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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:
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 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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, |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment (IGA) Score of 0-2 | 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) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahsan Tameez-ud-din | Pak Emirates Military Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pak Emirates Military Hospital | Rawalpindi | Punjab Province | Pakistan |
No plan to share the data.
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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
25 patients recruited in each arm after informed consent as detailed in the attached document
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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, |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Out of a total of 50 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 45 patients (22 from AZT arm and 23 from MTX arm).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Azathioprine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 6 months |
|
From enrollment to end of followup, upto 24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia/pancytopenia during treatment | Blood and lymphatic system disorders | Systematic Assessment | Patient was withdrawn from the study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Body aches and myalgias | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Lower than expected sample size may impact on the generalizability of results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ahsan Tameez-ud-din | Department of Dermatology, Emirates Military Hospital | 051-9293480 | 312 | ahsantameezuddinmalik@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 14, 2024 | Aug 14, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D010787 | Photosensitivity Disorders |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D001379 | Azathioprine |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D015122 | Mercaptopurine |
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Two arms of the study will be as follows:
Group A: Methotrexate 10mg/week Group B: Azathioprine 0.3mg/kg daily
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| 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 |
|
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, |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Out of a total of 50 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 45 patients (22 from AZT arm and 23 from MTX arm). | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| 50% improvement in Eczema Area and Severity Index (EASI-50) | EASI-50 implies 50% reduction in EASI score from baseline. 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. | Out of a total of 50 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 45 patients (22 from AZT arm and 23 from MTX arm). | Mean | Full Range | units on a scale |
|
| OG001 | 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, |
|
|
| Secondary | Investigator Global Assessment (IGA) Score of 0-2 | 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) | Posted | Count of Participants | Participants | 6 months |
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|
|
| 0 |
| 25 |
| 1 |
| 25 |
| 3 |
| 25 |
| EG001 | 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, | 0 | 25 | 0 | 25 | 2 | 25 |
|
| Gastritis, nausea, vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |