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

Overview

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.

Interventions

• Device Wide-Band Ultrasound
  The ultrasound probe is placed over the gauze during treatment.
• Drug traditional Chinese medicine
  Gauze saturated with TCM preparation is applied onto the keloid lesion

Primary outcome measures

• Vancouver Scar Scale (VSS) [Time frame: up to 3 months]
• Patient and Observer Scar Assessment Scale (POSAS) [Time frame: up to 3 months]
• Scar height above the surrounding skin [Time frame: up to 3 months]
• Number and proportion of scar recurrence and hypertrophy [Time frame: through study completion , an average 1.5 year]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07679243 · 2025KY744-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗