Chronic Actinic Dermatitis
Conditions
Brief 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 .
Detailed description
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.
Interventions
DRUGMethotrexate
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
DRUGAzathioprine
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)
Sponsors
Pak Emirates Military Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Two arms of the study will be as follows: Group A: Methotrexate 10mg/week Group B: Azathioprine 0.3mg/kg daily
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 50% Reduction in the Eczema Area and Severity Index Score (EASI-50) | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Assessment (IGA) Score of 0-2 | 6 months | 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) |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORAhsan Tameez-ud-din
Pak Emirates Military Hospital
Participant flow
Recruitment details
25 patients recruited in each arm after informed consent as detailed in the attached document
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| 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, | 7 |
| Total | 15 |
Baseline characteristics
| Characteristic | Total | Azathioprine | Methotrexate Arm |
|---|---|---|---|
| 50% improvement in Eczema Area and Severity Index (EASI-50) | 22.004 units on a scale | 22.0227 units on a scale | 21.9870 units on a scale |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 6 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 16 Participants | 18 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 45 Participants | 22 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 3 / 25 | 2 / 25 |
| serious Total, serious adverse events | 1 / 25 | 0 / 25 |
Outcome results
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate Arm | 50% Reduction in the Eczema Area and Severity Index Score (EASI-50) | 3 Participants |
| Azathioprine | 50% Reduction in the Eczema Area and Severity Index Score (EASI-50) | 2 Participants |
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)
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methotrexate Arm | Investigator Global Assessment (IGA) Score of 0-2 | 5 Participants |
| Azathioprine | Investigator Global Assessment (IGA) Score of 0-2 | 3 Participants |