The Efficacy and Safety of Oral Apremilast in comparison to that of Oral Methotrexate in the management of Interface Dermatitis

Phase 4

• Conditions: Health Condition 1: L308- Other specified dermatitis

• Registration Number: CTRI/2022/01/039139
• Lead Sponsor: Krishna institute of medical sciences karad

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decrease in body surface area covered by skin lesions <br/ ><br>Improvement in PGA scores <br/ ><br>Timepoint: Baseline <br/ ><br>2 weeks <br/ ><br>4 weeks <br/ ><br>8 weeks <br/ ><br>12 weeks <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Oral Apremilast having same or better efficacy and safety profile than oral Methotrexate in the treatment of interface dermatitisTimepoint: 3 months