An observational study in Keloids and Keloids Scars, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Observational
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.
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.
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's planned enrollment of 401 is above the median of 100 across 23 observational studies indexed under Keloid.
Browse Keloid studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 483 studies on the registry; 283 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: From the date of achieving the treatment endpoint until 24 months post-endpoint (assessed every 6 months during follow-up).
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).
Time frame: 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.
Time frame: At the final follow-up visit, which occurs 36 months after achieving the treatment endpoint (or at study completion if earlier)
No study locations are listed for this record.
Plan to share: Yes — All data obtained in the study
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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