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Clinical Randomized Controlled Trial of Fire Needle Combined with Black Cloth Ointment in the Treatment of Keloid

Clinical Randomized Controlled Trial of Fire Needle Combined with Black Cloth Ointment in the Treatment of Keloid

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084586
Enrollment
Unknown
Registered
2024-05-21
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

keloid

Interventions

Sponsors

Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: keloid: (1) meet the diagnostic criteria of keloid; (2) Scar skin lesions 1 cm = length = 15 cm and 0.5 cm = width = 8 cm and thickness = 8 mm; (3) Scar formation time > 1 year; (4) The number of scars = 5; (5) Non-hand and foot and non-scar near mucosa; (6) Age between 18 and 65 years old, regardless of gender; (7) No serious uncontrollable systemic diseases; (8) Signing informed consent. At the same time meet all the above criteria to be included. Healthy subjects: (1) People without scars all over the body; (2) Patients with benign skin tumor resection in the dermatology clinic of Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University; (3) Age between 18 and 65 years old, regardless of gender; (4) Patients without inflammatory skin diseases; (5) Those who sign the informed consent form. At the same time meet all the above criteria to be included.

Exclusion criteria

Exclusion criteria: keloid: (1) There are obvious primary or secondary infections in the skin around the scar; (2) Allergic to therapeutic drugs; (3) Women preparing for pregnancy and pregnancy; (4) Patients who are participating in other clinical trials; (5) Allergy to lidocaine; (6) Those who had been treated for keloids within one month before inclusion. Those who meet any of the above items cannot be selected. Healthy subjects: (1) Patients with scar constitution; (2) Patients with previous systemic diseases (such as hypertension, diabetes, malignant tumors, etc.) (3) Those aged 65 years old. Those who meet any of the above items cannot be selected.

Design outcomes

Primary

MeasureTime frame
The Vancouver Scar Scale.;

Secondary

MeasureTime frame
keloid pain VAS;keloid itching VAS;Ultrasound of the body surface at the keloid;volume of keloid;Patient satisfaction;Doctor satisfaction;

Countries

china

Contacts

Public ContactWeiwen Chen

Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University

chenweiwen@bjzhongyi.com+86 185 1986 6309

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026