| 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
|
|
|
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
|
|
|
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 |