Ignite Creation Date:
2024-07-17 @ 11:10 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476366
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-21
Brief Title:
Comparison of Efficacy of Methotrexate and Azathioprine in Patients With Chronic Actinic Dermatitis A Randomized Controlled Trial
Sponsor:
Pak Emirates Military Hospital
Organization:
Pak Emirates Military Hospital
Study Overview
Official Title:
Comparison of Efficacy of Methotrexate and Azathioprine in Patients With Chronic Actinic Dermatitis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to evaluate the efficacy and safety of AZT and MTX in patients with Chronic Actinic Dermatitis CAD These drugs have been used successfully as steroid-sparing alternatives in a variety of related dermatoses and this trial may help in paving the path towards the ubiquitous use of these cost-effective and relatively safer drugs in CAD patients of our population The researchers will try to answer the following questions
1 Is methotrexate safe and efficacious in treating CAD
2 Is there a difference in efficacy of methotrexate and azathioprine in the treatment of this disease
After the enrollment of patients and taking consent participants will be divided in two treatment groups via lottery method Group A will be administered oral methotrexate 10mgweek after a test dose while group B will be administered tablet azathioprine at a dose of 03mgkg daily after Both group of patients will be advised regarding strict sun protection measures sunblock hats sunglasses etc The baseline investigations for both groups will include complete blood picture CBC liver function tests LFTs renal function tests RFTs electrocardiogram chest X-ray and urine analysis while thiopurine methyltransferase TPMT levels will be assessed specifically for group B patients The patients will be followed up at week 4 12 and 24 CBC RFTs and LFTs will be done at each follow-up and EASI score will be calculated
1 Is methotrexate safe and efficacious in treating CAD
2 Is there a difference in efficacy of methotrexate and azathioprine in the treatment of this disease
After the enrollment of patients and taking consent participants will be divided in two treatment groups via lottery method Group A will be administered oral methotrexate 10mgweek after a test dose while group B will be administered tablet azathioprine at a dose of 03mgkg daily after Both group of patients will be advised regarding strict sun protection measures sunblock hats sunglasses etc The baseline investigations for both groups will include complete blood picture CBC liver function tests LFTs renal function tests RFTs electrocardiogram chest X-ray and urine analysis while thiopurine methyltransferase TPMT levels will be assessed specifically for group B patients The patients will be followed up at week 4 12 and 24 CBC RFTs and LFTs will be done at each follow-up and EASI score will be calculated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None