
Patient satisfaction
Time frame: At the final follow-up visit, which occurs 36 months after achieving the treatment endpoint (or at study completion if earlier)
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 17 Feb 2026.
- Individual participant dataSharing planned: Yes. All data obtained in the study
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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.
Jiachen Liu contact
Questions about this trial
What is this clinical trial studying?
An observational study of Keloids and Keloids Scars, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Dan Li, Principal Investigator（PI） (+8613918963005, lidan269@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate: Defined as the frequency or probability of a patient experiencing a recurrence of symptoms or the condition within 2 years after being clinically deemed cured (Vancouver Scar Scale [VSS] score ≤ 5 points, with a pruritus score of 0). (time frame: From the date of achieving the treatment endpoint until 24 months post-endpoint (assessed every 6 months during follow-up).). 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 17 Feb 2026.