Efficacy of Interleukin-2 Gargle in the Treatment of Oral Mucosa Lesion in Pemphigus Vulgaris

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This clinical study will test the short-term efficacy of interleukin-2 gargle combined with systemic use of glucocorticoids in the treatment of oral mucosal lesions in mucosal-dominant pemphigus vulgaris and moderate mucocutaneous pemphigus vulgaris.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Xiangya Hospital of Central South University
• Treatments: Aldesleukin; Glucocorticoids; Interleukin-2; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Age: between 18 years and 70 years;

2. Patients definitely diagnosed with pemphigus vulgaris according to 'Diagnostic Criteria for Pemphigus Vulgaris (Autoimmune Disease Sub-Professional Committee of Dermatologist Branch of Chinese Medical Doctor Association)'; or pemphigus vulgaris has been diagnosed in the past.

3. Visible oral mucosa lesion due to pemphigus;

4. Mucosal-dominant PV or moderate mucocutaneous PV (PDAI score: 15-45);

5. Written informed consent was obtained, volunteer to participate in the project and complete as required.

Exclusion Criteria:

1. Patients with severe diseases of heart, brain, lungs, liver, kidney or blood system; patients experienced organ transplantation;

2. Patients with any acute severe infection such as pyemia and cellulitis, active tuberculosis, or an infection history of human immunodeficiency virus (HIV);

3. Patients with allergic skin diseases with obvious pruritus such as eczema or urticaria, blood routine examination show elevated eosinophils or have a clear history of allergy to rhIL-2;

4. Patients with persistent ventricular tachycardia, uncontrolled arrhythmias, chest pain with ECG changes, angina or myocardial infarction, cardiac tamponade;

5. Patients with nausea, vomiting, peptic ulcer or intestinal ischemia;

6. Patients with drug abuse, alcohol abuse, or mental disorders that are unable to cooperate or adhere to treatment;

7. Pregnant women, lactating women or women who are ready to conceive within 3 months;

8. Patients receiving treatment of immunosuppressants in the last 3 months;

9. Patients receiving continuous treatment of glucocorticoids with a dose of more than 0.75 mg/kg/d in the last 2 weeks;

10. Patients with oral fungal infection but don't receive antifungal therapy;

11. Participated in other clinical trials within 3 months before the screening.