Clinical trial: Efficacy of Interleukin-2 Gargle in the Treatment of Oral Mucosa Lesion in Pemphigus Vulgaris (NCT04023149)

Eligibility 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers.  The rashes are mildly itchy. The patient has no other medical conditions and takes no medications.  Vital signs are normal.  On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer.  There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance.

Patient description (patient's own words): I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction.

Does the patient match the trial criteria? 0