Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-30 @ 3:19 AM
Study NCT ID:
NCT06476366
Status:
COMPLETED
Last Update Posted:
2025-08-17
First Post:
2024-06-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Efficacy of Methotrexate and Azathioprine in Patients With Chronic Actinic Dermatitis: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010787', 'term': 'Photosensitivity Disorders'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001379', 'term': 'Azathioprine'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D013872', 'term': 'Thionucleosides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ahsantameezuddinmalik@gmail.com', 'phone': '051-9293480', 'title': 'Dr Ahsan Tameez-ud-din', 'phoneExt': '312', 'organization': 'Department of Dermatology, Emirates Military Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Lower than expected sample size may impact on the generalizability of results'}}, 'adverseEventsModule': {'timeFrame': 'From enrollment to end of followup, upto 24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Methotrexate Arm', 'description': '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', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Azathioprine', 'description': '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,', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Body aches and myalgias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis, nausea, vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anemia/pancytopenia during treatment', 'notes': 'Patient was withdrawn from the study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '50% Reduction in the Eczema Area and Severity Index Score (EASI-50)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate Arm', 'description': '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'}, {'id': 'OG001', 'title': 'Azathioprine', 'description': '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,'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': '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 .\n\nMild disease: Patients with a score of 1.1-7.0 on the EASI scale will be classified as having mild disease.\n\nModerate disease: Patients with a score of 7.1 to 21.0 on the EASI scale will be classified as having moderate disease.\n\nSevere disease: Patients with a score of 21.1-50.0 on the EASI scale will be classified as having severe disease.\n\nVery Severe disease: Patients with a score of 50.1-72.0 on the EASI scale will be classified as having very severe disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Investigator Global Assessment (IGA) Score of 0-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate Arm', 'description': '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\n\nMethotrexate: Methotrexate will be started at 10mg/week and'}, {'id': 'OG001', 'title': 'Azathioprine', 'description': '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,\n\nAzathioprine: azathioprine will be started at 0.3mg/kg. Anticipated response is after atleast 1 month so testing will be done thereafter ( after checking initial safety profile)'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': "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)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Methotrexate Arm', 'description': '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'}, {'id': 'FG001', 'title': 'Azathioprine', 'description': '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,'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '10 patients recruited in each arm after informed consent as detailed in the attached document', 'preAssignmentDetails': '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'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Methotrexate Arm', 'description': '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'}, {'id': 'BG001', 'title': 'Azathioprine', 'description': '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,'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '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).'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': '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).'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': '50% improvement in Eczema Area and Severity Index (EASI-50)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25.325', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '30.4'}, {'value': '25.128', 'groupId': 'BG001', 'lowerLimit': '14.5', 'upperLimit': '44.7'}, {'value': '25.233', 'groupId': 'BG002', 'lowerLimit': '14.5', 'upperLimit': '44.7'}]}]}], 'paramType': 'MEAN', 'description': 'EASI-50 implies 50% reduction in EASI score from baseline. The total EASI score is between 0 and 72 .\n\nMild disease: Patients with a score of 1.1-7.0 on the EASI scale will be classified as having mild disease.\n\nModerate disease: Patients with a score of 7.1 to 21.0 on the EASI scale will be classified as having moderate disease.\n\nSevere disease: Patients with a score of 21.1-50.0 on the EASI scale will be classified as having severe disease.\n\nVery Severe disease: Patients with a score of 50.1-72.0 on the EASI scale will be classified as having very severe disease.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE', 'populationDescription': '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).'}], 'populationDescription': '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).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-06-14', 'size': 1232479, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-08-14T04:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two arms of the study will be as follows:\n\nGroup A: Methotrexate 10mg/week Group B: Azathioprine 0.3mg/kg daily'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2024-06-21', 'resultsFirstSubmitDate': '2025-07-05', 'studyFirstSubmitQcDate': '2024-06-21', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-08-14', 'studyFirstPostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '50% Reduction in the Eczema Area and Severity Index Score (EASI-50)', 'timeFrame': '6 months', 'description': '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 .\n\nMild disease: Patients with a score of 1.1-7.0 on the EASI scale will be classified as having mild disease.\n\nModerate disease: Patients with a score of 7.1 to 21.0 on the EASI scale will be classified as having moderate disease.\n\nSevere disease: Patients with a score of 21.1-50.0 on the EASI scale will be classified as having severe disease.\n\nVery Severe disease: Patients with a score of 50.1-72.0 on the EASI scale will be classified as having very severe disease.'}], 'secondaryOutcomes': [{'measure': 'Investigator Global Assessment (IGA) Score of 0-2', 'timeFrame': '6 months', 'description': "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)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Actinic Dermatitis']}, 'descriptionModule': {'briefSummary': '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:\n\n1. Is methotrexate safe and efficacious in treating CAD?\n2. Is there a difference in efficacy of methotrexate and azathioprine in the treatment of this disease?\n\nAfter 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 .', 'detailedDescription': "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.\n\nA 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Patients with coexisting conditions requiring immunosuppressants will be excluded from the study. Patients with dementia or any other neuropsychiatric disorder will also be excluded.'}, 'identificationModule': {'nctId': 'NCT06476366', 'briefTitle': 'Comparison of Efficacy of Methotrexate and Azathioprine in Patients With Chronic Actinic Dermatitis: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Pak Emirates Military Hospital'}, 'officialTitle': 'Comparison of Efficacy of Methotrexate and Azathioprine in Patients With Chronic Actinic Dermatitis', 'orgStudyIdInfo': {'id': 'DERM9512866'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Methotrexate arm', 'description': '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', 'interventionNames': ['Drug: Methotrexate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Azathioprine', 'description': '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,', 'interventionNames': ['Drug: Azathioprine']}], 'interventions': [{'name': 'Azathioprine', 'type': 'DRUG', 'description': '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)', 'armGroupLabels': ['Azathioprine']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Methotrexate arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Pak Emirates Military Hospital', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'overallOfficials': [{'name': 'Ahsan Tameez-ud-din', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pak Emirates Military Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pak Emirates Military Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Registrar Dermatology', 'investigatorFullName': 'Dr. Ahsan Tameez-ud-din', 'investigatorAffiliation': 'Pak Emirates Military Hospital'}}}}