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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  
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 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  
Status 
Not Applicable 
 
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.

 
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