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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/01/039139

Enrollment

Registered

2022-01-04

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L308- Other specified dermatitis

Interventions

Intervention1: Apremilast: Oral Apremilast 10mg twice daily to 30mg twice daily for 3 months Dosing depending on patient tolerance and clinical improvement Control Intervention1: Methotrexate: Oral me

Eligibility

Inclusion criteria

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

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 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

Design outcomes

Primary

Measure	Time frame
Decrease in body surface area covered by skin lesions Improvement in PGA scores Timepoint: Baseline 2 weeks 4 weeks 8 weeks 12 weeks	—

Secondary

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

Countries

India

Contacts

Public ContactDr Nikhil Girish

Krishna institute of medical sciences, karad

jamalevarsha@gmail.com9822572887

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026