Keloid
Conditions
Interventions
Test group:Dual-Wavelength Dye Laser Combined with Betamathasone Injection
Control group:Betamathasone Injection
Sponsors
Department of Plastic Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Males or females aged 18 years or older (including 18 years); 2) Participants diagnosed with keloids by researchers, which can be improved through intralesional injections and dual-wavelength dye laser treatment; 3) Keloids with a maximum diameter greater than 0.5cm but less than 5cm, and a duration of more than 6 months; 4) Fitzpatrick skin type II-IV; 5) Participants desiring improvement in the appearance of their keloid scars; 6) Participants voluntarily signing an informed consent form and agreeing to complete the follow-up as per the trial protocol.
Exclusion criteria
Exclusion criteria: 1) Participants with active infection in keloids (such as itching, pain, ulceration, suppuration), or unhealed wounds, or skin diseases in the progressive phase such as vitiligo, psoriasis, etc.; 2) Those who received or plan to receive treatments or surgeries that could affect the trial within three months before screening, such as betamathasone, 5-fluorouracil, verapamil, botulinum toxin, dual-wavelength dye laser, carbon dioxide laser, ablative fractional laser, radiation therapy; 3) Participants with a history of severe allergies diseases, hereditary allergies, those planning desensitization treatment during the study, or allergic to components of the trial treatments or devices; 4) Participants with a history of coagulation disorders, or those who used or planned to use anticoagulant, antiplatelet, or thrombolytic treatment (such as warfarin, aspirin) within 14 days before screening; 5) Pregnant or nursing women, those planning pregnancy during the trial (or males unwilling to use appropriate contraception), or those with positive pregnancy test results during screening; 6) Participants with a history of severe organ diseases or active autoimmune diseases; 7) Participants who have participated in other clinical trials within 30 days before screening; 8) Participants deemed unsuitable for the trial by researchers due to other systemic diseases or abnormal laboratory test results; 9) Participants unable to communicate or follow instructions; 10) Other conditions deemed inappropriate for participation in the trial by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The improvement rate base on vancounver scar scale(VSS); | — |
Secondary
| Measure | Time frame |
|---|---|
| The improvement rate base on VSS;The improvement rate base on VSS;Perfusion index of keloids;The socre patient and observer scar assessmentscale(POSAS);Patient Satisfaction; | — |
Countries
China
Contacts
Public ContactNanze Yu, Wang Xiaojun
Department of Plastic Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed