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

Early Phase 1

Completed

• Conditions: Chronic Actinic Dermatitis
• Interventions: Drug: Methotrexate; Drug: Azathioprine

• Registration Number: NCT06476366
• Lead Sponsor: Pak Emirates Military Hospital

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 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 .

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-21
• Study First Posted: 2024-06-26
• Study Start: 2024-07-14
• Primary Completion: 2025-07-02
• Study Completion: 2025-07-02
• Results First Submitted: 2025-07-05
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Results First Posted: 2025-08-17
• Last Update Posted: 2025-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methotrexate arm	Methotrexate	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
Azathioprine	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,

Primary Outcome Measures

Name	Time	Method
50% Reduction in the Eczema Area and Severity Index Score (EASI-50)	6 months	EASI-50 means 50% reduction in the Eczema Area and Severity Index score from baseline score. EASI is a scale used to evaluate the degree and severity of eczema. The total EASI score is between 0 and 72 .; Mild disease: Patients with a score of 1.1-7.0 on the EASI scale will be classified as having mild disease.; Moderate disease: Patients with a score of 7.1 to 21.0 on the EASI scale will be classified as having moderate disease.; Severe disease: Patients with a score of 21.1-50.0 on the EASI scale will be classified as having severe disease.; Very Severe disease: Patients with a score of 50.1-72.0 on the EASI scale will be classified as having very severe disease.

Secondary Outcome Measures

Name	Time	Method
Investigator Global Assessment (IGA) Score of 0-2	6 months	Investigator global assessment (IGA) is a subjective measure of disease severity which is assessed by the physician on patient's visit. It ranges from 0 to 4 (0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe)

Trial Locations

Locations (1)

Pak Emirates Military Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan