FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/04/084602 [Registered on: 11/04/2025] Trial Registered Prospectively
Last Modified On: 06/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Role of topical tofacitinib in alopecia (hair loss). 
Scientific Title of Study   A comparative randomised controlled trial evaluating the efficacy of topical tofacitinib versus topical clobetasol propionate in localised alopecia areata.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sukarna Saha 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Science, Jodhpur 
Address  Room no.-105, Dermatology OPD, AIIMS Jodhpur, Basni, Jodhpur, Rajasthan, India

Jodhpur
RAJASTHAN
342005
India 
Phone  9954129813  
Fax    
Email  sukarnasaha17425@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anupama Bains  
Designation  ASSOCIATE PROFESSOR 
Affiliation  All India Institute of Medical Science, Jodhpur 
Address  Room no.-105, Dermatology OPD, AIIMS Jodhpur, Basni, Jodhpur, Rajasthan, India

Jodhpur
RAJASTHAN
342005
India 
Phone  7297895727  
Fax    
Email  doc.trinity@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Sukarna Saha 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Science, Jodhpur 
Address  Room no.-105, Dermatology OPD, AIIMS Jodhpur, Basni, Jodhpur, Rajasthan, India

Jodhpur
RAJASTHAN
342005
India 
Phone  9954129813  
Fax    
Email  sukarnasaha17425@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Jodhpur, Basni, Jodhpur, Rajasthan, India, 342005 
 
Primary Sponsor  
Name  AIIMS Jodhpur 
Address  AIIMS Jodhpur, Basni, Jodhpur, Rajasthan, India, 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 Sukarna Saha  AIIMS Jodhpur  Room no.-105, Dermatology OPD, AIIMS Jodhpur, Basni, Jodhpur, Rajasthan, India
Jodhpur
RAJASTHAN 
09954129813

sukarnasaha17425@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L638||Other alopecia areata,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Efficacy of topical clobetasol propionate in localized alopecia areata.  Patients with localized alopecia areata over scalp with SALT score S1, more than 5 years, having stable disease.Research question is whether topical tofacitinib is better than topical clobetasol propionate.Aim of study is to compare efficacy of topical tofacitinib versus topical clobetasol propionate in localized alopecia areata.Primary objective is to compare efficacy of topical tofacitinib versus topical clobetasol propionate in localised alopecia areata by Hair Regrowth Score.Secondary objective is to compare no. of patients having 50% improvement in RGS, percentage reduction in area involved with alopecia areata in both groups, quality of life of patients using DLQI, to compare side effects profile in both groups and to assess relapse.Patients will be given topical tofacitinib 2 percent ointment twice daily and topical clobetasol propionate 0.05 percent ointment twice daily to patients with age group more than 12 years and in age group 6-12 years,clobetasol is given twice a day for 4 weeks then once a day for 4 weeks then on alternate days for 4 weeks and twice a week for 4 weeks.Total duration of treatment is 4 months.Expected outcome will be assessed by clinical picture, trichoscopy, RGS, SALT at baseline and every visit.Study duration will be approximately 18 months. 
Intervention  Efficacy of topical tofacitinib versus in localized alopecia areata.  Patients with localized alopecia areata over scalp with SALT score S1, more than 5 years, having stable disease.Research question is whether topical tofacitinib is better than topical clobetasol propionate.Aim of study is to compare efficacy of topical tofacitinib versus topical clobetasol propionate in localized alopecia areata.Primary objective is to compare efficacy of topical tofacitinib versus topical clobetasol propionate in localised alopecia areata by Hair Regrowth Score.Secondary objective is to compare no. of patients having 50% improvement in RGS, percentage reduction in area involved with alopecia areata in both groups, quality of life of patients using DLQI, to compare side effects profile in both groups and to assess relapse.Patients will be given topical tofacitinib 2 percent ointment twice daily and topical clobetasol propionate 0.05 percent ointment twice daily to patients with age group more than 12 years and in age group 6-12 years,clobetasol is given twice a day for 4 weeks then once a day for 4 weeks then on alternate days for 4 weeks and twice a week for 4 weeks.Total duration of treatment is 4 months.Expected outcome will be assessed by clinical picture, trichoscopy, RGS, SALT at baseline and every visit.Study duration will be approximately 18 months. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients who are clinically diagnosed with
localized alopecia areata over scalp.
2. SALT score S1(less than 25 percent hair loss).
3. Age group more than 5 years.
4. Stable disease without appearance of new patch or increase in size of existing patch in last 15 days and without evidence of spontaneous hair regrowth.  
 
ExclusionCriteria 
Details  1. Pregnant and lactating females.
2. Patients who have received any topical treatment within the last 2 weeks or systemic corticosteroids, immunosuppressants, or oral tofacitinib in the past month.
3. Patch with atrophy or active infection at the site of patch.
4. Alopecia totalis, alopecia universalis, ophiasis, sisaipho pattern and alopecia areata involving sites other than scalp.
5. Patients with history of HIV, Hep B, Hep C, TB, leucopenia, hepatic and renal impairment.

 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Hair regrowth score (RGS) at end of 4 months.  Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.Number of patients having more than 50% improvement in RGS score.

2. Percentage reduction in area involved with alopecia areata in both the groups.
3. Change in SALT score
4. DIMT classification for patterns of regrowth
5. Patient satisfaction score
6. Improvement in trichoscopy parameters
7Quality of life of patients using Dermatology Life Quality Index (DLQI)
8.Side effects in both groups.
9.To assess relapse (if any) in both the groups.
 
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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 3 
Date of First Enrollment (India)   21/04/2025 
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="10"
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  

The study will be conducted amongst patients of localised alopecia areata attending Dermatology, Venereology and Leprology department, AIIMS Jodhpur. The study will be including patients who are clinically diagnosed with localised alopecia areata over scalp with SALT score S1(<25% hair loss) with age group >5 years, having stable disease without appearance of new patch or increase in size of existing patch in last 15 days and without evidence of spontaneous hair regrowth. Patients who are pregnant, lactating, who had received any topical in last 2 weeks or systemic corticosteroid, immunosuppressant or oral tofacitinib in past 4 weeks, Alopecia totalis, alopecia universalis, ophiasis, sisaipho and alopecia with sites other than scalp, history of HIV, Hepatitis C, Hepatitis B, Tuberculosis, hepatic and renal impairment will be excluded from the study. The research question is whether topical tofacitinib is better than topical clobetasol propionate in patients of alopecia areata in terms of efficacy. The aim of the study is to compare the efficacy of topical tofacitinib versus topical clobetasol propionate in localised alopecia areata. The primary objective is to compare the efficacy of topical tofacitinib versus topical clobetasol propionate in localised alopecia areata in terms of Hair Regrowth Score (RGS). The secondary objective is to compare the no. of patients having >50% improvement in RGS, % reduction in area involved with alopecia areata in both groups, quality of life of patients using DLQI, to compare the side effects profile in both the groups and to assess relapse (if any) in both the groups. Patients will be given topical tofacitinib 2% ointment twice daily and topical clobetasol propionate 0.05% ointment is given twice daily to patients with age group more than 12 years and in age group 6-12 years, clobetasol is given twice a day for 4 weeks then once a day for 4 weeks then on alternate days for 4 weeks and twice a week for 4 weeks. The total duration of treatment is 4 months. At every visit, expected outcome will be assessed by clinical picture, trichoscopy, RGS, SALT at baseline and every visit. The study duration will be approximately 18 months.

 
Close