| 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
|
|
|
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
|
|
|
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. |