| 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
|
|
|
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
|
|
|
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 10â€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. |