KeloidPhase 1/2WBUS +TCMNCT07679243
A Clinical Study on the Safety and Efficacy of Wide-Band Ultrasound Combined With Traditional Chinese Medicine Preparations in the Prevention and Treatment of Keloids
A Phase 1/2 study testing Wide-Band Ultrasound and traditional Chinese medicine in people with Keloid, run by Fujian Medical University Union Hospital.
Trial summary
The prevention and treatment of patients with multiple keloids throughout the body are extremely challenging. Keloids are highly resistant, refractory, and prone to recurrence, and are thus known as the "cancer that does not kill". Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Keloid
- What is being tested?
- Wide-Band Ultrasound and traditional Chinese medicine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Oct 2028
- Phase
- Phase 1/2
- 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- I-1 Multiple keloid lesions (≥2) on the body, requiring surgical excision and revision. The two targeted lesions shall be separated by at least 1 cm and located in the same anatomical region (e.g., abdomen, chest, upper extremity, lower leg, etc.).
- I-2 Aged 14 to 60 years. I-3 The targeted keloid lesions have shown no significant spontaneous regression or continuous enlargement within the past 3-6 months,or are accompanied by obvious symptoms such as itching or pain.
- I-4 Has fully understood the purpose, protocol, potential benefits, risks, countermeasures, and rights and obligations of the study (including privacy protection and voluntary withdrawal), and is willing to participate and cooperate well.
- I-5 Able to understand and sign the informed consent form, and willing to comply with treatment and follow-up.
- I-6 No history of allergy to any known components of the selected traditional Chinese medicine (TCM) preparation.
- I-7 No prior treatment for the targeted keloid lesions within 6 months before study initiation.
Who cannot join
- E-1 Currently participating in other clinical trials.E-2 Active infection or ulceration present in the targeted keloid area.E-3 Refusal to undergo surgery or biopsy for pathological confirmation.E-4 Hypertension, hypotension, or heart disease (including history of myocardial ischemia, coronary heart disease, myocarditis, etc.).E-5 Hepatic or renal insufficiency.E-6 Infectious diseases (including viral hepatitis, syphilis, AIDS, etc.).E-7 Hematological disorders (abnormal coagulation function, anemia, leukemia, polycythemia vera, aplastic anemia, etc.).E-8 Allergic constitution (urticaria, bronchial asthma, history of allergy to more than two drugs or foods).E-9 Respiratory diseases (chronic bronchitis, emphysema, bronchiectasis, pulmonary insufficiency, chronic obstructive pulmonary disease, interstitial pneumonia).E-10 Digestive system diseases (severe gastric and duodenal ulcers, chronic gastroenteritis, chronic pancreatitis).E-11 Urinary system diseases (chronic urinary tract infection, nephritis, nephrotic syndrome).E-12 Endocrine system diseases (hyperthyroidism, diabetes, acromegaly, pituitary diseases, adrenal diseases, etc.).E-13 Organic neurological diseases or mental illnesses (encephalitis, sequelae of brain trauma, epilepsy, schizophrenia, hysteria, depression, severe insomnia, neurasthenia).E-14 Chronic skin diseases (especially infectious, allergic and inflammatory systemic skin diseases, such as generalized eczema, psoriasis, pemphigus, etc.).E-15 Autoimmune diseases and collagen diseases (such as SLE, dermatomyositis, scleroderma, etc.).E-16 History of long-term smoking, alcohol abuse, or drug abuse.E-17 History of malignant tumor within the past 5 years, currently requiring other treatments such as radiotherapy and chemotherapy.E-18 Received blood transfusion or organ transplantation from others within the past 5 years.E-19 Pregnant, lactating, menstruating, or within 1 year after termination of pregnancy.E-20 Other conditions deemed unsuitable for participation in the study by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The prevention and treatment of patients with multiple keloids throughout the body are extremely challenging. Keloids are highly resistant, refractory, and prone to recurrence, and are thus known as the "cancer that does not kill". At present, the main clinical strategy for such patients is staged surgical resection, followed by adjuvant local radiotherapy. When signs of recurrence appear, local injection of triamcinolone acetonide plus 5-fluorouracil (5-Fu) is administered as supplementary treatment. However, these two combination therapies have obvious limitations.
Adjuvant postoperative radiotherapy is associated with a high incidence of local skin adverse reactions, including radiodermatitis and delayed wound healing. Late complications may occur weeks or months after treatment, such as permanent hyperpigmentation and hypopigmentation, skin atrophy, fibrosis, scabbing and desquamation, and intractable ulcers. In addition, radiotherapy is not suitable for some young female patients and children when keloids are located near organs such as the thyroid gland and gonads.
Read more
Injection of triamcinolone acetonide plus 5-Fu causes significant pain and requires repeated sessions. Potential risks include local ulceration, hyperpigmentation, telangiectasia, and menstrual irregularities in female patients. Therefore, there is an urgent clinical need for a pathological scar prevention and treatment technique that can rapidly relieve discomfort, promote scar atrophy, cause no secondary injury, carry low risks, have a short recovery period, provide high comfort during treatment, and be applicable to large-area or multiple pathological scars across the body.
Our research team previously observed in clinical practice that wide-band ultrasound (Universal Beauty® Type I Ultrasound Therapeutic Device) combined with traditional Chinese medicine (TCM) preparations can release abnormally accumulated and contracted collagen fibers in scar tissue via ultrasonic energy. Meanwhile, ultrasound promotes the penetration of TCM into scar lesions, exerting effects of infection control, inflammation inhibition, subsidence of redness and swelling, and relief of itching and pain.
Compared with conventional scar therapies, this approach achieves rapid symptom control, no secondary damage, no obvious side effects, a short recovery period, and high treatment comfort. It shows particularly significant advantages for large-area or multiple pathological scars throughout the body that are difficult to treat with traditional methods. Preliminary treatment in a small number of volunteers with multiple keloids has achieved satisfactory outcomes without obvious adverse reactions.
The purpose of this study is to verify the efficacy and safety of wide-band ultrasound combined with TCM preparation (Chuang Li Fu) in the prevention and treatment of keloids through this clinical trial.
Read the detailed description
In this study design, surgically excised keloids were randomly assigned to 4 groups:
Blank control group (Group 0#) Ultrasound + TCM preparation group (Group 1#) Ultrasound + normal saline group (Group 2#) TCM gauze external application alone group (Group 3#) All treatments were administered once every 3 days, for a total of 10 sessions.After treatment, all keloid tissues were surgically removed and subjected to pathological examination to evaluate efficacy.
At 1 week after suture removal, all incisions received intervention with wide-band ultrasound combined with TCM preparations.Treatment was performed once every other week, for a total of 12 sessions.Subsequently, follow-up was conducted once monthly until 12 months after the last intervention.
- Conditions
- Keloid
- Being tested
- Wide-Band Ultrasound, traditional Chinese medicine
- Keywords
- keloid, Wide-Band Ultrasound, Traditional Chinese Medicine
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wide-Band UltrasoundDevice
The ultrasound probe is placed over the gauze during treatment.
traditional Chinese medicineDrug
Gauze saturated with TCM preparation is applied onto the keloid lesion
| Study group | Role | What they receive |
|---|---|---|
| Blank control group (Group 0#) | No intervention | No Intervention |
| Ultrasound + TCM preparation group (Group 1#) | Experimental | The gauze saturated with the traditional Chinese medicine (TCM) preparation was applied to the keloid lesion, followed by treatment with a wide-band ultrasound therapeutic probe placed over the gauze. Receives: Device: Wide-Band Ultrasound; Drug: traditional Chinese medicine |
| Ultrasound + normal saline group (Group 2#) | Experimental | A gauze saturated with normal saline is applied to the keloid lesion, and a wide-band ultrasound therapeutic probe is then placed over the gauze to perform treatment. Receives: Device: Wide-Band Ultrasound |
| TCM gauze external application alone group (Group 3#) | Experimental | Only gauze saturated with the traditional Chinese medicine (TCM) preparation was applied to the keloid lesion for 30 minutes (the gauze was covered with plastic wrap to enhance penetration and immersion). Receives: Drug: traditional Chinese medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vancouver Scar Scale (VSS)
① After the first stage: the improvement in the experimental group was at least 2 points greater than that in the control group, with statistical significance.② At follow-up endpoint: no obvious hypertrophic growth in any incision scar.
Measured: up to 3 months
Patient and Observer Scar Assessment Scale (POSAS)
① At the end of Stage 1: The improvement in the experimental group was at least 6 points greater than that in the control group, with statistical significance. In addition, the three sub-items (vascularity, itching, pain) each improved by at least 2 points, with statistical significance.
② At follow-up endpoint: No obvious hypertrophic proliferation was observed in any incision scar.
Measured: up to 3 months
Scar height above the surrounding skin
① At the end of Stage 1: The scar height in the experimental group was lower than that in the control group, with statistical significance.② At follow-up endpoint: No obvious hypertrophic proliferation was observed in any incision scar.
Measured: up to 3 months
Number and proportion of scar recurrence and hypertrophy
At follow-up endpoint, incisional recurrence rate will be lower than the 20% minimum recurrence rate of postoperative radiotherapy reported in literature.
Measured: through study completion , an average 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeloidStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679243
- Sponsor's protocol ID
- 2025KY744-01
- Acronym
- WBUS +TCM
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data (IPD) will not be shared because the study does not plan to provide access to raw individual participant data to external researchers, in order to protect participant privacy, maintain data confidentiality, and comply with ethical and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety and Efficacy of Wide-Band Ultrasound Combined With Traditional Chinese Medicine Preparations in the Prevention and Treatment of Keloids
- ClinicalTrials.gov ID
- NCT07679243
- Acronym / sponsor ID
- WBUS +TCM / 2025KY744-01
- Conditions
- Keloid
- Keywords
- keloid, Wide-Band Ultrasound, Traditional Chinese Medicine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 1 Jul 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.
The prevention and treatment of patients with multiple keloids throughout the body are extremely challenging. Keloids are highly resistant, refractory, and prone to recurrence, and are thus known as the "cancer that does not kill". At present, the main clinical strategy for such patients is staged surgical resection, followed by adjuvant local radiotherapy. When signs of recurrence appear, local injection of triamcinolone acetonide plus 5-fluorouracil (5-Fu) is administered as supplementary treatment. However, these two combination therapies have obvious limitations.
Adjuvant postoperative radiotherapy is associated with a high incidence of local skin adverse reactions, including radiodermatitis and delayed wound healing. Late complications may occur weeks or months after treatment, such as permanent hyperpigmentation and hypopigmentation, skin atrophy, fibrosis, scabbing and desquamation, and intractable ulcers. In addition, radiotherapy is not suitable for some young female patients and children when keloids are located near organs such as the thyroid gland and gonads.
Injection of triamcinolone acetonide plus 5-Fu causes significant pain and requires repeated sessions. Potential risks include local ulceration, hyperpigmentation, telangiectasia, and menstrual irregularities in female patients. Therefore, there is an urgent clinical need for a pathological scar prevention and treatment technique that can rapidly relieve discomfort, promote scar atrophy, cause no secondary injury, carry low risks, have a short recovery period, provide high comfort during treatment, and be applicable to large-area or multiple pathological scars across the body.
Our research team previously observed in clinical practice that wide-band ultrasound (Universal Beauty® Type I Ultrasound Therapeutic Device) combined with traditional Chinese medicine (TCM) preparations can release abnormally accumulated and contracted collagen fibers in scar tissue via ultrasonic energy. Meanwhile, ultrasound promotes the penetration of TCM into scar lesions, exerting effects of infection control, inflammation inhibition, subsidence of redness and swelling, and relief of itching and pain.
Compared with conventional scar therapies, this approach achieves rapid symptom control, no secondary damage, no obvious side effects, a short recovery period, and high treatment comfort. It shows particularly significant advantages for large-area or multiple pathological scars throughout the body that are difficult to treat with traditional methods. Preliminary treatment in a small number of volunteers with multiple keloids has achieved satisfactory outcomes without obvious adverse reactions.
The purpose of this study is to verify the efficacy and safety of wide-band ultrasound combined with TCM preparation (Chuang Li Fu) in the prevention and treatment of keloids through this clinical trial.
Detailed description
In this study design, surgically excised keloids were randomly assigned to 4 groups:
Blank control group (Group 0#) Ultrasound + TCM preparation group (Group 1#) Ultrasound + normal saline group (Group 2#) TCM gauze external application alone group (Group 3#) All treatments were administered once every 3 days, for a total of 10 sessions.After treatment, all keloid tissues were surgically removed and subjected to pathological examination to evaluate efficacy.
At 1 week after suture removal, all incisions received intervention with wide-band ultrasound combined with TCM preparations.Treatment was performed once every other week, for a total of 12 sessions.Subsequently, follow-up was conducted once monthly until 12 months after the last intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Blank control group (Group 0#) | No intervention | –No Intervention |
| Ultrasound + TCM preparation group (Group 1#) | Experimental | Device: Wide-Band Ultrasound, Drug: traditional Chinese medicineThe gauze saturated with the traditional Chinese medicine (TCM) preparation was applied to the keloid lesion, followed by treatment with a wide-band ultrasound therapeutic probe placed over the gauze. |
| Ultrasound + normal saline group (Group 2#) | Experimental | Device: Wide-Band UltrasoundA gauze saturated with normal saline is applied to the keloid lesion, and a wide-band ultrasound therapeutic probe is then placed over the gauze to perform treatment. |
| TCM gauze external application alone group (Group 3#) | Experimental | Drug: traditional Chinese medicineOnly gauze saturated with the traditional Chinese medicine (TCM) preparation was applied to the keloid lesion for 30 minutes (the gauze was covered with plastic wrap to enhance penetration and immersion). |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- I-1 Multiple keloid lesions (≥2) on the body, requiring surgical excision and revision. The two targeted lesions shall be separated by at least 1 cm and located in the same anatomical region (e.g., abdomen, chest, upper extremity, lower leg, etc.).
- I-2 Aged 14 to 60 years. I-3 The targeted keloid lesions have shown no significant spontaneous regression or continuous enlargement within the past 3-6 months,or are accompanied by obvious symptoms such as itching or pain.
- I-4 Has fully understood the purpose, protocol, potential benefits, risks, countermeasures, and rights and obligations of the study (including privacy protection and voluntary withdrawal), and is willing to participate and cooperate well.
- I-5 Able to understand and sign the informed consent form, and willing to comply with treatment and follow-up.
- I-6 No history of allergy to any known components of the selected traditional Chinese medicine (TCM) preparation.
Key exclusion criteria (1 listed)
- E-1 Currently participating in other clinical trials.E-2 Active infection or ulceration present in the targeted keloid area.E-3 Refusal to undergo surgery or biopsy for pathological confirmation.E-4 Hypertension, hypotension, or heart disease (including history of myocardial ischemia, coronary heart disease, myocarditis, etc.).E-5 Hepatic or renal insufficiency.E-6 Infectious diseases (including viral hepatitis, syphilis, AIDS, etc.).E-7 Hematological disorders (abnormal coagulation function, anemia, leukemia, polycythemia vera, aplastic anemia, etc.).E-8 Allergic constitution (urticaria, bronchial asthma, history of allergy to more than two drugs or foods).E-9 Respiratory diseases (chronic bronchitis, emphysema, bronchiectasis, pulmonary insufficiency, chronic obstructive pulmonary disease, interstitial pneumonia).E-10 Digestive system diseases (severe gastric and duodenal ulcers, chronic gastroenteritis, chronic pancreatitis).E-11 Urinary system diseases (chronic urinary tract infection, nephritis, nephrotic syndrome).E-12 Endocrine system diseases (hyperthyroidism, diabetes, acromegaly, pituitary diseases, adrenal diseases, etc.).E-13 Organic neurological diseases or mental illnesses (encephalitis, sequelae of brain trauma, epilepsy, schizophrenia, hysteria, depression, severe insomnia, neurasthenia).E-14 Chronic skin diseases (especially infectious, allergic and inflammatory systemic skin diseases, such as generalized eczema, psoriasis, pemphigus, etc.).E-15 Autoimmune diseases and collagen diseases (such as SLE, dermatomyositis, scleroderma, etc.).E-16 History of long-term smoking, alcohol abuse, or drug abuse.E-17 History of malignant tumor within the past 5 years, currently requiring other treatments such as radiotherapy and chemotherapy.E-18 Received blood transfusion or organ transplantation from others within the past 5 years.E-19 Pregnant, lactating, menstruating, or within 1 year after termination of pregnancy.E-20 Other conditions deemed unsuitable for participation in the study by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wide-Band UltrasoundThe ultrasound probe is placed over the gauze during treatment. | Device | Ultrasound + TCM preparation group (Group 1#), Ultrasound + normal saline group (Group 2#) |
| traditional Chinese medicineGauze saturated with TCM preparation is applied onto the keloid lesion | Drug | TCM gauze external application alone group (Group 3#), Ultrasound + TCM preparation group (Group 1#) |
Primary outcome
Vancouver Scar Scale (VSS)
Time frame: up to 3 months
① After the first stage: the improvement in the experimental group was at least 2 points greater than that in the control group, with statistical significance.② At follow-up endpoint: no obvious hypertrophic growth in any incision scar.
Patient and Observer Scar Assessment Scale (POSAS)
Time frame: up to 3 months
① At the end of Stage 1: The improvement in the experimental group was at least 6 points greater than that in the control group, with statistical significance. In addition, the three sub-items (vascularity, itching, pain) each improved by at least 2 points, with statistical significance. ② At follow-up endpoint: No obvious hypertrophic proliferation was observed in any incision scar.
Scar height above the surrounding skin
Time frame: up to 3 months
① At the end of Stage 1: The scar height in the experimental group was lower than that in the control group, with statistical significance.② At follow-up endpoint: No obvious hypertrophic proliferation was observed in any incision scar.
Number and proportion of scar recurrence and hypertrophy
Time frame: through study completion , an average 1.5 year
At follow-up endpoint, incisional recurrence rate will be lower than the 20% minimum recurrence rate of postoperative radiotherapy reported in literature.
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 1 Jul 2026.
- Individual participant dataSharing planned: No. Individual patient data (IPD) will not be shared because the study does not plan to provide access to raw individual participant data to external researchers, in order to protect participant privacy, maintain data confidentiality, and comply with ethical and institutional policies.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Wide-Band Ultrasound and traditional Chinese medicine in people with Keloid, run by Fujian Medical University Union Hospital.
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 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: opening soon, as of the sponsor's last update on 1 Jul 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Li Ming Li, Doctor of Philosophy (+86 18259061605, fmulm@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vancouver Scar Scale (VSS) (time frame: up to 3 months). The study lists 4 primary outcomes in all. 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 1 Jul 2026.