Efficacy and Tolerability of Oral Apremilast VS Oral Methotrexate in Interface dermatitis- A Randomized study

Krishna institute of medical sciences karad0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年2月21日

试验速览

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•1. Patients with disorders which has been proven to be interface dermatitis on Histopathological examination
•2. Histopathological examination showing interface dermatitis type 2-5according to Le Boit PE classification (9)
•3. Have completed 14 years of age.(7)
•4. Have not taken any treatment, two months prior to the inclusion in study.
•5. Have given written consent before investigation
•6. Be able and willing , in the view of investigator , to comply all study procedures

•1. Patients with interface dermatitis type 1, according to Le Boit PE classification(9)
•2. Patients with interface dermatitis not requiring systemic management
•3. Hemoglobin < 8 gm/dl ,Total leukocyte count < 3500/ mm3, Platelet count < 100,000/mm3
•4. Elevation of hepatic enzymes (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) to more than twice the upper limit of normal or any deranged liver function tests.
•5. Hepatitis, active or recurrent, cirrhosis or excessive current alcohol intake.
•6. Use of other hepatotoxic drugs by the patient
•7. Positive hepatitis B, hepatitis C or HIV serology
•8. Pulmonary or extra-pulmonary active tuberculosis
•9. Deranged renal function test.
•10. Pregnancy or lactation or if patient is planning to conceive during the treatment period.
•11. Patient on other immunosuppressive drugs
•12. Recent live vaccination
•13. Unreliable patient
•14. Patients unwilling for monthly follow-ups.
•15. Patient with known hypersensitivity to drug.
•16. Patient with unrealistic expectation

发起方

Krishna institute of medical sciences karad