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CTRI Number  CTRI/2024/12/077588 [Registered on: 03/12/2024] Trial Registered Prospectively
Last Modified On: 02/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   Comparing standard PICO second laser and combination of fractional and standard picosecond laser in the treatment of tattoo removal. 
Scientific Title of Study   Safety and efficacy of standard PICO second laser alone and in combining with fractional picosecond laser in the treatment of tattoo removal - a prospective split study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CACS-AS-017, Version 1, Dated 14 Sep 2024  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  Department of Aesthetic Dermatology Rooma No: 7
5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore
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  Department of Aesthetic Dermatology Rooma No: 7
5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore

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  Department of Aesthetic Dermatology Rooma No: 7
5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore

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  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 Uday Kumar  CUTIS Academy of Cutaneous Sciences  5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore 560040
Bangalore
KARNATAKA 
7010669215

udhaykumaracad@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 
Intervention  combination of Fractional and standard picosecond laser  4 mm spot size and fluence starting at 0.8-1J/cm2/1 pass + fractional picosecond laser will be done with 8mm spot size and fluence starting at 0.4- 0.5J/cm2/2 passes, with sessions scheduled every 6 weeks for a total of 4 sessions. 
Comparator Agent  STANDARD PICO SECOND LASER  4 mm spot size and fluence starting at 0.8-1J/cm2/1 pass, with sessions scheduled every 6 weeks for a total of 4 sessions. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All Patients of age 18 to 60 years wants to remove unwanted tattoos
Patients willing to participate in the study with their informed consent
Patients not undergoing any other treatment for the same 
 
ExclusionCriteria 
Details  Associated photoaggravated skin diseases and medical illness, for example, systemic lupus erythematosus.
Treatment area with active cutaneous infections, for example, herpes labialis, staphylococcal infections.
Unstable vitiligo and psoriasis for risk of Koebnerization of the treated area.
Tattoo granuloma
Patients with skin malignancy
Pregnancy and Lactation women
Bindi tattoo
Have taken any treatment in the past for tattoo removal  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To determine the efficacy of standard picosecond laser in the treatment of tattoo removal
3.Efficacy of the Fractional Picosecond laser and standard Picosecond laser in tattoo removal 
After 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Physician global assessment (PGA) evaluation using four point scale with Grades of 1 minimal, 2 moderate, 3 marked and 4 near total improvement. Baseline and at weeks 6,12,18 and 24 weeks  After 6 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   N/A 
Date of First Enrollment (India)   17/12/2024 
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="0"
Months="6"
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  

Tattooing is an ever-increasing phenomenon and has become an accepted form of beautification, self-expression, and art. As commonly as people get themselves tattooed, many of them seek its removal at some point in time. Lasers have superseded other older modalities of tattoo removal such as dermabrasion, salabrasion, chemical cauterization/ peel, cryotherapy, and surgical excision.

Laser therapy is the gold standard method to remove unwanted tattoos.1 It is available and widely accessible. In the 1980s, the vaporizing CO 2 and erbium:YAG lasers, and argon lasers, were used to remove tattoo pigment but again resulted in scarring.  

 Anderson and Parrish’s principle of selective photothermolysis revolutionized the treatment of tattoos.2 whereby an extremely short pulse width was delivered less than the thermal relaxation time (TRT) of a target.

The Q-switched laser has pulse duration in nanosecond (10-9 of a second). If the pulse duration is narrowed further, the peak energy of the laser beam becomes very high. The picosecond lasers have a pulse duration of (10-12 of a second).3 A variety of holographic or diffractive lens arrays can be used to produce fractional picosecond laser energy. These arrays allow the energy to be concentrated within laser microbeams, while neighboring tissue between the microspots is unharmed.4

 Commercially available fractional optical delivery technologies include, diffractive lens arrays (DLA), micro-lens arrays (MLA), and holographic optical arrays.5 Nanosecond laser treatment relies mainly on photothermolysis rather than photomechanical effects; however, picosecond lasers rely mainly on photoacoustic destruction.6 This approach can enhance the energy transmitted to target cells within the lesion, and avoid thermal damage to surrounding tissues. 7

This results in more rapid heating of the tattoos and finer fragmentation. The lymphatic elimination of these finer particles is easier resulting in faster clearing of the tattoos.3 In 2012, the FDA approved the first picosecond laser for skin applications (Picosure, Cynosure, Westford, Massachusetts).8 The picosecond lasers with pulse durations in the range of 450–750 ps were introduced commercially in early 2013. At present, there are three or more systems with a wavelength of 755 nm and 1,064 nm and a pulse duration of 450–750 ps.8

 
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