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CTRI Number  CTRI/2024/07/071507 [Registered on: 29/07/2024] Trial Registered Prospectively
Last Modified On: 25/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Intralesional steroid, Excimer laser]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A prospective clinical study to compare efficacy and safety of 308 nm excimer laser and intralesional steroid injection for treatment of alopecia areata 
Scientific Title of Study   Effectiveness and safety of 308 nm excimer laser versus intralesional triamcinolone acetonide for the treatment of alopecia areata; A randomized control trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Allam Priyanka Reddy 
Designation  Post graduate  
Affiliation  SRM Medical College and Research Centre  
Address  C- 15, Department of Dermatology, Venereology and Leprosy, second floor, SRM Medical College and Research Centre, Kattankulathur, Potheri, Tamil Nadu-603203

Kancheepuram
TAMIL NADU
603203
India 
Phone  9686596176  
Fax    
Email  shashipriyanka999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Murali Narasimhan 
Designation  HOD and Professor  
Affiliation  SRM Medical College Hospital and Research Centre  
Address  C- 15, Department of Dermatology, Venereology and Leprosy, second floor, SRM Medical College Hospital and Research Centre, Kattankulathur, Potheri, Tamil Nadu-603203

Kancheepuram
TAMIL NADU
603203
India 
Phone  9840168711  
Fax    
Email  leecutis@gmail.com  
 
Details of Contact Person
Public Query  
Name  Allam Priyanka Reddy 
Designation  Post graduate  
Affiliation  SRM Medical College and Research Centre  
Address  C- 15, Department of Dermatology, Venereology and Leprosy, second floor, SRM Medical College and Research Centre, Kattankulathur, Potheri, Tamil Nadu-603203

Kancheepuram
TAMIL NADU
603203
India 
Phone  9686596176  
Fax    
Email  shashipriyanka999@gmail.com  
 
Source of Monetary or Material Support  
SRM Medical College and Research Centre, kattankulathur, Tamil Nadu-603203 
 
Primary Sponsor  
Name  SRM Medical College Hospital and Research Centre 
Address  C-15 Department of Dermatology, Potheri, kattankulathur, Tamil Nadu-603203 
Type of Sponsor  Research institution and hospital 
 
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 Allam Priyanka Reddy  SRM Medical College Hospital and Research Centre  C-15, Department of Dermatology, Venereology and Leprosy, kattankulathur, Tamil Nadu-603203
Kancheepuram
TAMIL NADU 		 9686596176

shashipriyanka999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital Institutional Ethics Committee- Students  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  308 nm Excimer laser  308 nm Excimer laser given twice a week for 12 weeks which is 24 sittings and follow up is at week 16. The total duration of study is 4 months 
Intervention  Intralesional steroid -triamcinolone acetonide(5mg /ml)  Intralesional steroid ( triamcinolone acetonide 5 mg/ml ) given intradermally in small volumes of 0.1 ml once in 4 weeks on week 0, 4, 8, 12 and follow-up at week 16. The total duration of the study is 4 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. All patients of 18 years of age and above attending SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER dermatology OPD, diagnosed with alopecia areata.
2. Patients having 1-5 patches on the scalp.
3. Patients who have not received any hair related treatment in the past 3 months
4. Patients providing voluntary informed and written consent for the explained treatment modality to be performed.
 
 
ExclusionCriteria 
Details  1. Other types of AA such as ophiasis, sisapho, totalis , universalis
2. Patients with single alopecic patch greater than 6x6 sq.cm
Total area of all patches combined should not exceed 80 sq.cm
3. Pregnancy or breastfeeding
4. Infection
5. Other immunological disorders and endocrine diseases which causes hair loss
6. Photosensitive skin
7. Patients unwilling to continue cooperation in the trial
8. Progressive AA during the trial
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Extent and density of regrowth by the SALT scoring system  Week 0, 4 ,8 ,12 , 16 20 and 24 
 
Secondary Outcome  
Outcome  TimePoints 
Visual Analogue Scale  Week 0, 4 ,8 ,12 , 16, 20 and 24 
Global Aesthetic Improvement Scale,
Patient satisfaction score 		 Week 24 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   12/08/2024 
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="0"
Months="6"
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 - 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 -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shashipriyanka999@gmail.com].

  6. For how long will this data be available start date provided 26-06-2024 and end date provided 15-01-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
Proceedure:
Patients  will be randomised in two groups A and B
  1. Group A : ILS ( triamcinolone acetonide 5 mg/ml ) given once in 4 weeks.
  2. Group B : 308 nm Excimer laser given twice a week

Group A 
  • ILS ( triamcinolone acetonide 5 mg/ml ) given once in 4 weeks
  • Initial visit - evaluation and inclusion into study
  • Scalp will be adequately cleansed and degreased
  • It is injected intradermal as 0.1 ml per sq.cm of involved skin
  • Patients will be coming to the clinic at 4 weeks as per the schedule for subsequent injections at week 0,4,8 and 12 and follow up at week 16,20 and 24.
  • Follow up photographs taken at week 0,4,8,12,16,20 and 24.
  •  Patient will be excluded from the study if he/ she delays for > 2 weeks
Group B
  • 308 nm Excimer laser given twice a week
  • Initial visit – evaluation, inclusion into study and  determination  of minimal erythema dose 
  • Following visit, treatment is started at a sub MED dose 
  • Subsequent irradiation dose  is increased  by 100 J/cm2 in next session till the endpoint is reached, which is 24 sittings or complete hair regrowth, whichever is earlier.
Assessment of hair regrowth 
This takes into account extent and density of regrowth by the SALT scoring system. First note percent regrowth, then further categorise by: 
  • A0 = no change or further loss 
  • A1 = 1-24% regrowth 
  • A2 = 25-49% regrowth 
  • A3 = 50-74% regrowth 
  • A4 = 75-99% regrowth
  • A5 = 100 % regrowth
 
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