New combo therapy aims to tame unruly scars
NCT ID NCT07413497
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether removing keloids surgically and then applying a radioactive patch (32P) can prevent them from returning. About 401 people with keloids will get this treatment and be checked every 6 months for 2 years. The goal is to see how well the combo works and what factors affect success.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 401 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 2. Patients with keloids ≥3 mm in thickness and within 1 week after surgical excision. 3. Patients have at least one measurable lesion as defined by the Vancouver Scar Scale (VSS) criteria. 4. Patients have no other skin disorders similar to keloids. 5. Patients are capable of understanding and signing the informed consent form. 6. Patients are willing and able to comply with scheduled visits, treatment plans, laboratory tests, follow-up appointments, and other study procedures. Exclusion Criteria: 1. Difficulty in accurately assessing the patient's lesions. 2. Patients who do not meet the indications for local excision or have received superficial radiotherapy after surgery. 3. Dementia, intellectual impairment, or any mental illness that hinders the understanding of the informed consent form. 4. Patients deemed inappropriate to participate in this clinical study by the investigator. 5. Patients from whom pathological specimens cannot be obtained, or those who die or are lost to follow-up. 6. Patients with recurrent keloids following previous treatment. 7. Pregnant female patients. -
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
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A doctor treating you
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