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

Last updated: July 7, 2024
Sponsor: Pak Emirates Military Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Eczema (Atopic Dermatitis - Pediatric)

Allergy

Rash

Treatment

Azathioprine

Methotrexate

Clinical Study ID

NCT06476366
DERM9512866
  • Ages 20-80
  • All Genders

Study 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 EASI score will be calculated,

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All newly diagnosed as well as patients with an established diagnosis of CADpresenting to the outpatient department or the emergency department of PEMH or CMHwill be included in the study.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 88
Treatment Group(s): 2
Primary Treatment: Azathioprine
Phase: 1
Study Start date:
July 14, 2024
Estimated Completion Date:
July 30, 2025

Connect with a study center

  • Pak Emirates Military Hospital

    Rawalpindi, Punjab
    Pakistan

    Active - Recruiting

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