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

NCT06476366 | Completed Early Phase 1 Results

• 1 other identifier: DERM9512866
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.Is methotrexate safe and efficacious in treating CAD?
2. 2.Is there a difference in efficacy of methotrexate and azathioprine in the treatment of this disease?

Conditions

Chronic Actinic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 50% Reduction in the Eczema Area and Severity Index Score (EASI-50)

  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.

  6 months

Secondary Outcomes (1)

• Investigator Global Assessment (IGA) Score of 0-2

  6 months

Study Arms (2)

Methotrexate arm

ACTIVE COMPARATOR

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

Drug: Methotrexate

Azathioprine

ACTIVE COMPARATOR

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,

Drug: Azathioprine

Interventions

Azathioprine 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)

Azathioprine

Methotrexate 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

Methotrexate arm

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pak Emirates Military Hospital: lead

Study Sites (1)

Pak Emirates Military Hospital

Rawalpindi, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Photosensitivity Disorders

Interventions

Azathioprine; Methotrexate

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Aminopterin; Pterins; Pteridines

Limitations and Caveats

Lower than expected sample size may impact on the generalizability of results

Results Point of Contact

• Title: Dr Ahsan Tameez-ud-din
• Organization: Department of Dermatology, Emirates Military Hospital

ahsantameezuddinmalik@gmail.com

051-9293480

Study Officials

• Ahsan Tameez-ud-din

  Pak Emirates Military Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registrar Dermatology

Model Details: Two arms of the study will be as follows: Group A: Methotrexate 10mg/week Group B: Azathioprine 0.3mg/kg daily

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: July 14, 2024
• Primary Completion: July 2, 2025
• Study Completion: July 2, 2025
• Last Updated: August 17, 2025
• Results First Posted: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)