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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  
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 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  
Status 
Not Applicable 
 
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, light‐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.

 
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