Juvenile Localized Sclderma
Conditions
Interventions
drug treatment group:methotrexate + basic treatment
autologous fat transplantation group:autologous fat transplantation + basic treatment
observation group (control group):basic treatment
Sponsors
Shanghai Ninth People's Hosptial,Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed as localized scleroderma by rheumatology evaluation: according to clinical manifestations (usually chronic persistent disease, erythema/rash on the skin at the lesion site, gradual thickening, sclerosis, atrophy/sag, clear boundary, may be associated with Pigmentation or depigmentation), combined with skin and subcutaneous tissue biopsy for diagnosis, and eosinophilic fasciitis, lichen sclerosus, systemic sclerosis, etc. should be excluded at the same time; 2. Aged <18 years old, male or female; 3. The legal guardian of the subject is fully aware of and signed the informed consent, and the subject can cooperate to complete the follow-up.
Exclusion criteria
Exclusion criteria: 1. The type of localized morphea in localized scleroderma; 2. Involving internal organs or accompanied by other serious complications; 3. BMI is less than P5th of the same sex and age (Appendix 1), or the thickness of subcutaneous fat is less than 1cm, or the volume of subcutaneous fat that can be aspirated before surgery is judged by the investigator to be insufficient to restore the amount of soft tissue in the lesion area; 4. Those who are participating in other clinical trial projects, or the other clinical trial projects have been out for less than 6 months; 5. Are receiving anticoagulation (eg, warfarin), non-steroidal anti-inflammatory drugs (NSAIDs) ( For example, aspirin, ibuprofen) or other substances known to prolong clotting time (eg, ginkgo biloba herbal supplements); 6. Subjects with a history of bleeding disorders; 7. Those with severe cardiovascular, liver or kidney disease; 8. Have any known malignant tumor, or a history of malignant tumor of any organ system within the past 5 years; 9. Subjects who plan to perform any surgery unrelated to this trial during the clinical research period and may have an impact on the results of this trial or take other drugs that may affect the judgment of the results of this trial; 10. Other treatment contraindications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of clinical improvement with drugs and autologous fat transplantation at 24 weeks of treatment; | — |
Countries
China
Contacts
Public ContactXie Yun
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed