Sound waves and herbs take on 'Non-Killing Cancer' of keloid scars
NCT ID NCT07679243
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests a new approach for treating keloids—thick, raised scars that can be painful and itchy. The treatment combines wide-band ultrasound with a traditional Chinese medicine preparation applied to the skin. The goal is to soften scar tissue, reduce symptoms, and prevent recurrence after surgery, without the side effects of radiation or steroid injections. The trial involves 120 people with multiple keloids and compares the combination therapy to standard care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- wide-band ultrasound and traditional Chinese medicine preparation (Chuang Li Fu)
- What this could lead to
- If it works, this could offer a non-invasive, low-risk treatment for keloids that reduces pain, itching, and scar size without surgery or radiation.
- What could go wrong
- This is an early-phase trial with only 120 participants, so results may not apply to everyone. The treatment may not work as well as standard therapies, and long-term effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
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.
- Ages
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14 to 60 years
- 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: 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.
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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
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an asthma drug tame stubborn keloid scars?
- Do future doctors know the skin risks of tattoos and piercings?
- New PET scan tracer could spot keloids without a biopsy
- Can a simple ointment before surgery lead to better scars?
- Plasma zaps scars: new device aims to smooth skin
- 7,000 volunteers needed to crack the genetic code of keloids.