Comparison of Efficacy of Methotrexate and Azathioprine in Patients With Chronic Actinic Dermatitis: A Randomized Controlled Trial

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-14

Study Completion Date

2025-07-02

Brief Summary

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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 10mg/week after a test dose while group B will be administered tablet azathioprine at a dose of 0.3mg/kg 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 Eczema Area and Severity Index (EASI) score will be calculated, Investigator global assesment (IGA) score will also be calculated .

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Detailed Description

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Weekly complete blood picture (CBC) will be done until the last dose escalation for group B patients. Both group of patients will be advised regarding strict sun protection measures (sunblock, hats, sunglasses). The baseline investigations for both groups included CBC, liver function tests (LFTs), renal function tests (RFTs), electrocardiogram, chest X-ray and urine analysis while 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. EASI score will be calculated at baseline and at subsequently at each follow-up visit.

A comparison from the EASI score from the last visit will be made at each follow-up to assess whether any patient achieved the primary outcome of EASI-50 (50% improvement in EASI score from baseline). Investigator global assessment (IGA) score will be used as a secondary outcome measure. It is a subjective measure of disease severity which is assessed by the physician on patient's every visit. It ranges from 0 to 4 (0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe). An IGA score of 0-2 will be considered as the outcome measure. Patients will be also asked for any specific side-effects of the treatment at every follow-up. The data including the demographic profile of the participants will be recorded on a printed form. The data will be kept under lock and key and will be available only to the treating physician and the research team.

Conditions

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Chronic Actinic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two arms of the study will be as follows:

Group A: Methotrexate 10mg/week Group B: Azathioprine 0.3mg/kg daily

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Methotrexate arm

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 10mg/week after a test dose. Starting dose will be 2.5mg/week and dose will be escalated by 2.5mg/week till the final dose of 10mg/week

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

Methotrexate will be started at 5mg/week and dose escalated by 2.5mg weekly to ultimately 10mg/week. Tablet Folic acid 0.5mg will be given orally daily, skipping the day of methotrexate

Azathioprine

group B will be administered tablet azathioprine at a dose of 0.3mg/kg daily after TPMT testing. 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,

Group Type ACTIVE_COMPARATOR

Azathioprine

Intervention Type DRUG

azathioprine will be started at 0.3mg/kg orally daily. Anticipated response is after atleast 1 month so testing will be done thereafter ( after checking TPMT levels)

Interventions

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Azathioprine

azathioprine will be started at 0.3mg/kg orally daily. Anticipated response is after atleast 1 month so testing will be done thereafter ( after checking TPMT levels)

Intervention Type DRUG

Methotrexate

Methotrexate will be started at 5mg/week and dose escalated by 2.5mg weekly to ultimately 10mg/week. Tablet Folic acid 0.5mg will be given orally daily, skipping the day of methotrexate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All newly diagnosed as well as patients with an established diagnosis of CAD presenting to the outpatient department or the emergency department of PEMH or CMH will be included in the study.

Exclusion Criteria

* Patients with coexisting conditions requiring immunosuppressants will be excluded from the study. Patients with dementia or any other neuropsychiatric disorder will also be excluded.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No