| CTRI Number |
CTRI/2024/03/064712 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
21/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Open labelled study for normal and varied findings through trichoscopy assessment in Androgenetic alopecia |
|
Scientific Title of Study
|
Trichoscopic Assessment of Normal and Varied Findings Post Hair Transplantation: A Prospective Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No: CACS (23-24)-012, Version 1, dated: 20 Nov 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Megha C |
| Designation |
Consultant Dermatologist and HOD.of Trichologist |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Department of Trichology
Room No: 19 5/1,4th Main, MRCR Layout
Vijayanagar, Bangalore Bangalore KARNATAKA 560040 India |
| Phone |
8095196167 |
| Fax |
|
| Email |
drmeghacs@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Megha C |
| Designation |
Consultant Dermatologist and HOD.of Trichologist |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Department of Trichology
Room No: 19 5/1,4th Main, MRCR Layout
Vijayanagar, Bangalore
KARNATAKA 560040 India |
| Phone |
8095196167 |
| Fax |
|
| Email |
drmeghacs@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Megha C |
| Designation |
Consultant Dermatologist and HOD.of Trichologist |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Department of Trichology
Room No: 19 5/1,4th Main, MRCR Layout
Vijayanagar, Bangalore
KARNATAKA 560040 India |
| Phone |
8095196167 |
| Fax |
|
| Email |
drmeghacs@gmail.com |
|
|
Source of Monetary or Material Support
|
| CUTIS Academy of Cutaneous Sciences
Department of Trichology
Room No:19
5/1,4th Main, MRCR Layout
Vijayanagar, Bangalore |
|
|
Primary Sponsor
|
| Name |
CUTIS Academy of Cutaneous Sciences |
| Address |
5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore 560040 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Megha C |
CUTIS Academy of Cutaneous Sciences |
Department of Trichology Room No:19 5/1,4th Main, MRCR Layout Vijayanagar, Bangalore Bangalore KARNATAKA |
8095196167
drmeghacs@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: L649||Androgenic alopecia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fotofinder (Trichoscopy) |
To study the post-transplant at the recipient and donor site, to emphasize the microscopic changes in the hair shaft, perifollicular, and interfollicular area on Day 3 and Day 10. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who undergo hair transplantation for Androgenetic Alopecia |
|
| ExclusionCriteria |
| Details |
Hair Transplantaion done in conditions other than AGA. (Scarring alopecia) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Trichoscopic changes on Day 3 and Day 10 following hair transplant at recipient site and donor site |
After 10 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Trichoscopic changes on Day 3 and Day 10 following hair transplant at recipient site and donor site
To emphasize on the microscopic changes in relation to hair shaft, perifollicular and interfollicular area. |
After 10 days |
|
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
05/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="4" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Androgenetic
alopecia (AGA) is a type of patterned hair loss secondary to systemic androgen
and genetic pattern. AGA is the most common type of hair loss in both genders
and result from follicular miniaturisation of hair.[1] It is the
most common type of alopecia among both genders. [2]While the
symptoms may present as early as puberty, prominent changes may be seen from 3rd
decade onwards. They commonly present as hair loss at the crown in females, and
as receding frontal hairline with bitemporal hair loss and vertex thinning in
males. Studies have shown that early hair loss can lead to low self esteem and
psychological stress. [3] [4]Hence early and appropriate
interventions are sought by the patients.
Various
medical, surgical, lightâ€based and nutraceutical treatment options are
available for treatment of androgenetic alopecia. Extent of the condition,
patients need, affordability and aesthetic goals guide the dermatologist and
patient in choosing appropriate management for AGA. [5] [6]Hair
transplant is one of the emerging options for pattern hair loss like AGA. Hair Transplantation includes harvest and
transfer of individual follicular units from donor to recipient site.
Appropriate selection of suitable candidates for hair transplant improves the
outcome of the procedure. [7] Trichoscopy is one such instrument
increasingly used among hair transplantation community to differentiate AGA from
its mimickers like fibrosing alopecia and alopecia areata incognita. [8]
These scalp dermoscopy help in magnified assessment of scalp and hair follicles
in donor and recipient site. In addition of assessment of hair density, hair
follicles and surrounding areas, they store images for future references.
[8] Recent studies [9] [10] are focusing on use of
trichoscopy in post-hair transplantation evaluation of donor and recipient
site. This provides additional information on early erythema, crusting,
folliculitis, scarring on donor and recipient sites. However, these studies are
limited and hence current study is planned. |