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

Early Phase 1
Recruiting
Conditions
keloid
Registration Number
ITMCTR2024000046
Lead Sponsor
Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(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.

Exclusion Criteria

(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.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The Vancouver Scar Scale.;
Secondary Outcome Measures
NameTimeMethod
keloid pain VAS;Ultrasound of the body surface at the keloid;Doctor satisfaction;Patient satisfaction;keloid itching VAS;volume of keloid;
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