| CTRI Number |
CTRI/2024/12/077826 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Removal of Keloids using laser treatment (1064nm LP-NdYAG, 595nm Pulsed dye laser and 585nm diode) |
|
Scientific Title of Study
|
Retrospective study on effectiveness of 1064nm LP-NdYAG laser, 595nm Pulsed dye laser and 585nm diode laser in Keloids |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CACS-AS-021, Version 1, Dated 20 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 Varsha Ramani |
CUTIS Academy of Cutaneous Sciences |
5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore 560040 Bangalore KARNATAKA |
7795133801
mvj.varsha@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: L910||Hypertrophic scar, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1064nm LP-NdYAG laser, 595nm Pulsed dye laser and 585nm diode laser |
80-120J/20-30ms/1-2 passes/3-6mm spot size
4.5-5J/cm2/12mm/0.5ms/1-2 passes
3.5-5W/20-30ms/2-3 passes/2-3 stacks
with sessions scheduled every 6 weeks for a total of 4 sessions |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Male and female patients.
Treatment naïve patients |
|
| ExclusionCriteria |
| Details |
Those who have received treatments for keloids previously either medical, surgical or laser therapy
Those who are pregnant or lactating
Patients with a medical condition that might have influenced the wound healing process
Those who have lost to follow up |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The parameters such as age, gender, skin type, number of keloids, area of involvement, laser treatment taken, no of sessions, duration of treatment, treatment outcome and relapse will be noted |
After 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The parameters such as age, gender, skin type, number of keloids, area of involvement, laser treatment taken, no of sessions, duration of treatment, treatment outcome and relapse will be noted |
After 6 months |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
18/12/2024 |
| 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="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
|
Keloid,
meaning “crab’s claw,†was derived from Greek to describe its characteristic clinical
presentation.1 Keloids appear as elevated, firm bosselated papules
and ill-defined plaques accompanied by variation in color, including
erythematous, violaceous, or brown pigmentation.
Given
their composition of haphazardly branched and septal disorganized type I and
III collagen bundles, keloids are often symptomatic with accompanying pain and
pruritus. Following disruption of skin integrity resulting from superficial and
deep injuries, keloids can form within months to years later, causing cosmetic
deformation, functional impairment, psychological distress, and poor quality of
life.1A variety of epidermal to dermal insults are implicated
including iatrogenic surgical incisions, burns, trauma wounds, body piercings,
insect bites, folliculitis, chickenpox, herpes zoster infection, vaccinations,
and acne.1
There
are a wide range of therapies used in treating keloids with various degrees of
success graded by time to recurrence.1 Therapeutic options for
keloids and hypertrophic scars includes surgery, radiation, corticosteroids,
5-fluorouracil, cryotherapy, laser therapy.2
Lasers
and other light-based technology have introduced new ways to manage keloids
that may result in improved aesthetic and symptomatic outcomes and decreased
keloid recurrence. Laser and light-based therapies for keloids can be grouped
into three categories: ablative lasers, non-ablative lasers, and non-coherent
light sources.3
Non
ablative laser therapy includes 585 or 595-nm pulsed dye laser, 1064-nm neodymium-doped:yttrium,
aluminum and garnet (Nd:YAG) laser, 585 diode laser, etc. Currently,
there are no reported studies on the use of the 585 nm diode laser for treating
keloids.
Hence, this
retrospective study seeks to evaluate and compare the effectiveness of the LP-1064nm
NdYAG laser, the 585 nm pulsed dye laser, and the 585 nm diode laser in
keloid treatment, as no existing literature has yet assessed these lasers
comparatively. |