A Prospective Observational Clinical Study on Exploring t... | NCT07413497

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2026Estimated

Primary Completion Date

Jun 1, 2029Estimated

Completion Date

Jun 1, 2030Estimated

First Submitted Date

Nov 25, 2025

First Submission Date that Met QC Criteria

Feb 9, 2026

First Posted Date

Feb 17, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2026

Last Update Posted Date

Feb 17, 2026Actual

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

401Estimated

Label	Type	Description	Intervention Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	From the date of achieving the treatment endpoint until 24 months post-endpoint (assessed every 6 months during follow-up).

Secondary Outcomes

Measure	Description	Time Frame
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: From treatment initiation until first documented progression or study completion (whichever comes first), assessed up to 36 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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. -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Dan Li, Principal Investigator（PI）	Contact	+8613918963005		lidan269@mail.sysu.edu.cn
Jiachen Liu	Contact	+8615820288637

ID	Term
D003095	Collagen Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D002921	Cicatrix
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms