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CTRI Number  CTRI/2025/06/089419 [Registered on: 24/06/2025] Trial Registered Prospectively
Last Modified On: 23/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Intralesional steroids versus 2 percent tofacitinib ointment for alopecia areata 
Scientific Title of Study   Efficacy of intralesional steroids versus 2 percent tofacitinib ointment for treatment of patchy alopecia areata among patients attending dermatology clinic in a teaching tertiary care hospital: A randomized control trial 
Trial Acronym  ILS VS 2 percent Tofacitinib ointment 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manobalan K 
Designation  Associate Professor 
Affiliation  Sri Venkateshwaraa medical college hospital 
Address  Sri Venkateshwaraa medical college hospital ariyur Puducherry, Department of D.V.L Room no.- 110

Pondicherry
PONDICHERRY
605102
India 
Phone  9488351988  
Fax    
Email  manobalankaruna@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manobalan K 
Designation  Associate Professor 
Affiliation  Sri Venkateshwaraa medical college hospital 
Address  Sri Venkateshwaraa medical college hospital ariyur Puducherry Department of D.V.L Room no.- 110


PONDICHERRY
605102
India 
Phone  9488351988  
Fax    
Email  manobalankaruna@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manobalan K 
Designation  Associate Professor 
Affiliation  Sri Venkateshwaraa medical college hospital 
Address  Sri Venkateshwaraa medical college hospital ariyur Puducherry Department of D.V.L Room no.- 110


PONDICHERRY
605102
India 
Phone  9488351988  
Fax    
Email  manobalankaruna@gmail.com  
 
Source of Monetary or Material Support  
Sri Venkateshwaraa medical college hospital, Puducherry - 605 102, INDIA 
 
Primary Sponsor  
Name  Dr Manobalan 
Address  Sri venkateshwaraa medical college and hospital, Ariyur, Puucherry, Puducherry - 605 102, INDIA 
Type of Sponsor  Private 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 Manobalan K  Sri venkateshwaraa medical college  Sri Venkateshwaraa medical college hospital ariyur Puducherry Department of D.V.L Room no.- 110
Pondicherry
PONDICHERRY 		 09488351988

manobalankaruna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Venkateshwaraa Medical College (Institutional Ethics Committee)  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  2% Tofacitinib ointment  Patients will apply 2% tofacitinib ointment twice daily applied (1 Fingertip unit = 0.5g) over affected areas of the scalp for 12 weeks. 
Intervention  Intralesional steroids  Patients will receive intralesional injections of triamcinolone acetonide along the border of patch (10 mg/mL – scalp; 5mg/mL - face), injected (0.2 to 0.3ml per inch) at 3-week intervals for a total of 12 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Adult patients presenting with patch type alopecia areata involving scalp or face.
2. No prior treatment with corticosteroids, JAK inhibitors, or immunosuppressive agents within the last six months.
 
 
ExclusionCriteria 
Details  1. Patients below 18 years of age.
2. Extensive alopecia areata (sisaipho, ophiasis, reticular, alopecia sub-totalis, alopecia totalis, alopecia universalis)
3. Scarring alopecia
4. Patients with a known allergy to corticosteroids or tofacitinib.
5. Pregnant or lactating women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
change in severity of alopecia areata tool (SALT) score from baseline to week 12.  baseline to week 12 
 
Secondary Outcome  
Outcome  TimePoints 
trichoscopic parameters, such as number of yellow dots, black dots ana vellus hair measured from baseline to week 12.
adverse events including local reactions, skin atrophy, erythema, any systemic side effects. 		 baseline to week 12 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   04/07/2025 
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="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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [manobalankaruna@gmail.com].

  6. For how long will this data be available start date provided 10-08-2025 and end date provided 01-01-0001?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Alopecia areata is a chronic, non-scarring, auto-immune condition affecting the hair bulb thereby resulting in hair loss. The life-time risk of AA is about 2.1% in both children and adults. It can present as single, well demarcated patch of hair losss, multiple patches or extensive hair loss (alopecia totalis and alopecia universalis). Treatment response in high in patchy type than extensive type. For patchy type intralesional corticosteroid remains the main stay of treatment with complete regrowth of hair. Newer treatment with JAK-STAT inhibitors is becoming a trend with unpredictable results. Though there are literature for interalesional steroids in alopecia areata, only paucity of studies in topical tofacitinib for alopecia areata. In our study we will compare the outcomes of intralesional steroids and topical tofacitinib in cases of patch type alopecia areata.

 
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