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CTRI Number  CTRI/2019/01/017217 [Registered on: 23/01/2019] Trial Registered Prospectively
Last Modified On: 31/08/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of efficacy and safety of azathioprine and methotrexate in patients of hand eczema. 
Scientific Title of Study   A randomized controlled study to compare efficacy and safety of azathioprine and methotrexate in patients of hand eczema. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanjeev Handa 
Designation  Professor and Head 
Affiliation  Postgraduate Institute of Medical education and Research 
Address  Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical education and Research

Chandigarh
CHANDIGARH
160012
India 
Phone  0172-2756564  
Fax    
Email  handa_sanjeev@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Sanjeev Handa 
Designation  Professor and Head 
Affiliation  Postgraduate Institute of Medical education and Research 
Address  Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical education and Research

Chandigarh
CHANDIGARH
160012
India 
Phone  0172-2756564  
Fax    
Email  handa_sanjeev@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Sanjeev Handa 
Designation  Professor and Head 
Affiliation  Postgraduate Institute of Medical education and Research 
Address  Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical education and Research

Chandigarh
CHANDIGARH
160012
India 
Phone  0172-2756564  
Fax    
Email  handa_sanjeev@yahoo.com  
 
Source of Monetary or Material Support  
Postgraduate Institute of Medical Education and Research Chandigarh  
 
Primary Sponsor  
Name  Postgraduate Institute of Medical Education and Research 
Address  Sector 12, Chandigarh 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjeev Handa  Postgraduate Institute of Medical education and Research  Department of Dermatology, Room No. 5005,5007, Level 5,New OPD block PGIMER Chandigarh.
Chandigarh
CHANDIGARH 		 01722756564

handa_sanjeev@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, PGIMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L308||Other specified dermatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Azathioprine  All patients who meet the eligibility criteria during the screening visit will be randomly assigned to one of the two treatment groups of 40 patients each and this group will receive azathioprine 50 mg once a day for initial 2 weeks followed by 50 mg twice a day for 10 weeks. Active concomitant topical therapy in the form of emollients and anti-histamines will be allowed but topical and systemic immunosuppressant and anti-inflammatory treatments will not be allowed during study period. A wash out period of 4 weeks will be given for patients who were on any systemic treatments and 1 week for topical preparations. 
Intervention  Methotrexate   All patients who meet the eligibility criteria during the screening visit will be randomly assigned to one of the two treatment groups of 40 patients each and one group will receive methotrexate 0.4mg/kg body weight/ weekly for 12 weeks. Active concomitant topical therapy in the form of emollients and anti-histamines will be allowed but topical and systemic immunosuppressant and anti-inflammatory treatments will not be allowed during study period. A wash out period of 4 weeks will be given for patients who were on any systemic treatments and 1 week for topical preparations. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients diagnosed as moderate to severe hand eczema (HECSI score >12).
Age >18 years. 
 
ExclusionCriteria 
Details  1. Patients with hepatic/ renal disease/pulmonary fibrosis.
2. Severe anaemia, leucopenia or thrombocytopenia.
3. Active infectious disease or immune system deficiency including AIDS.
4. Pregnant or lactating women.
5. Significant abnormalities in liver function (serum bilirubin, AST, ALT, and ALP> 1.5 times the upper limit of normal), viral hepatitis or cirrhosis.
6. H/o excessive alcohol consumption.
7. H/o intolerance/hypersensitivity to azathioprine and/or methotrexate. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the clinical and functional outcome in each group, as assessed by HECSI and DLQI.
To compare the safety and tolerability of each drug by regular evaluation of clinical and biochemical parameters. 		 week 2, 4, 8 and 12
 
 
Secondary Outcome  
Outcome  TimePoints 
〈 Evaluate the clinicodemographic factors predicting response in each group.
To study the MOAHLFA index for demographic characteristics of patients. 		 week 2,4,8 and 12 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   28/01/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Hand eczema is an inflammatory skin disorder, clinically characterized by erythema, infiltration, hyperkeratosis, oedema, and vesicles. Secondary signs may be scaling, hyperkeratotic areas, fissures, erosions, and bacterial infections, chiefly with Staphylococcus aureus. In addition to the hands, the wrists and the forearms are often involved. Hand eczema is common, with a 1-year prevalence of approximately 10% in the adult population.Hand eczema is typically a dynamic condition extending over years, and its morphology may vary over time, both clinically and histologically. Erythema, oedema and vesicles are characteristic of acute eczema, whereas infiltration, hyperkeratosis and fissures are seen in chronic eczema. Hand eczema generally begins as acute eczema and then passes into a phase with chronic changes, sometimes with periods of acute eruptions. Important symptoms in patients of hand eczema are itching and pain in fissures if present.

      Patients with hand eczema experience significantly diminished health related quality of life (QOL) resulting in physical and mental disability even though it involves a relatively small percentage of the body surface area. This is often comparable with other chronic diseases (e.g. diabetes, depression, heart disease). Hand eczema is often notoriously difficult to treat and unresponsive to traditional topical agents. The treatment of hand eczema must be tailored to the individual patient. Hand eczema of recent onset should be treated quickly and effectively to prevent chronicity. At the same time, an effort should be made to determine the aetiology of the eczema, and instruction on skin care and prevention should be given. When treatment is being chosen, the severity of the eczema, whether it is acute or chronic, and its morphology should be taken into account. There is no consensus about the treatment of hand eczema and current therapeutic options include avoidance of allergens and irritants, emollients, topical and systemic corticosteroids and other immunosuppressive drugs. There is limited randomized controlled trial (RCT) data regarding the use of systemic immunosuppressive agents for hand eczema. Methotrexate is an off-label treatment option for chronic hand eczema, although the effectiveness is only discussed in small case series. An RCT comparing azathioprine 50 mg daily and a very potent topical corticosteroid with the very potent topical corticosteroid alone suggests possible additive benefit from low‐dose azathioprine.There are no studies that have compared Azathioprine with Methotrexate in the management of hand eczema hence in this study, we intend to compare the efficacy and safety of Azathioprine versus Methotrexate in patients of hand eczema. 
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