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CTRI Number  CTRI/2022/11/047692 [Registered on: 25/11/2022] Trial Registered Prospectively
Last Modified On: 24/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison study of effect of two concentrations of intra-lesional injection of a drug in patchy hair loss of the scalp 
Scientific Title of Study   Comparison of therapeutic efficacy and safety of two concentrations of intra-lesional triamcinolone acetonide in patchy alopecia areata of the scalp: an open label randomized trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhavnish Bansal 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, Bathinda 
Address  Dermatology Department First Floor B Block, AIIMS Bathinda

Bathinda
PUNJAB
151001
India 
Phone  9041944944  
Fax    
Email  bansalbhavnish@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shivani Bansal 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Bathinda 
Address  Dermatology Department First Floor B Block, AIIMS Bathinda

Bathinda
PUNJAB
151001
India 
Phone  8287020404  
Fax    
Email  drshivani.derm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhavnish Bansal 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, Bathinda 
Address  Dermatology Department First Floor B Block, AIIMS Bathinda

Bathinda
PUNJAB
151001
India 
Phone  9041944944  
Fax    
Email  bansalbhavnish@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bathinda 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
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 Bhavnish Bansal  All India Institute of Medical Sciences,Bathinda  Department of Dermatology, room no. 2104, first floor, B Block, OPD AIIMS, Dabwali Road, Jodhpur Romana, Bathinda
Bathinda
PUNJAB 		 9041944944

bansalbhavnish@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  Intralesional triamcinolone acetonide injection 10mg/ml  Intra-lesional injection of triamcinolone acetonide in patch of alopecia areata (10mg/ml); under aseptic conditions, using a 0.5 inch long, 30 gauge needle, fitted to an insulin syringe, a session every 3 weeks for 4 sessions or until complete hair re-growth whichever is earlier. 0.1 ml will be injected at a gap of about 1cm2 intra-dermally not exceeding 20 mg in one session. 
Intervention  Intralesional Triamcinolone Acetonide injection 5 mg/ml   Intra-lesional injection of triamcinolone acetonide in patch of alopecia areata (10mg/ml); under aseptic conditions, using a 0.5 inch long, 30 gauge needle, fitted to an insulin syringe, a session every 3 weeks for 4 sessions or until complete hair re-growth whichever is earlier. The steroid will be prepared in 1ml insulin syringe by adding 0.5 ml saline to 0.5 ml of the steroid to reach a concentration of 5 mg/ml, then 0.1 ml will be injected at a gap of about 1cm2 intra-dermally not exceeding 20 mg in one session.  
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients of both sexes(males and females), aged >13 years with AA,
2. Patients having AA on the scalp with <50% involvement.
3. Patients who had not taken any form of treatment in the last 8 weeks.
4. Patients who are willing to sign the written consent form before participating in the study
 
 
ExclusionCriteria 
Details  1. Patients aged <13 years
2. Patients with alopecia totalis, alopecia universalis and ophiasis.
3. Patients having skin diseases affecting the scalp.
4. Patients with active infection at the local site and with keloidal tendency.
5. Pregnant or lactating women or immuno-compromised patients or patients with bleeding or coagulation disorders
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in Severity Alopecia Tool (SALT) Score, 5 point semi-quantitative Re Growth Scale (RGS) and Dermoscopic Assessment  At Baseline,3 weeks, 6 weeks, 9 weeks,12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Assess side effects with two concentrations of intra-lesional injection of triamcinolone acetonide  Every 3 weeks then at the 3 months of therapy from baseline (3weeks after the 4th session)  
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   01/12/2022 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

1.      A detailed history will be obtained from each patient after taking the written informed consent to document the  age and sex of the patients, the presence of a positive family history (in a first–degree relative), as well as the  duration and course of the disease

2.      Clinical Examination will be done to detect associations (nail changes and any other autoimmune diseases) and to determine the type and extent of AA, which will be assessed using the Severity of Alopecia Tool (SALT) score (Annexure-II)

3.      A baseline digital camera photograph of the patch and dermoscopic parameters will be done on one representative patch of hair loss on the scalp between 12 o’clock and 3 o’clock position in clockwise direction of investigator

4.      Patient’s Proforma will be filled for all the patients included in the study.

5.      Patients will be randomly divided into 2 groups:

Group A: Intralesional injection of triamcinolone acetonide 5mg/ml will be given for 4 sessions every 3 weekly or until complete hair re-growth whichever is earlier

Group B: Intralesional injection of triamcinolone acetonide 10mg/ml will be given for 4 sessions every 3 weekly or until complete hair re-growth whichever is earlier

6.      Monitoring of treatment response and side effects will be done in both groups every 3 weeks then at the 3 months of therapy from baseline (3 weeks after the 4th session) by an investigator through a clinical examination using Reduction in SALT Score and Re-Growth Scale (RGS), photography and dermoscopic examination with photography (dermoscopic readings will be taken in a quadrant lying between the 12 O′ clocks and at 3 O′ clock position in a clockwise direction). Side effects like pain, and epidermal and dermal atrophy will be assessed in both groups at every visit.

 
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