| CTRI Number |
CTRI/2024/02/062983 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of combination of multiple painless modalities in the treatment of Pattern hair Loss |
|
Scientific Title of Study
|
Efficacy of combination of Skin Micro-incision, Pressure Wave Stimulation, Electrostimulation and Photostimulation in the treatment of Pattern hair Loss |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun Kumar Jacob R |
| Designation |
Senior Resident |
| Affiliation |
Sri Muthukumaran Medical College and reserarch institute |
| Address |
Room No 113, Department of Dermatology,
Sri Muthukumaran Medical College and Research Institute
Kancheepuram
TAMIL NADU
6000069
India |
| Phone |
9176330844 |
| Fax |
|
| Email |
arujako@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Karthik Raja |
| Designation |
Associate Professor |
| Affiliation |
Sri Muthukumaran Medical College and Research Instititue |
| Address |
Room No 113,
Deparment of Dermatology,
Sri Muthukumaran Medical college and Research Institute,
Kancheepuram
TAMIL NADU
600069
India |
| Phone |
7550204515 |
| Fax |
|
| Email |
skindoctorkarthik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karthik Raja |
| Designation |
Associate Professor |
| Affiliation |
Sri Muthukumaran Medical College and Research Instititue |
| Address |
Room No 113,
Deparment of Dermatology,
Sri Muthukumaran Medical college and Research Institute,
Kancheepuram
TAMIL NADU
600069
India |
| Phone |
7550204515 |
| Fax |
|
| Email |
skindoctorkarthik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Muthukumaran Medical College and Research Institute |
|
|
Primary Sponsor
|
| Name |
Karthik raja |
| Address |
183, Ettayapuram Road, Kovilpatti |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Karthikraja |
Sri Muthukumaran Medical college and Research Institute |
Room No 113,
Deparment of Dermatology,
Sri Muthukumaran Medical College and Research Institute,
Chikkarayapuram,
Chennai - 600069
Kancheepuram
TAMIL NADU |
7550204515
skindoctorkarthik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Muthukumaran Medical College And Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L649||Androgenic alopecia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Comparator as it is a Single arm uncontrolled trial |
Starting point and after 3 months |
| Intervention |
Skin Micro-incision, Pressure Wave Stimulation, Electrostimulation and Photostimulation |
The device consists of 2 probes. The first probe will deliver pressure and micro-incisions by tapping. The micro-incisions are upto a depth of 0.25mm, which will not penetrate into the dermis. This is followed by electric stimulation with activation time of 300 micro seconds and a frequency of 2Hz, which will be delivered by another probe. This probe also simultaneously provides photostimulation at a wavelength of 632nm (Red).
The Intervention duration is 3 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 25 to 45, suffering from pattern hair loss, which includes Androgenetic Alopecia(AGA) and Female Pattern hair Loss(FPHL).
|
|
| ExclusionCriteria |
| Details |
Patients with scarring alopecia
Patients with other non-scarring alopecias
Patients with relevant co-morbidities (Anemia, Thrombocytopenia, Hypo-Hyperthyroidism, Vitamin B D deficiency)
Patients on other treatment for AGA,FPHL
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| No of new hair follicles in 1 sq cm area |
Before study, after 1 month of completion of 4th session |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No of terminal hairs in 1 sq cms area |
Before study, after 1 month of completion of 4th session |
| Hair Color |
Before study, after 1 month of completion of 4th session |
|
|
Target Sample Size
|
Total Sample Size="87"
Sample Size from India="87"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/02/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included Online).
- For how long will this data be available start date provided 09-01-2025 and end date provided 09-01-2040?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a hospital based uncontrolled trial. Patients with AGA or FPHL will first be examined after getting relevant consent. Photographs will be taken of the front, vertex, lateral and back of the scalp. The severity will then be assessed by Hamilton-Norwood scale for AGA and Ludwig scale for FPHL. Hair pull test will be done and hair count, density, thickness and colour will be noted. Patient will then be subjected to the study device. The guide has been trained in Italy on the proper usage of the device and will train the principal investigator regarding the same. The device consists of 2 probes. The first probe will deliver pressure and micro-incisions by tapping. The micro-incisions are upto a depth of 0.25mm, which will not penetrate into the dermis. This is followed by electric stimulation with activation time of 300 micro seconds and a frequency of 2Hz, which will be delivered by another probe. This probe also simultaneously provides photostimulation at a wavelength of 632nm (Red). Pain experienced during the procedure will be graded using Numerical Rating Scale (NRS). Other side effects, if any, will be noted. The sessions will be repeated once every 3 weeks for a total of 4 sessions. Following 4 sessions, improvement in patient satisfaction, grade, hair pull, count, density, thickness and colour will be assessed. Photographs will be taken as above and compared. Analysis will be done using SPSS Software 21.0. |