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CTRI Number  CTRI/2025/11/096766 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 31/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   A comparative study of two laser techniques for tattoo removal. 
Scientific Title of Study   A split tattoo comparative evaluation of sequential QS nanosecond laser followed by QS picosecond laser versus QS picosecond laser alone in tattoo removal: a prospective study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CACS-AD (25-26)-002, Version:1, dated 12 Sep 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chaithra Shenoy 
Designation  Medical Superintendent and HOD Aesthetic Dermatology 
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  Room No:07
Department of Aesthetic Dermatology
Bangalore
KARNATAKA
560040
India 
Phone  9739247155  
Fax    
Email  chaithrashenoy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chaithra Shenoy 
Designation  Medical Superintendent and HOD Aesthetic Dermatology 
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  Room No:07
Department of Aesthetic Dermatology

KARNATAKA
560040
India 
Phone  9739247155  
Fax    
Email  chaithrashenoy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chaithra Shenoy 
Designation  Medical Superintendent and HOD Aesthetic Dermatology 
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  Room No:07
Department of Aesthetic Dermatology

KARNATAKA
560040
India 
Phone  9739247155  
Fax    
Email  chaithrashenoy@gmail.com  
 
Source of Monetary or Material Support  
CUTIS Academy of Cutaneous Sciences 5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore 560040  
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
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 Sona C Gowda  CUTIS Academy of Cutaneous Sciences  Department Aesthetic Dermatology Room No:07 5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore 560040
Bangalore
KARNATAKA 
9483478630

sonacgowda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CUTIS INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L818||Other specified disorders of pigmentation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Q-switched (QS) picosecond laser  On Split Half B, Q-switched (QS) picosecond laser at 532/1064 nm will be applied with a spot size of 3–6 mm, frequency 1–5 Hz, and fluence 1.2–2 J/cm 
Intervention  Q-switched nanosecond laser  On Split Half A, Q-switched nanosecond laser at 532/650/1064 nm (5–10 ns pulse duration) will be applied with a spot size of 3–6 mm, repetition rate of 1–5 Hz, and fluence of 0.5–2 J/cm 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Adults 18 to 70 years willing to consent.
2.One or more stable tattoos (professional or amateur), greater than or equal to 3 months old.
3.Tattoo containing single or multi-colour ink.
4.Agree not to undergo any other tattoo removal procedure during the treatment duration.
 
 
ExclusionCriteria 
Details  1.Associated photo-aggravated skin diseases and medical illnesses, for example, SLE.
2.Treatment area with active cutaneous infection or inflammation.
3.Unstable vitiligo and psoriasis
4.Tattoo granuloma
5.Localised allergic reactions within a tattoo
6.Recent sun exposure in the past 3 weeks
7.Immunosuppression or uncontrolled systemic disease
8.History of keloid and keloidal tendency
9.Personal or family history of skin cancer
10.Photosensitising or gold-containing medication
11.Pregnancy or lactation
12.Seizure disorder
13.Patient not willing to participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Efficacy of tattoo removal: Assessed as the percentage of tattoo clearance using Physician Global Assessment (PGA) scale at baseline and after 4 treatment sessions (week 16)  After 4 months 
 
Secondary Outcome  
Outcome  TimePoints 
The study will assess the efficacy of tattoo removal as the percentage of clearance using the Physician Global Assessment (PGA) scale at baseline and after 4 treatment sessions (week 16). Pain during treatment will be recorded using the Visual Analogue Scale (VAS 0–10) at each session, patient satisfaction will be evaluated on a Likert scale (1–5) after completion of all sessions, and any adverse effects will be documented and graded according to severity.  After 4 months 
 
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   Phase 4 
Date of First Enrollment (India)   14/11/2025 
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="0"
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 - NO
Brief Summary  

Laser tattoo removal was first reported by Goldman et al., and its mechanism is explained by the principles of selective photothermolysis and photoacoustics. According to photothermal theory, laser energy is selectively absorbed by pigment particles, and the optimal pulse duration should be less than or equal to the thermal relaxation time (TRT) of the chromophore. Photon absorption also generates pressure waves, which form the basis of inertial confinement time (ICT). When the laser pulse duration is shorter than the ICT, strong photoacoustic forces rupture the pigment particles. Thus, both theories emphasise the importance of selecting an appropriate wavelength and pulse width for effective and safe tattoo clearance.

Q-switched nanosecond (NS) lasers have long been considered the gold standard due to the selective photothermolysis of tattoo pigments. However, multiple sessions are usually required, with incomplete clearance and risk of pigmentary changes or scarring.

Picosecond (PS) lasers, which have emerged in recent years, are a strong competitor of NS lasers. They have demonstrated superior efficacy by delivering higher peak power with shorter pulse durations, resulting in more effective photomechanical pigment fragmentation and potentially fewer sessions.

Split-tattoo and intra-tattoo comparative trials have generally shown PSL to be superior or at least non-inferior to NSL for many pigments, but most published split studies compare each modality used alone (NSL vs PSL).

Although QS nanosecond lasers remain widely used, and the sequential use of NS followed by PS lasers has been proposed to maximise efficacy, combining the deeper penetration of NS pulses with the finer fragmentation of PS pulses. This sequential approach may enhance tattoo clearance while limiting side effects.

 
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