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CTRI Number  CTRI/2024/07/070467 [Registered on: 11/07/2024] Trial Registered Prospectively
Last Modified On: 11/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the Effectiveness of Triamcinolone Acetonide and Vitamin D3 Injections in Treating Spot baldness 
Scientific Title of Study   A Comparative Study To Evaluate The Efficacy Of Intralesional Injections Of Triamcinolone Acetonide Versus Vitamin D3 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  Medha Mishra 
Designation  Junior Resident 
Affiliation  Eras Lucknow Medical College and Hospital 
Address  Department of Pharmacology 5th floor Eras Lucknow Medical College and Hospital Sarfarzganj Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  7897023333  
Fax    
Email  mishramedha1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Afroz Abidi 
Designation  Professor 
Affiliation  Eras Lucknow Medical College and Hospital 
Address  Department of Pharmacology 5th floor Eras Lucknow Medical College and Hospital Sarfarzganj Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  7275543349  
Fax    
Email  afrozabidi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Medha Mishra 
Designation  Junior resident 
Affiliation  Eras Lucknow Medical College and Hospital 
Address  Department of Pharmacology 5th Floor Eras Lucknow Medical College and Hospital Sarfarzganj Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  7897023333  
Fax    
Email  mishramedha1@gmail.com  
 
Source of Monetary or Material Support  
Eras Lucknow Medical College and Hospital Sarfarzganj Lucknow Uttar Pradesh 226003 India 
 
Primary Sponsor  
Name  Medha Mishra 
Address  Department of Pharmacology 5th Floor Eras Lucknow Medical College and Hospital Sarfarzganj Lucknow Uttar Pradesh 226003 India 
Type of Sponsor  Other [Self] 
 
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 Medha Mishra  Eras Lucknow Medical College and Hospital  Department of Pharmacology 5th Floor
Lucknow
UTTAR PRADESH 		 7897023333

mishramedha1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ELMCH,Era University,Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L63||Alopecia areata,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  TRIAMCINOLONE ACETONIDE  Dose 10 mg/ml Route Intralesional Frequency Single dose only every 3 weeks Duration 12 weeks 
Comparator Agent  VITAMIN D3  Dose 1ml of 100000 IU Route Intralesional Frequency Single dose only every 3 weeks Duration 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Non-scarring, patchy hair loss over the scalp.
Patients who have not received any treatment for Alopecia areata in past 4 weeks. 
 
ExclusionCriteria 
Details  1. Individuals under 18 years of age.
2. Women who are pregnant and lactating.
3. Patients with local site skin infection.
4. Patients on Immunosuppresants.
5. Patients with underlying malignancies.
6. Patients taking Vitamin D supplements in last 6 months.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement of SALT Scoring and Digital Photography.  3rd week 6th week 9th week and 12th week
 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse drug reaction  3, 6, 9 and 12th week 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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 4 
Date of First Enrollment (India)   01/08/2024 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mishramedha1@gmail.com].

  6. For how long will this data be available start date provided 01-08-2024 and end date provided 29-03-2026?
    Response - Immediately following publication. No end date.

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

TITLE - A Comparative study to evaluate the efficacy of Intralesional injections of Triamcinolone acetonide versus Vitamin D3 in the treatment of Alopecia areata
BACKGROUND- 
Alopecia areata is an autoimmune condition .Immune system mistakenly attacks hair follicles that leads to patches of non scarring hair loss. Exact cause of alopecia areata is not known and believed to involve a combination of genetic, environmental, and immunological factors.  Intralesional Cortiocosteroid affect local cytokine expression leading to gradual decrease in type 1 and 2 cytokines in parallel with clinical improvement suggesting direct suppression of local immune response. Vitamin D receptors (VDRs) highly expressed in keratinocytes of human hair follicles and absence of expression of VDRs associated with reduced hair follicle growth and epidermal differentiation.
MATERIAL AND METHODS - The study was a prospective, randomized, open-labeled investigation conducted over 18 months. It took place at the Department of Pharmacology, in collaboration with the Department of Dermatology, at Era’s Lucknow Medical College and Hospital in Lucknow. The research focused on patients presenting to the Dermatology outpatient department with a clinical diagnosis of alopecia areata. The sample size consisted of 72 patients, divided equally into two groups of 36 each.
 
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