| CTRI Number |
CTRI/2022/01/039139 [Registered on: 04/01/2022] Trial Registered Prospectively |
| Last Modified On: |
28/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The Efficacy and Safety of Oral Apremilast in comparison to that of Oral Methotrexate in the management of Interface Dermatitis |
|
Scientific Title of Study
|
Efficacy and Tolerability of Oral Apremilast VS Oral Methotrexate in Interface dermatitis- A Randomized study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nikhil Girish |
| Designation |
Resident |
| Affiliation |
Krishna institute of medical sciences, karad |
| Address |
Department of dermatology, OPD 29, Krishna institute of medical sciences, karad
Satara
MAHARASHTRA
415539
India |
| Phone |
9611863225 |
| Fax |
|
| Email |
niks443@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varsha Jamale |
| Designation |
Associate professor |
| Affiliation |
Krishna institute of medical sciences, karad |
| Address |
Department of dermatology, OPD 29, Krishna institute of medical sciences, karad
Satara
MAHARASHTRA
415539
India |
| Phone |
9822572887 |
| Fax |
|
| Email |
jamalevarsha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikhil Girish |
| Designation |
Resident |
| Affiliation |
Krishna institute of medical sciences, karad |
| Address |
Department of dermatology, OPD 29, Krishna institute of medical sciences, karad
Satara
MAHARASHTRA
415539
India |
| Phone |
9611863225 |
| Fax |
|
| Email |
niks443@gmail.com |
|
|
Source of Monetary or Material Support
|
| Krishna institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
Krishna institute of medical sciences karad |
| Address |
Krishna institute of medical sciences, karad, agashivnagar, maharastra - 415539 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nikhil Girsh |
Krishna institute of medical sciences |
OPD 29, Department of Dermatology, Krishna institute of medical sciences, karad
Satara
MAHARASHTRA |
9611863225
Niks443@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Krishna institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L308||Other specified dermatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Apremilast |
Oral Apremilast 10mg twice daily to 30mg twice daily for 3 months
Dosing depending on patient tolerance and clinical improvement |
| Comparator Agent |
Methotrexate |
Oral methotrexate 7.5mg weekly to 15mg weekly for a period of 3 months. Dosage depending on tolerance and clinical requirements |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Decrease in body surface area covered by skin lesions
Improvement in PGA scores
|
Baseline
2 weeks
4 weeks
8 weeks
12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oral Apremilast having same or better efficacy and safety profile than oral Methotrexate in the treatment of interface dermatitis |
3 months |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
13/01/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study titled ‘ Efficacy and tolerability of Oral Apremilast VS Oral Methotrexate in interface dermatitis - A Randomized Study’ aims to compare the efficacy and safety profile of the above mentioned drugs in the treatment of interface dermatitis. Oral methotrexate is currently the gold standard treatment for diseases showing interface dermatitis patterns. Oral Apremilast is proven to have fewer adverse effects than methotrexate. |