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CTRI Number  CTRI/2022/12/048004 [Registered on: 12/12/2022] Trial Registered Prospectively
Last Modified On: 26/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of tofacitinib versus Betamethasone in alopecia areata. 
Scientific Title of Study   A comparative study evaluating the efficacy of oral tofacitinib versus oral mini pulse of corticosteroids in alopecia areata. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akhilesh Kumar Vimal  
Designation  Junior resident (PG Student) 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Dermatology, 1A AIIMS OPD Building, AIIMS, Basni, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9835198515  
Fax    
Email  akhileshvl62@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anupama Bains 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Dermatology, 1A AIIMS OPD Building, AIIMS, Basni, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  7297895727  
Fax    
Email  doc.trinity@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Akhilesh Kumar Vimal  
Designation  Junior resident (PG Student) 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Department of Dermatology, 1A AIIMS OPD Building, AIIMS, Basni, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9835198515  
Fax    
Email  akhileshvl62@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Basni, Jodhpur 342005 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Jodhpur 
Address  All India Institute of Medical Sciences, Basni, Jodhpur 342005 
Type of Sponsor  Government medical college 
 
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 Akhilesh Kumar Vimal  OPD, Department of Dermatology, Venereology and Leprology   1A, First floor, AIIMS OPD Building, AIIMS, Basni, Jodhpur
Jodhpur
RAJASTHAN 		 9835198515

akhileshvl62@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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 
Comparator Agent  OMP (Betamethasone)  After baseline blood investigations and chest x-ray, tablet betamethasone 5mg will be given twice a week and it will be continued till 4 months or till complete regrowth of hair occurs or whichever is earlier. 
Intervention  Tofacitinib  After baseline blood investigations and chest x-ray, tablet tofacitinib 5mg will be given once daily for 2 weeks. Blood investigations (CBC, LFT and KFT) will be repeated at the end of 2 weeks and dose will be escalated to 5 mg twice daily and this will be continued till 4 months or till complete regrowth of hair occurs or whichever is earlier. 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Clinically diagnosed patient of alopecia areata with more than 20% scalp hair loss or rapidly
progressive disease.
2. Age >14 years and <50 years 
 
ExclusionCriteria 
Details  1. Previously treated patients within 2 weeks of topical therapy or 4 weeks of systemic therapy
2. Patients who have hepatic impairment
3. Patients with abnormal blood counts (lymphocyte <500cell/mm3 or neutrophils <1000
cell/mm3)
4. Pregnant and lactating women.
5. Immunocompromised patients or if is a K/C/O Hepatitis B,C,or HIV
6. Patient having an active infection, any systemic illness, uncontrolled diabetes mellitus or
hypertension. 
 
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 
Change in SALT Score.   At 4 weeks, 8 weeks, 12 weeks and 16 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Physician global assessment score
2. Patient global assessment score
3. Dermatology Life Quality Index
4. Side effects 		 At 4 weeks, 8 weeks, 12 weeks and 16 weeks. 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="94" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/12/2022 
Date of Study Completion (India) 20/03/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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 (AA) is an autoimmune disorder which usually presents as non-scarring patches of hair loss.  AA comprises nearly one-fourth of all cases of hair loss. It usually starts in childhood but can affect individuals of any age. Unfortunately, there is no cure and no universally proven treatment that induces sustained remission for AA. Various treatment modalities used in alopecia areata are corticosteroids, immunotherapy and PUVA. Out of these, corticosteroids seem to be the most common treatment, however, the use of corticosteroids is associated with many adverse effects. In addition to the adverse effects, the response rate to the steroids varies greatly among patients. Several studies indicate that inhibition of the JAK pathway could be a promising treatment option for severe or progressive alopecia areata. Various retrospective studies and case series show a very promising response of Tofacitinib in the treatment of AA. However, a very few prospective studies have been conducted to compare the efficacy of tofacitinib with conventional treatment used in AA. In this study we will compare the efficacy of tofacitinib versus oral steroid in the management of alopecia areata.
 
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