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CTRI Number  CTRI/2026/03/106326 [Registered on: 16/03/2026] Trial Registered Prospectively
Last Modified On: 14/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Comparison of Two Lasers for Treating Skin Pigmentation Problems 
Scientific Title of Study   COMPARATIVE STUDY OF Q SWITCHED ND YAG LASER VS PICOSECOND LASER FOR TREATMENT OF VARIOUS PIGMENTARY DISORDERS USING A SPLIT LESION DESIGN 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Amogh Kirtane 
Designation  Resident Doctor 
Affiliation  Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital 
Address  Department of Dermatology and Venereology and Leprosy, OPD No. 28, ground floor, Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital, Old Thane-Belapur road, Kalwa, Thane.

Thane
MAHARASHTRA
400605
India 
Phone  9637598552  
Fax    
Email  kirtaneamogh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Pradnya Joshi 
Designation  Associate Professor and Head of Department(Dermatology) 
Affiliation  Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital 
Address  Department of Dermatology and Venereology and Leprosy, OPD No. 28, ground floor, Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital, Kalwa, Thane.

Thane
MAHARASHTRA
400605
India 
Phone  8108735566  
Fax    
Email  drpradnyarjoshi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Amogh Kirtane 
Designation  Resident Doctor 
Affiliation  Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital 
Address  Department of Dermatology and Venereology and Leprosy, OPD No. 28, ground floor, Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital, Old Thane-Belapur road, Kalwa, Thane.

Thane
MAHARASHTRA
400605
India 
Phone  9637598552  
Fax    
Email  kirtaneamogh@gmail.com  
 
Source of Monetary or Material Support  
Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital, Old Thane-Belapur road, Kalwa, Thane, Maharashtra, India 400605 
 
Primary Sponsor  
Name  Department of Dermatology and Venereology and Leprosy 
Address  OPD No. 28, ground floor, Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital, Old Thane-Belapur road, Kalwa, Thane. 
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 
Dr Amogh Kirtane  Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital  Department of Dermatology and Venereology and Leprosy, OPD No. 28, ground floor
Thane
MAHARASHTRA 		 9637598552

kirtaneamogh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee RGMC And CSMH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L812||Freckles, (2) ICD-10 Condition: L813||Cafe au lait spots, (3) ICD-10 Condition: L814||Other melanin hyperpigmentation, (4) ICD-10 Condition: L818||Other specified disorders of pigmentation, (5) ICD-10 Condition: L819||Disorder of pigmentation, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Picosecond Nd:YAG laser  Comparing the efficacy and safety of Q switched and Picosecond lasers study duration is of 1.5 years 
Intervention  Q Switched Nd:YAG laser  Comparison of efficacy and safety of picosecond Nd:YAG vs Q Switched Nd:YAG laser Study duration is 1.5 years 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients above 18 years.
Presence of one or more hyperpigmentary disorders amenable to Nd:YAG laser therapy as per the literature.
No treatment taken for the condition (topical/ oral/ procedural) in the last 6 months.
Written informed consent to participate in the study and comply with the treatment schedule, follow-up appointments, and post-treatment care instructions.
 
 
ExclusionCriteria 
Details  Unwillingness to consent to participate in the study.
Pregnancy and Lactation.
Increased Sensitivity to Light.
Scars or Florid inflammation of the tattooed skin or area immediately surrounding it.
Treatment taken for the pigmentary condition in the last 6 months.
Active Skin Conditions:
No Active cutaneous infections (bacterial, viral, or fungal) in or near the treatment area.
No History of recurrent herpes simplex virus infection in the treatment area, unless prophylactic antiviral therapy is administered.
No Active disease with Koebnerization such as lichen planus pigmentosus, Riehl’s melanosis, etc.
Concomitant treatment for the pigmentary condition except sunscreen.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Picosecond Nd:YAG laser may perform better than Q Switched Nd:YAG in terms of safety and efficacy  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   25/03/2026 
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   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 [dermatamogh@gmail.com].

  6. For how long will this data be available start date provided 15-05-2027 and end date provided 20-05-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Pigmentary disorders are common dermatological conditions that frequently affect individuals with skin of color, including Asian and Indian populations, often causing significant psychosocial distress
The visible nature of these lesions commonly impacts an individuals quality of life
The following study will compare the efficacy and safety profiles of both picosecond Nd:YAG and Q Switched Nd:YAG lasers for hyperpigmentary diorders in Indian skin type
This study would first of its kind especially in Indian population
 
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