FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/09/057710 [Registered on: 15/09/2023] Trial Registered Prospectively
Last Modified On: 31/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Study of risk of developing atherosclerosis in young, non-obese women with hair loss 
Scientific Title of Study   Assessment of atherosclerotic risk, in young, non-obese women with female 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  Edna Maria Rodriguez 
Designation  Post graduate resident 
Affiliation  Fr. Muller Medical College 
Address  Fr. Muller Medical College, Department of dermatology, Kankanady, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9741777119  
Fax    
Email  ednamguez2015@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Michelle Serene Fernandes 
Designation  Associate Professor 
Affiliation  Fr. Muller Medical College 
Address  Fr. Muller Medical College, Department of dermatology, Kankanady, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9980785447  
Fax    
Email  michelle@fathermuller.in  
 
Details of Contact Person
Public Query
 
Name  Edna Maria Rodriguez 
Designation  Post graduate resident 
Affiliation  Fr. Muller Medical College 
Address  Fr. Muller Medical College, Department of dermatology, Kankanady, Mangalore


KARNATAKA
575002
India 
Phone  9741777119  
Fax    
Email  ednamguez2015@gmail.com  
 
Source of Monetary or Material Support  
Indian Asoociation of Dermatologists, Venereologists and Leprologists (IADVL) 
 
Primary Sponsor  
Name  Indian Asoociation of Dermatologists, Venereologists and Leprologists (IADVL) 
Address  ADVL National Headquarters, 4772-73 Pvt No.,T-3 & T-4, 3rd Floor, 23 Bharat Ram Road, Darya Ganj, New Delhi-110002. 
Type of Sponsor  Other [ Indian Asoociation of Dermatologists, Venereologists and Leprologists (IADVL )] 
 
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 
Edna Maria Rodriguez  Fr. Muller Medical College  Department Of Dermatology No.65 OPD.
Dakshina Kannada
KARNATAKA 
9741777119

ednamguez2015@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Fr. Muller Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L648||Other androgenic alopecia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.All FPHL cases with a clinical diagnosis who agree to take part in the research.
2.BMI < 30
 
 
ExclusionCriteria 
Details  1.Diffuse hair loss with physiological reasons, such as pregnancy or breastfeeding.
2.Patients taking chronic corticosteroid treatment, hormonal replacement therapy, or contraceptives.
3.Disorders of lipid metabolism or use of medications that could have an impact on lipids.
4.Other causes of alopecia including scarring and non-scarring alopecia
5.Patients with a family history of cardiovascular diseases (CVD).
6.Patients having any inflammatory condition likely to cause a raised CRP.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To estimate the plasma levels of CRP, HDL & triglycerides, and calculate the atherogenic index
2.To measure the Epicardial Adipose Tissue (EAT) thickness using Echocardiography.
3.To correlate atherosclerosis with different grades of FPHL
 
At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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   N/A 
Date of First Enrollment (India)   15/09/2023 
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="1"
Months="6"
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  

Androgenetic alopecia (AGA) in women, also commonly known as Female pattern hair loss (FPHL) is a nonscarring progressive thinning of hair, particularly in the frontal, central, and parietal scalp, as a result of follicular miniaturisation. Numerous studies have demonstrated the unavoidable connection between androgenetic alopecia in males and coronary artery disease. However, a paucity of similar studies in women calls for the need to know a similar association.

Corelating, different grades of FPHL with the severity of atherosclerosis in healthy, young, non-obese women, would help in isolating women who are prone to developing coronary artery disease (CAD). There is abundance of evidence to prove the relationship between concentrations of lipids and lipoproteins with the development of CAD leading to ischaemic heart disease. It has been demonstrated that estimating the atherogenic index, or the log of the ratio of triglycerides to high-density lipoproteins (HDL), is a superior predictor of cardiovascular events.

Numerous circulating markers of inflammation have been studied for their potential to forecast the risk of vascular events because there is a wealth of evidence linking inflammation to atherosclerosis and acute coronary syndromes (ACS). The biomarker that is most researched in this context is C-reactive protein. It is a prognostic indicator for cardiovascular mortality and recurrence for both primary and secondary protection.

 

Additionally, estimation of Epicardial Adipose Tissue (EAT) Thickness provides a major indicator of atherosclerosis linked to cardiovascular risk factors and outcomes.

This study would help in identifying young women who otherwise do not have any disease and are still prone to developing CAD. Diagnosing FPHL and correlating it with atherogenic potential would be a non-invasive way to diagnose CAD earlier.

 
Close