| 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
|
|
|
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
|
|
|
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. |