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

NCT07679243 | Not Yet Recruiting Phase 1

• 1 other identifier: 2025KY744-01
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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". 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.

Conditions

Keloid

Keywords

keloid; Wide-Band Ultrasound; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  through study completion , an average 1.5 year

Study Arms (4)

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.

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.

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).

Drug: traditional Chinese medicine

Interventions

Wide-Band Ultrasound DEVICE

The ultrasound probe is placed over the gauze during treatment.

Ultrasound + TCM preparation group (Group 1#); Ultrasound + normal saline group (Group 2#)

traditional Chinese medicine DRUG

Gauze saturated with TCM preparation is applied onto the keloid lesion

TCM gauze external application alone group (Group 3#); Ultrasound + TCM preparation group (Group 1#)

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

MeSH Terms

Conditions

Keloid

Interventions

Medicine, Chinese Traditional

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics

Central Study Contacts

Li Ming Li, Doctor of Philosophy

CONTACT

+86 18259061605; fmulm@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: July 1, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: July 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share