Trial Outcomes & Findings for Comparison of Efficacy of Methotrexate and Azathioprine in Patients With Chronic Actinic Dermatitis: A Randomized Controlled Trial (NCT NCT06476366)
NCT ID: NCT06476366
Last Updated: 2025-08-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
20 participants
Primary outcome timeframe
6 months
Results posted on
2025-08-17
Participant Flow
10 patients recruited in each arm after informed consent as detailed in the attached document
Group A was administered oral methotrexate 10mg/week after a test dose while group B was administered tablet azathioprine at a dose of 0.3mg/kg daily after testing for TPMT levels. Both group of patients were advised regarding strict sun protection measures (sunblock, hats, sunglasses). The baseline investigations for both groups included complete blood picture (CBC), liver function tests (LFTs), renal function tests (RFTs), electrocardiogram, chest X-ray and urine analysis
Participant milestones
| Measure |
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
|
Azathioprine
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,
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
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
|
Azathioprine
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,
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Out of a total of 20 patients recruited, 4 were lost to follow-up (three from AZT arm and one from MTX arm). One patient developed anemia while on methotrexate and the treatment was discontinued. The final analysis included a total of 15 patients (7 from AZT arm and 8 from MTX arm).
Baseline characteristics by cohort
| Measure |
Methotrexate Arm
n=8 Participants
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
|
Azathioprine
n=7 Participants
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,
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants • Out of a total of 20 patients recruited, 4 were lost to follow-up (three from AZT arm and one from MTX arm). One patient developed anemia while on methotrexate and the treatment was discontinued. The final analysis included a total of 15 patients (7 from AZT arm and 8 from MTX arm).
|
0 Participants
n=7 Participants • Out of a total of 20 patients recruited, 4 were lost to follow-up (three from AZT arm and one from MTX arm). One patient developed anemia while on methotrexate and the treatment was discontinued. The final analysis included a total of 15 patients (7 from AZT arm and 8 from MTX arm).
|
0 Participants
n=15 Participants • Out of a total of 20 patients recruited, 4 were lost to follow-up (three from AZT arm and one from MTX arm). One patient developed anemia while on methotrexate and the treatment was discontinued. The final analysis included a total of 15 patients (7 from AZT arm and 8 from MTX arm).
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=8 Participants • Out of a total of 20 patients recruited, 4 were lost to follow-up (three from AZT arm and one from MTX arm). One patient developed anemia while on methotrexate and the treatment was discontinued. The final analysis included a total of 15 patients (7 from AZT arm and 8 from MTX arm).
|
3 Participants
n=7 Participants • Out of a total of 20 patients recruited, 4 were lost to follow-up (three from AZT arm and one from MTX arm). One patient developed anemia while on methotrexate and the treatment was discontinued. The final analysis included a total of 15 patients (7 from AZT arm and 8 from MTX arm).
|
7 Participants
n=15 Participants • Out of a total of 20 patients recruited, 4 were lost to follow-up (three from AZT arm and one from MTX arm). One patient developed anemia while on methotrexate and the treatment was discontinued. The final analysis included a total of 15 patients (7 from AZT arm and 8 from MTX arm).
|
|
Age, Categorical
>=65 years
|
4 Participants
n=8 Participants • Out of a total of 20 patients recruited, 4 were lost to follow-up (three from AZT arm and one from MTX arm). One patient developed anemia while on methotrexate and the treatment was discontinued. The final analysis included a total of 15 patients (7 from AZT arm and 8 from MTX arm).
|
4 Participants
n=7 Participants • Out of a total of 20 patients recruited, 4 were lost to follow-up (three from AZT arm and one from MTX arm). One patient developed anemia while on methotrexate and the treatment was discontinued. The final analysis included a total of 15 patients (7 from AZT arm and 8 from MTX arm).
|
8 Participants
n=15 Participants • Out of a total of 20 patients recruited, 4 were lost to follow-up (three from AZT arm and one from MTX arm). One patient developed anemia while on methotrexate and the treatment was discontinued. The final analysis included a total of 15 patients (7 from AZT arm and 8 from MTX arm).
|
|
Sex: Female, Male
Female
|
0 Participants
n=8 Participants • Out of a total of 20 patients recruited, 4 were lost to follow-up (three from AZT arm and one from MTX arm). One patient developed anemia while on methotrexate and the treatment was discontinued. The final analysis included a total of 15 patients (7 from AZT arm and 8 from MTX arm).
|
0 Participants
n=7 Participants • Out of a total of 20 patients recruited, 4 were lost to follow-up (three from AZT arm and one from MTX arm). One patient developed anemia while on methotrexate and the treatment was discontinued. The final analysis included a total of 15 patients (7 from AZT arm and 8 from MTX arm).
|
0 Participants
n=15 Participants • Out of a total of 20 patients recruited, 4 were lost to follow-up (three from AZT arm and one from MTX arm). One patient developed anemia while on methotrexate and the treatment was discontinued. The final analysis included a total of 15 patients (7 from AZT arm and 8 from MTX arm).
|
|
Sex: Female, Male
Male
|
8 Participants
n=8 Participants • Out of a total of 20 patients recruited, 4 were lost to follow-up (three from AZT arm and one from MTX arm). One patient developed anemia while on methotrexate and the treatment was discontinued. The final analysis included a total of 15 patients (7 from AZT arm and 8 from MTX arm).
|
7 Participants
n=7 Participants • Out of a total of 20 patients recruited, 4 were lost to follow-up (three from AZT arm and one from MTX arm). One patient developed anemia while on methotrexate and the treatment was discontinued. The final analysis included a total of 15 patients (7 from AZT arm and 8 from MTX arm).
|
15 Participants
n=15 Participants • Out of a total of 20 patients recruited, 4 were lost to follow-up (three from AZT arm and one from MTX arm). One patient developed anemia while on methotrexate and the treatment was discontinued. The final analysis included a total of 15 patients (7 from AZT arm and 8 from MTX arm).
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
50% improvement in Eczema Area and Severity Index (EASI-50)
|
25.325 units on a scale
n=8 Participants • Out of a total of 20 patients recruited, 4 were lost to follow-up (three from AZT arm and one from MTX arm). One patient developed anemia while on methotrexate and the treatment was discontinued. The final analysis included a total of 15 patients (7 from AZT arm and 8 from MTX arm).
|
25.128 units on a scale
n=7 Participants • Out of a total of 20 patients recruited, 4 were lost to follow-up (three from AZT arm and one from MTX arm). One patient developed anemia while on methotrexate and the treatment was discontinued. The final analysis included a total of 15 patients (7 from AZT arm and 8 from MTX arm).
|
25.233 units on a scale
n=15 Participants • Out of a total of 20 patients recruited, 4 were lost to follow-up (three from AZT arm and one from MTX arm). One patient developed anemia while on methotrexate and the treatment was discontinued. The final analysis included a total of 15 patients (7 from AZT arm and 8 from MTX arm).
|
PRIMARY outcome
Timeframe: 6 monthsEASI-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.
Outcome measures
| Measure |
Methotrexate Arm
n=8 Participants
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
|
Azathioprine
n=7 Participants
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,
|
|---|---|---|
|
50% Reduction in the Eczema Area and Severity Index Score (EASI-50)
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 monthsInvestigator 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)
Outcome measures
| Measure |
Methotrexate Arm
n=8 Participants
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
|
Azathioprine
n=7 Participants
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,
|
|---|---|---|
|
Investigator Global Assessment (IGA) Score of 0-2
|
5 Participants
|
3 Participants
|
Adverse Events
Methotrexate Arm
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Azathioprine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methotrexate Arm
n=10 participants at risk
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
|
Azathioprine
n=10 participants at risk
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,
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia/pancytopenia during treatment
|
10.0%
1/10 • Number of events 1 • From enrollment to end of followup, upto 24 weeks
|
0.00%
0/10 • From enrollment to end of followup, upto 24 weeks
|
Other adverse events
| Measure |
Methotrexate Arm
n=10 participants at risk
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
|
Azathioprine
n=10 participants at risk
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,
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Body aches and myalgias
|
10.0%
1/10 • From enrollment to end of followup, upto 24 weeks
|
20.0%
2/10 • From enrollment to end of followup, upto 24 weeks
|
|
Gastrointestinal disorders
Gastritis, nausea, vomiting
|
0.00%
0/10 • From enrollment to end of followup, upto 24 weeks
|
10.0%
1/10 • From enrollment to end of followup, upto 24 weeks
|
Additional Information
Dr Ahsan Tameez-ud-din
Department of Dermatology, Emirates Military Hospital
Phone: 051-9293480
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place