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CTRI Number  CTRI/2024/12/077707 [Registered on: 05/12/2024] 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   Effect of 1064nm LP-Nd Yag laser and 755nm Alexandrite laser in the treatment of under arms hair removal. 
Scientific Title of Study   Efficacy of 1064nm LP-Nd Yag laser verses 755nm Alexandrite laser for axillary hair reduction in skin of color: A prospective comparison study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CACS-AS-015, Version.1, Dated,10 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 Chaithra Shenoy  CUTIS Academy of Cutaneous Sciences  CUTIS Academy of Cutaneous Sciences Department of Aesthetic Dermatology, Room No:7 5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore 560040
Bangalore
KARNATAKA 
9739247155

chaithrashenoy@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: L689||Hypertrichosis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  alexandrite 755 nm laser  20mm spot size and fluence starting at 4J/cm2/1200ce in motion,with sessions scheduled every 6 weeks for a total of 4 sessions. 
Intervention  LP-Nd Yag laser  15mm spot size and a fluence starting at 26-28 J/cm² for 40 milliseconds, 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  Female 
Details  Age above 18 years
Fitzpatrick Skin Type (FST) IV,V 
 
ExclusionCriteria 
Details  Pregnancy/lactation, white hairs in the axilla, photosensitivity/ on photosensitive drugs, scar/keloid tendency, history of skin diseases known to show Koebner’s phenomenon, unrealistic expectations/body dysmorphic disorders, previous laser or electrolysis treatment and epilation or waxing in the period of 2 months prior to the start of the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the efficacy and safety of LP-Nd Yag laser versus Alexandrite laser for axillary hair reduction in skin of color population  After 6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
To determine assessment of improvement with trichoscopy using FotoFinder.
To determine Patient satisfaction based on discomfort level using 10‐point visual analogue scale (VAS) for each side.
Subjective assessment using global photographs using 4 point grading scale poor (0%– 25% reduction), moderate (26%– 50%), significant (51%– 75%), and excellent (76%– 100%) 
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   Phase 4 
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="0"
Months="8"
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 hair reduction (LHR) is a popular cosmetic dermatology procedure utilizing several types of lasers along with non-laser intense pulse light (IPL) epilators.2 LHR being a slow process, requires at least six to eight sessions and spaced depending on the hair cycle of the target area for satisfactory results.The principle behind effectiveness of LHR systems is extended theory of selective photothermolysis.1 Specific wavelengths of 600 to 1100 nm target the melanin in the hair follicle and converts it into heat, thermal damage to the stem cells in the hair bulge inhibits future hair regrowth. With repeated sessions, hair regrowth becomes sparser and finer, extending the duration of hair-free intervals.

Different laser systems offer a range of wavelength, from the 694-nm Ruby laser, to the 755-nm Alexandrite (Alex) laser, 800- 810nm Diode and the 1064-nm Nd: YAG laser, with IPL devices covering a broad spectrum from 515 to 1200 nm1. The Nd-Yag was the first laser for epilation to receive FDA approval. Each system’s efficacy and safety vary across different skin and hair types. The Nd- yag laser (1064) stands out for its efficacy and safety particularly for darker skin types (Fitzpatrick skin types IV - VI), due to its deeper penetration and reduced melanin absorption, minimizing epidermal damage6.

However, the Nd:YAG laser has lower melanin absorption limiting its effectiveness on finer and lighter colored hair, potentially requiring more sessions to achieve the desired outcomes6. Conversely, the 755nm alexandrite is very good at targeting melanin in hair follicles particularly is effective for lighter skin types. It offers balance of safety, comfort, effectiveness of long term hair reduction. However, it necessitates a careful understanding for use in darker skin types to minimize adverse effects, given its higher melanin affinity.5

Axillary hair is dark and terminal and requires laser with maximum melanin absorption for effective hair reduction which can be done with alexandrite laser 1 but for skin of color with more epidermal melanin LP-Nd Yag with minimal melanin absorption is safe1.

To the best of our knowledge no studies specifically analyze their efficacy in the dark skin types. Thus, this study aims to address this gap by evaluating the effectiveness and safety of the LP Nd -Yag and Alexandrite lasers in axillary LHR for individuals with skin of color. 

 
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