Early Phase 1
N=50
Comparison of Efficacy of Methotrexate and Azathioprine in Patients With Chronic Actinic Dermatitis: A Randomized Controlled Trial
Chronic Actinic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT06476366 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Aug 2025
Primary outcome: Primary: 50% Reduction in the Eczema Area and Severity Index Score (EASI-50) — 12; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Azathioprine (Drug); Methotrexate (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Pak Emirates Military Hospital
- Primary completion
- Dec 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 50% Reduction in the Eczema Area and Severity Index Score (EASI-50) |
12; 9 | — |
| SECONDARY Investigator Global Assessment (IGA) Score of 0-2 |
15; 10 | — |
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 .
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06476366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.