Status:
UNKNOWN
Efficacy of Interleukin-2 Gargle in the Treatment of Oral Mucosa Lesion in Pemphigus Vulgaris
Lead Sponsor:
Second Xiangya Hospital of Central South University
Conditions:
Pemphigus Vulgaris
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 vulga...
Detailed Description
Backgrounds: Pemphigus vulgaris (PV) is a life-threatening autoimmune bullous skin disease characterized by blisters or bullae on the skin and mucosal membranes. The formation of painful erosion surfa...
Eligibility Criteria
Inclusion
- Age: between 18 years and 70 years;
- 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.
- Visible oral mucosa lesion due to pemphigus;
- Mucosal-dominant PV or moderate mucocutaneous PV (PDAI score: 15-45);
- Written informed consent was obtained, volunteer to participate in the project and complete as required.
Exclusion
- Patients with severe diseases of heart, brain, lungs, liver, kidney or blood system; patients experienced organ transplantation;
- Patients with any acute severe infection such as pyemia and cellulitis, active tuberculosis, or an infection history of human immunodeficiency virus (HIV);
- 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;
- Patients with persistent ventricular tachycardia, uncontrolled arrhythmias, chest pain with ECG changes, angina or myocardial infarction, cardiac tamponade;
- Patients with nausea, vomiting, peptic ulcer or intestinal ischemia;
- Patients with drug abuse, alcohol abuse, or mental disorders that are unable to cooperate or adhere to treatment;
- Pregnant women, lactating women or women who are ready to conceive within 3 months;
- Patients receiving treatment of immunosuppressants in the last 3 months;
- Patients receiving continuous treatment of glucocorticoids with a dose of more than 0.75 mg/kg/d in the last 2 weeks;
- Patients with oral fungal infection but don't receive antifungal therapy;
- Participated in other clinical trials within 3 months before the screening.
Key Trial Info
Start Date :
April 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04023149
Start Date
April 2 2020
End Date
December 1 2021
Last Update
February 2 2021
Active Locations (1)
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1
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011