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CTRI Number  CTRI/2024/02/062980 [Registered on: 21/02/2024] Trial Registered Prospectively
Last Modified On: 21/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment of Alopecia Areata  
Scientific Title of Study   A randomized clinical trial evaluating the efficacy and safety of Jesners solution against 88% Phenol: 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 Rakesh Tilak Raj 
Designation  Assistant Professor  
Affiliation  Government Medical College 
Address  Skin department Government Medical College Amritsar
NA
Amritsar
PUNJAB
143001
India 
Phone  9653727009  
Fax    
Email  rakeshtraj2012@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tejinder Kaur 
Designation  Professor & Head 
Affiliation  Government Medical college  
Address  Skin department Government Medical College Amritsar
NA
Amritsar
PUNJAB
143001
India 
Phone  9815514499  
Fax    
Email  tejinderkaur@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sahib Preet kaur 
Designation  senior resident 
Affiliation  Government Medical college 
Address  Skin department Government Medical College Amritsar
NA
Amritsar
PUNJAB
143001
India 
Phone  7888783730  
Fax    
Email  gurcharanrajwant@gamil.com  
 
Source of Monetary or Material Support  
Government Medical College, circular road, Amritsar, Punjab. pin code-143001.  
 
Primary Sponsor  
Name  Dr Rakesh Tilak raj 
Address  Skin department Government Medical College Amritsar  
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 Rakesh Tilak Raj  Government Medical College Amritsar  Hair clinic, Room No 21, Second floor Department of skin
Amritsar
PUNJAB 		 9653727009

rakeshtraj2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Government Medical college Amritsar  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  88% phenol solution (88ml liquefied pure phenol in 100 ml of water)  1.The area to be treated will be degreased by scrubbing with savlon, followed by spirit and acetone. 2.In a small glass container 0.5 ml to1ml will be taken. 3.With the help of cotton tipped applicator it will be applied to the affected area by giving gentle strokes until ivory white uniform frosting will be seen. 4.Feathering of the borders will be done by painting of the phenol from the periphery of the lesion into the surrounding normal skin. 5.No neutralization of the phenol will be done in any of the patients 6.All patients will be monitored for half an hour for pulse and heart rate after the procedure. 7.Three applications (with a gap of 15 minutes) of 88% phenol will be done at three weekly intervals for each patient  
Intervention  Jessner’s solution (salicyclic acid+ lactic acid+ Resorcinol 14% each) provided in containers according to the manufactures   1.The patch to be treated will be wiped with alcohol and acetone. 2.Following degreasing, Jessner’s solution (salicyclic acid+ lactic acid+ Resorcinol 14% each) provided in containers according to the manufactures will be applied on the patch covering the full size of the patch. 3.one-three coats of the solution will be applied till the end point being uniform areas of erythema with slight frosting appears 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.who has not received any treatment during previous 2 months before commencing of the study.
2.Patients with minimum of two patches; ranging in circumference between 3cm to 10 cm.
3.Patients with patchy patches of stable AA over the scalp
4.Patients willing to be part of the study after informed consent. 
 
ExclusionCriteria 
Details  1.Patients treated with any other topical agent or immunosuppressive drugs.
2.Patients with scarring alopecia and scalp condition affecting the outcomes.
3.Patients who were on any allopathic or homeopathic treatment.
4.Patients with psychiatric medications and unrealistic expectations.
5.Pregnant and lactating mothers.
6.Patients with a history of keloid and hypertrophic scars.
7.Patient with any systemic disease (Cardiac, Renal, Hepatic, HIV, etc).
8.Patient with history of drug abuse.
9.Patient with collagen vascular disorder and auto-immune.
10.Patients with alopecia totalis and universalis.
11.Unwilling patients.
12.Other causes of alopecia like Androgenic alopecia, Diffuse telogen effluvium




 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To assess the safety and therapeutic efficacy of 12 weeks regimen of administration of investigational products in adult Alopecia areata
2.Treatment frequency  		 Baseline,4 weeks,8weeks and 12weeks  
 
Secondary Outcome  
Outcome  TimePoints 
1. Assessment of hair growth from baseline using digital photography and Dermoscopy or Trichoscopy.
2.Time for regrowth
3.Sustainability of hair growth response over a 12 weeks post treatment period of observation.
4. Hair regrowth outcome assessment using SALT scoring.  		 Post treatment observation follow up at
1. 16 weeks
2. 20 weeks
3. 24 weeks. 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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 3 
Date of First Enrollment (India)   05/03/2024 
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)  Open to Recruitment 
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  

Alopecia areata is common dermatological condition causing non-scarring hair loss affecting the quality of life and self-esteem. The treatment of alopecia areata remains challenging. Various modalities of treatment are available and most of the therapies used for the treatment of alopecia areata causes variety of side effect. Thus, quest for safer methods of treatment continues. Till date, there is no universally accepted therapy for the treatment of alopecia areata. Success of peeling agents like Phenol and Jessner’s solution helps in inducing hair growth in alopecia areata subjects that can be explained on the basis of release of growth factors and cytokines that are capable of antagonizing the peribulbar inflammatory infiltrate. Another proposed mechanism is through immunodulation causing destruction of hyperactive T cells mediated by local sensitizers. The present study is proposed to evaluate the efficacy and safety of Jessener solution against 88% phenol in the treatment of Alopecia Areata.

 

 

 
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