previous?Vitiligo
Conditions
Interventions
Psoriasis observation group:Subcutaneous injection of IL-17A inhibitor
Vitiligo observation group:Oral glucocorticoid micro pulse therapy
Sponsors
People’s Hospital of Xinjiang Uygur Autonomous Region
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Psoriasis: 1. Male or female subjects aged 6-80 (inclusive) [subject to the date of signing the informed consent form (ICF)]; 2. Body weight = 50 kg, BMI value above 28 kg/m2; 3. Subjects with moderate or severe plaque psoriasis at baseline were defined as follows: BSA = 10%, PASI = 12 and sPGA score = 3; 4. Meet the diagnostic indicators of metabolic syndrome: (1) Waist circumference of women>80cm, or waist hip ratio>0.8. The waist circumference of men is>90cm, or the waist hip ratio is>0.9. (2) Triacylglycerol > 4.8 mmol/L. (3) HDL cholesterol 130/85mmHg. (5) Fasting blood glucose 6.1~6.9 nmol/L. (6) 2h OGTT (75g glucose) 7.8 11.1 nmol/L. Obesity is a necessary indicator in the above criteria, and 3 of the remaining 5 items can be diagnosed. 5. If a woman of childbearing age is not pregnant or lactating, the subjects and their partners should voluntarily take contraceptive measures that the researchers consider effective during the treatment period and at least 6 months after receiving the study drug for the last time; 6. The subject must be able to communicate well with the researcher and comply with the requirements of the study, and sign a written informed consent. 7. Subjects must be willing and able to complete the study procedure and follow-up examination. Vitiligo: 1. The subject must be able to communicate well with the researcher and comply with the requirements of the study, and sign a written informed consent; 2. Age = 18 years; 3. Have not received systemic glucocorticoid treatment before; 4. Refer to vitiligo disease activity score (VIDA), clinical characteristics, isomorphic reaction, and Wood lamp examination results for judgment of progress period. ? VIDA points: according to the time when new lesions or original lesions were expanded,+4 points appeared in the last 6 weeks,+3 points appeared in the last 3 months,+2 points appeared in the last 6 months,+1 point appeared in the last year, 0 point was obtained if it was stable for at least 1 year, and - 1 point was obtained if it was stable for at least 1 year and had spontaneous pigment regeneration; If the total score is>1, it is a period of progress; if the total score is = 4, it is a period of rapid progress; ? Clinical features: the skin lesions with blurry edges, inflammatory vitiligo (including pruritus, erythema, etc.), trichrome vitiligo, scraps like white spots or hypopigmentation spots and other clinical manifestations can be determined as progressive vitiligo; ? Homomorphic reaction: white spots appear at the damaged part of the skin within one year, and the damage mode can be physical (trauma, cutting, scratch, mechanical friction, lasting compression, heat burn, freezing injury), chemical, allergic (allergic contact dermatitis) or other inflammatory skin diseases, irritant reactions (vaccination, tattoo, etc.), therapeutic (radiotherapy, phototherapy), etc; ? Wood lamp examination results: the skin lesions were grayish white in color, and the boundary was not clear. The area of skin lesions under the wood lamp was larger than the visual area, indicating that it was in progress. If any one of the above four conditions is met, the disease progression can be considered.
Exclusion criteria
Exclusion criteria: Psoriasis: 1. At screening or baseline, patients with psoriasis other than chronic plaque type (such as pustular type, erythrodermic type and guttate psoriasis); 2. Drug induced psoriasis at baseline (i.e ß New psoriasis or aggravation of psoriasis caused by blockers, calcium channel inhibitors or lithium); 3. Other active skin diseases or skin infections (bacteria, fungi or viruses) that may affect the clinical evaluation of psoriasis; 4. Biological agents are not applicable; 5. Evidence of alcohol or drug abuse history or ongoing abuse within six months before baseline; 6. Mental disorders or visual and hearing disorders and other factors that hinder the normal progress of the questionnaire survey; 7. Refused to participate in the informed consent process or failed to cooperate to complete the blood and stool collection. Vitiligo: 1. Patients with contraindication of systemic hormone use; 2. Mental disorders or visual and hearing disorders and other factors that hinder the normal progress of the questionnaire survey; 3. Refusing to participate in the informed consent process or failing to cooperate to complete the blood and stool collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| psoriasis area and severity index,PASI;BSA;physician's global assessment,PGA;vitiligo area scoring index,VASI;vitiligo disease activity,VIDA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic indicators of metabolic syndrome;international physical activity questionnaire,IPAQ;patient health questionnaire-9,PGQ-9;generalized anxiety disorder-7,GAD-7; | — |
Countries
China
Contacts
Public ContactXiaojing Kang
People’s Hospital of Xinjiang Uygur Autonomous Region
Outcome results
None listed