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CTRI Number  CTRI/2023/06/054423 [Registered on: 26/06/2023] Trial Registered Prospectively
Last Modified On: 23/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing the effectiveness and safety profile of moderate to severe alopecia areata patients receiving oral methotrexate and oral tofacitinib  
Scientific Title of Study   A study to compare the efficacy and safety of oral methotrexate versus tofacitinib in patients with moderate to severe alopecia areata 
Trial Acronym  Not applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mude Hemalatha 
Designation  Junior resident 
Affiliation  PGIMER 
Address  Department of Dermatology, Room no 8, 2nd floor, Nehru hospital, PGIMER, Madhya Marg, Sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  9392468144  
Fax    
Email  drhemalatha0810@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sunil Dogra 
Designation  Professor and guide 
Affiliation  PGIMER 
Address  Department of Dermatology, Room no 8, 2nd floor, Faculty office, Nehru hospital, PGIMER, Madhya Marg, Sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  9855005941  
Fax    
Email  sundogra@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Mude Hemalatha 
Designation  Junior resident 
Affiliation  PGIMER 
Address  Department of Dermatology, Room no 8, 2nd floor, Nehru hospital, PGIMER, Madhya Marg, Sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  drhemalatha0810@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical and Research, Madhya Marg, sector 12, chandigarh-160012 
 
Primary Sponsor  
Name  PGIMER, Chandigarh 
Address  Department of Dermatology, PGIMER, Madhya Marg, Sector 12, Chandigarh, 160012 
Type of Sponsor  Research institution and hospital 
 
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 Mude Hemalatha  Post Graduate Institute of Medical Education and Research  Room no 5022, Department of Dermatology, New OPD,PGIMER, Madhya marg, sector 12
Chandigarh
CHANDIGARH 		 9392468144

drhemalatha0810@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Postgraduate Institute of Medical Education and Research, Chandigarh Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L639||Alopecia areata, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Methotrexate  Tab Methotrexate 0.3-0.5 mg/kg will be given for 6 months after physical examination and various laboratory tests such as hemogram, liver function test and renal function test 
Comparator Agent  Tofacitinib   oral Tofacitinib will be given as 5mg BD for 6 months after a physical examination and various laboratory tests including hemogram, renal function test, liver function test, and lipid profile 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients with SALT (severity of alopecia tool) score ≥ 40 at the time of screening. (SALT score 100 is the maximum score, and SALT 0 is the minimum score)
2. Total duration of disease more than 6 months
3. Patients with minimal/ no response after an adequate trial of topical therapy
 
 
ExclusionCriteria 
Details  1. Pregnant and lactating women
2. Women with childbearing potential who are unwilling to follow reliable methods of contraception
3. Patients on topical treatment for alopecia in the past fifteen days or on systemic treatment for one month.
4. Patients with severe hepatic renal or other systemic diseases such as heart disease, peptic ulcer disease, stroke, chronic lung disease, and AIDS.
5. Pre-existing malignancy, bone marrow suppression, and thromboembolic events
6. Patients who are not willing to participate in the trial
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
•This will be assessed by comparing the proportion of patients in the two arms who achieve SALT score ≤ 20 at the end of therapy  At the end of 6 months of treatment  
 
Secondary Outcome  
Outcome  TimePoints 
•Scalp hair assessment Patient-reported outcome (PRO): proportion of patients achieving a PRO score of 0 or 1 or 2 points improvement in patients who had a baseline score of 3 in two arms at 6 months
•Proportion of patients who achieve 90% improvement in SALT score in two arms
•Proportion of patients achieving a SALT score 20 at 3 months.
•Percentage change in the SALT Score from baseline to 6 months
•Change in DLQI & PHQ scores at 24 weeks and 36 weeks from baseline
 		 Baseline, 6 months (end of treatment) & 9 months (end of follow-up) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   06/07/2023 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Alopecia areata is an autoimmune disorder affecting hair-bearing areas, leading to psychosocial morbidity.  In moderate to severe alopecia cases, conventional treatments are less successful and have greater side effects, rendering them challenging to treat. in this study, we are using two drugs named Tofacitinib and Methotrexate and we want to demonstrate the efficacy of methotrexate as monotherapy and also compare it to newer modalities like tofacitinib because there haven’t been any previous studies comparing the two. This study aims to prove that methotrexate is non-inferior to tofacitinib in moderate to severe AA patients. So that we can use methotrexate widely in AA cases. This study will also add scalp ALP activity in alopecia areata, as there aren’t many studies on this topic, and ALP  activity can be used as a biomarker in the future.

 
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