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CTRI Number  CTRI/2017/06/008756 [Registered on: 05/06/2017] Trial Registered Prospectively
Last Modified On: 02/06/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Laser]  
Study Design  Single Arm Study 
Public Title of Study   Laser for lichen planus pigmentosus 
Scientific Title of Study   Effect of Q-switched Nd-YAG laser on the clinical, pigmentary and immunological markers in the patients with lichen planus pigmentosus: A pilot study 
Trial Acronym  Nd-YAG in LPP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neetu Bhari 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Science, New Delhi 
Address  Room no 4078A, Teaching block, 4th floor, Department of Dermatology and Venereology, Ansari Nagar

New Delhi
DELHI
110049
India 
Phone  9650437049  
Fax    
Email  drntbhari@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neetu Bhari 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Science, New Delhi 
Address  Room no 4078A, teaching block, 4th floor, Department of Dermatology, Ansari Nagar

New Delhi
DELHI
110049
India 
Phone  9650437049  
Fax    
Email  drntbhari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neetu Bhari 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Science, New Delhi 
Address  Room no 4078A, teaching block, 4th floor, Department of Dermatology, Ansari Nagar

New Delhi
DELHI
110049
India 
Phone  9650437049  
Fax    
Email  drntbhari@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi, India 
 
Primary Sponsor  
Name  Intramural Project All India Institute of Medical Sciences 
Address  Ansari nagar, New Delhi 
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 Neetu Bhari  All India Institute of Medical Sciences  Room no 4078A, teaching block, 4th floor, Department of Dermatology, Ansari Nagar
New Delhi
DELHI 
9650437049

drntbhari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics commite  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Lichen planus pigmentosus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nd-YAG laser  6 sittings will be done on a lesion present at the covered body site, at 2 weekly interval 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients presenting with slate-gray hyperpigmented macules over neck, trunk or extremities
2. Histological evaluation showing minimal inflammatory infiltrate with presence of dermal pigment
 
 
ExclusionCriteria 
Details  1. The presence of dense inflammatory infiltrate in dermis
2. Age less than 18 years
3. Patients not able to follow-up frequently
4. Patients with active infections, keloidal tendency, clotting abnormalities and serious systemic diseases
5. Pregnant or lactating females
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical improvement in pigmentation in patients with lichen planus pigmentosus with 6 sessions of Q switched Nd-YAG laser for 3 months at 2-weeks interval.
 
Patient and physician assessment of improvement as well as objective measurement of reduction in melanin pigment will be done at each visit and after 2 weeks of last laser visit 
 
Secondary Outcome  
Outcome  TimePoints 
Detailed evaluation of the effect of laser on the dermal melanin pigment and melanophages in these patients. This will be done by comparing the pre and post treatment immunohistochemistry and mRNA expression analysis of MART-1, tyrosinase, MITF, CD68 and CD163.  In five patients, post-treatment analysis done immediately one hour after the first laser session will help in determining the immediate effect of the laser on the destruction of melanophages and melanin. In the remaining five patients, this analysis done 2 weeks after the last laser visit will help in evaluation of long term effect of the laser on these cells. 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   16/06/2017 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Lichen planus pigmentosus (LPP) is a pigmentary disorder characterized by persistent and asymptomatic slate-gray pigmentation over face, neck and flexures. This results in severe cosmetic disability and morbidity. Existing treatment options have shown minimal to nil improvement. The persistent pigmentation is secondary to persistent melanophages in the papillary dermis resistant to medical therapies. Q-switched Nd-YAG laser is known to disrupt the melanin pigment in the dermis via photothermolysis. We plan to undertake this pilot study to evaluate the effect of Q-switched Nd-YAG laser in the management of 10 patients of lichen planus pigmentosus. Six laser sessions will be performed at 2-weekly interval using a low fluence skin toning protocol. Patient and physician assessment of improvement as well as objective measurement of  melanin and erythema index will be done at each visit and 2 weeks after the last laser session. Since, there are no proper study available evaluating the effect of Nd-YAG laser in LPP, we also plan to study the laser induced changes in immunological and pigmentary markers pre and post treatment which will be done by analysis of immunohistochemistry and mRNA expression of melanin pigment markers as MART-1, MITF and tyrosinase and macrophage markers as CD68 and CD163. This will be done one hour after the first laser session in five patients and after 2-weeks of last laser session in remaining five patients.

 
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