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CTRI Number  CTRI/2022/10/046885 [Registered on: 28/10/2022] Trial Registered Prospectively
Last Modified On: 28/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing once daily versus an itch based multiple times Ddaily application of a superpotent steroid cream in lichen simplex chronicus 
Scientific Title of Study   A randomised controlled trial comparing once daily versus itch-based multiple daily application of clobetasol propionate 0.05% cream in lichen simplex chronicus 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sree Parvathy V 
Designation  Junior resident 
Affiliation  All India Institute of Medical Sciences 
Address  Skin OPD,Room 309,3rd floor,New Rajkumari Amrit Kaur OPD,All India Institute of Medical Sciences,New Delh,110029,India
Sri Aurobindo Marg,Ansari Nagar,Ansari Nagar East,New Delhi,Delhi 110029
New Delhi
DELHI
110029
India 
Phone  9446042368  
Fax    
Email  sreeparvathy.sh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Binod K Khaitan 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Skin OPD,Room 309,3rd floor,New Rajkumari Amrit Kaur OPD,All India Institute of Medical Sciences,New Delh,110029,India
Sri Aurobindo Marg,Ansari Nagar,Ansari Nagar East,New Delhi,Delhi 110029
New Delhi
DELHI
110029
India 
Phone  01126588500  
Fax    
Email  binodkhaitan@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Sree Parvathy V 
Designation  Junior resident 
Affiliation  All India Institute of Medical Sciences 
Address  Skin OPD,Room 309,3rd floor,New Rajkumari Amrit Kaur OPD,All India Institute of Medical Sciences,New Delh,110029,India
Sri Aurobindo Marg,Ansari Nagar,Ansari Nagar East,New Delhi,Delhi 110029
New Delhi
DELHI
110029
India 
Phone  9446042368  
Fax    
Email  sreeparvathy.sh@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East,New Delhi, Delhi 110029  
Type of Sponsor  Government 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 
Sree Parvathy V  All India Institute of Medical Sciences  Room 309 , 3rd floor ,Department of dermatology and venereology , New RAK OPD,Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi
New Delhi
DELHI 		 9446042368

sreeparvathy.sh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L280||Lichen simplex chronicus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multiple daily application of clobetasol propionate 0.05 % cream   Clobetasol propionate, a super potent topical corticosteroid is applied multiple times based on the urge of the patient to itch.The patient applies the cream on a need based manner everyday making a note of the frquenccy of application during the study period of 4 months 
Comparator Agent  Once daily application of clobetasol propionate 0.05%   The patient applies the topical corticosteroid once daily for a period of 4 months  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Patients with clinical diagnosis of lichen simplex chronicus
2.More than 18 years of age
3.Patients with well circumscribed lesions of lichen simplex chronicus. 
 
ExclusionCriteria 
Details  1.Use of systemic medications for treatment of other diseases which may act on the lesion
2.Lichen simplex chronicus due to underlying systemic or dermatological diseases
3.Lichen simplex chronicus superimposed on any other skin lesions
4.Lichen simplex chronicus of the anogenital region
5.Patients who do not consent for study or follow up
6.Pregnant and lactating females. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in the grade of lichenification of the lesion and change in 5 D pruritus score  At the end of 16 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the change in ItchyQol in patients with lichen simplex chronicus who are applying clobetasol propionate cream 0.05% once daily versus itch-based multiple times daily application.  At the end of 16 weeks  
To assess the change in VAS in patients with lichen simplex chronicus who are applying clobetasol propionate cream 0.05% once daily versus itch-based multiple times daily application.  At the end of 16 weeks  
To assess the change in area of lesion in patients with lichen simplex chronicus who are applying clobetasol propionate cream 0.05% once daily versus itch-based multiple times daily application.  At the end of 16 weeks 
To assess the side effects of topical corticosteroids in patients with lichen simplex chronicus who are applying clobetasol propionate cream 0.05% once daily versus itch-based multiple times daily application.  At the end of 16 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 2/ Phase 3 
Date of First Enrollment (India)   28/10/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Lichen simplex chronicus is a chronic pruritic condition characterised by areas of thickened skin caused by habitual itching, scratching and rubbing of the skin.  The standard prescription consists of topical corticosteroids applied once or twice daily but response is usually slow and partial. However in clinical practice it was found that itch-based multiple times application of high potency topical steroids led to reduction in total duration of treatment and thus the total cumulative dose. An itch-based application breaks the itch-scratch cycle and also leads to habit reversal and thus resulting in much better clinical outcome. 
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