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CTRI Number  CTRI/2024/12/078575 [Registered on: 24/12/2024] Trial Registered Prospectively
Last Modified On: 24/12/2024
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to compare 2 percent tofacitinib cream and calcipotriol 0.005 percent ointment in patchy hair loss over scalp 
Scientific Title of Study   A comparative study on clinical efficacy of Topical Tofacitinib 2 percent cream versus Topical Calcipotriol 0.005 percent ointment in the treatment of 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  DR NEHA KHAN 
Designation  JUNIOR RESIDENT 
Affiliation  ERA S LUCKNOW MEDICAL COLLEGE AND HOSPITAL 
Address  Department of dermatology Era’s Lucknow Medical College and Hospital Sarfarazganj Lucknow, Uttar pradesh Lucknow UTTAR PRADESH 226003 India
Department of dermatology Era’s Lucknow Medical College and Hospital Sarfarazganj Lucknow, Uttar pradesh Lucknow UTTAR PRADESH 226003 India
Lucknow
UTTAR PRADESH
226003
India 
Phone  9599915229  
Fax    
Email  kneha8302@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR KSHITIJ SAXENA 
Designation  Professor 
Affiliation  Era’s Lucknow Medical College and Hospital 
Address  Department of dermatology Era’s Lucknow Medical College and Hospital Sarfarazganj Lucknow, Uttar pradesh Lucknow UTTAR PRADESH 226003 India

Lucknow
UTTAR PRADESH
226003
India 
Phone  9208015391  
Fax    
Email  drkshitijsaxena@live.com  
 
Details of Contact Person
Public Query  
Name  DR NEHA KHAN 
Designation  Junior resident 
Affiliation  ERA S LUCKNOW MEDICAL COLLEGE AND HOSPITAL 
Address  Department of dermatology Era’s Lucknow Medical College and Hospital Sarfarazganj Lucknow, Uttar pradesh Lucknow UTTAR PRADESH 226003 India
Department of dermatology Era’s Lucknow Medical College and Hospital Sarfarazganj Lucknow, Uttar pradesh Lucknow UTTAR PRADESH 226003 India
Lucknow
UTTAR PRADESH
226003
India 
Phone  859574206  
Fax    
Email  Kneha8302@gmail.com  
 
Source of Monetary or Material Support  
Era s lucknow medical college and hospital Sarfarazganj Lucknow, Uttar Pradesh 226003 India 
 
Primary Sponsor  
Name  ERAS LUCKNOW MEDICAL COLLEGE AND HOSPITAL 
Address  Department of dermatology Era s lucknow medical college and hospital Sarfarazganj Lucknow, Uttar pradesh, 22600 
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 NEHA KHAN  Era Lucknow medical college and hospital Lucknow   Department of dermatology Room No.2 Era s lucknow medical college and hospital Sarfarazganj Lucknow, Uttar Pradesh 226003 Lucknow UTTAR PRADESH
Lucknow
UTTAR PRADESH 		 9599915229

kneha8302@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  CALCIPOTRIOL 0.005% OINTMENT  Calcipotriol Dose-0.005% Frequency-Twice Daily Route- Topical application over the affected area Follow up- 4weeks, 8weeks,12weeks, 16weeks Duration of study- 16 weeks after completion of trial period, treatment of patient with the drug shall continue if necessary. 
Intervention  TOFACITINIB 2% CREAM  Tofacitinib Dose-2% Frequency-Twice Daily Route- Topical application over the affected area Follow up- 4weeks, 8weeks,12weeks, 16weeks Duration of study- 16weeks after completion of trial period, treatment of patient with the drug shall continue if necessary. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  All consenting patients of alopecia areata with SALT score less than 25% scalp involvement of either gender aged 18 years and above visiting in Dermatology OPD
 
 
ExclusionCriteria 
Details  Patients who have taken any form of treatment in past 3 months

Immunocompromised patients or patients on immunosuppressive therapy will be excluded

Pregnant or lactating mothers

Patient with a history of hypersensitivity to tofacitinib or calcipotriol
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the efficacy of topical tofacitinib cream (2%) and topical calcipotriol ointment (0.005%) in promoting hair regrowth and minimizing disease progression in individuals with alopecia areata  4 weeks,8 weeks,12 weeks, 16 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To analyse the efficacy of tofacitinib cream (2%) in alopecia areata.

To analyse the efficacy of calcipotriol ointment (0.005%) in alopecia areata.

To analyse potential side effects & patient’s tolerability associated with the use of topical tofacitinib cream (2%) & topical calcipotriol ointment (0.005%). 		 4 weeks,8weeks,12weeks,16weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   12/01/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

A total of 100 patients of alopecia areata visiting dermatology OPD of Era’s Lucknow Medical College and Hospital fulfilling inclusion will be enrolled in our study.

 

•Written informed consent will be taken from patients prior to participation in study.

 

•Patients will be randomly divided into two groups - group A and group B each containing 50 individuals.

 

•Detailed history and clinical examination12of the scalp with photographic documentation and subjective response will be noted before the start of the treatment and then at each visit (4,8,12 and 16 weeks) and results will be tabulated in respective tables.


1.In group A – 

 

Each patient will be advised tofacitinib cream (2%) twice daily application over the affected area for 12 weeks with follow up at every 4th, 8th, 12th and 16th week.

 

2. In group B-

Each patient will be advised calcipotriol ointment (0.005%) twice daily application over the affected area for 12 weeks with follow up at every 4th, 8th, 12th and 16th week .


 
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