| CTRI Number |
CTRI/2025/10/096113 [Registered on: 15/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Trichoscopic features of female pattern hair loss and their association with metabolic syndrome and fatty liver: a hospital-based case–control study. |
|
Scientific Title of Study
|
A case control study of trichoscopic evaluation of female pattern hair loss and its corelation with metabolic syndrome and fatty liver |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Aggarwal |
| Designation |
First Year Dermatology Post graduate |
| Affiliation |
Kasturba medical college, Mangalore |
| Address |
Department of Dermatology, 203,Light House Hill Rd, Hampankatta, Mangaluru
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9811331053 |
| Fax |
|
| Email |
paggarwal519@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Deepti Dsouza |
| Designation |
Associate Professor |
| Affiliation |
Kasturba medical college, Mangalore |
| Address |
Department of Dermatology, KMC Attavar Hospital,Nandigudda Rd, Attavar, Mangaluru
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9811331053 |
| Fax |
|
| Email |
deepti.dsouza@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Aggarwal |
| Designation |
First year Dermatology Post graduate |
| Affiliation |
Kasturba medical college, Mangalore |
| Address |
Kasturba Medical College,203,Light House Hill Rd, Hampankatta, Mangaluru
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9811331053 |
| Fax |
|
| Email |
paggarwal519@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Indian Association of Dermatologists, Venereologists, and Leprologists (IADVL) , 314-315, 3rd Floor KM Trade Tower, H 3, Sector 14, Kaushambi, Ghaziabad, Uttar Pradesh, 201010 |
|
|
Primary Sponsor
|
| Name |
IADVL |
| Address |
314-315,
3rd Floor KM Trade Tower,
H 3, Sector 14, Kaushambi,
Ghaziabad,Uttar Pradesh. 201010 |
| Type of Sponsor |
Other [DERMATOLOGISTS ASSOCIATION] |
|
|
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 POOJA AGGARWAL |
KASTURBA MEDICAL COLLEGE, MANGALORE |
Room no. 9,Department of Dermatology,KMC Attavar Hospital, Nandigudda Rd, Attavar, Mangaluru, Karnataka 575001
Dakshina Kannada
KARNATAKA |
9811331053
paggarwal519@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC, MANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L64||Androgenic alopecia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Females more than 18 years of age .
Patients willing to give consent.
For cases Patients clinically diagnosed with FPHL.
For control Healthy females without any signs of alopecia or scalp disorders matched for age and gender.
|
|
| ExclusionCriteria |
| Details |
Patients less than 18 years of age.
Patients who are not willing to participate.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of Metabolic Syndrome and hepatic steatosis in FPHL patients. |
At the first visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation between FPHL severity (clinical & trichoscopic grading) & metabolic parameters. |
at time of data analysis that at the end of data collection |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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)
|
19/10/2025 |
| 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 Applicable |
| 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
|
Public title: Trichoscopic features of female pattern hair loss and their association with metabolic syndrome and fatty liver a hospital based case control study
Scientific title: A case control study of trichoscopic evaluation of female pattern hair loss and its correlation with metabolic syndrome and nonalcoholic fatty liver disease
Health condition studied: Female pattern hair loss metabolic syndrome fatty liver
Study design: Observational analytical hospital based case control with one to one matching cases are FPHL and controls are age matched women without alopecia
Study setting and site: Dermatology outpatient department teaching hospitals attached to Kasturba Medical College Mangalore Manipal Academy of Higher Education India
Participants: Females aged 18 years and above
Cases: Clinical diagnosis of female pattern hair loss
Controls: Age matched females without clinical hair loss
Inclusion criteria: Women 18 years or older willing to give consent for cases clinical female pattern hair loss for controls no alopecia or scalp disorder
Exclusion criteria: Age below 18 years unwilling to participate conditions that may confound scalp assessment
Sample size: Total 112 with 56 cases and 56 controls
Study duration: 18 months anticipated first enrolment June 2025 and anticipated completion November 2026
Recruitment status: Not yet recruiting
Assessments and procedures:
Clinical data demographics body mass index waist circumference blood pressure and grading of female pattern hair loss using Ludwig and Sinclair scales
Trichoscopy at ten times polarized magnification over central frontal and parietal scalp recording hair shaft diameter diversity yellow dots peripilar signs and follicular unit changes
Biochemistry fasting glucose lipid profile fasting insulin by ELISA with calculation of HOMA IR
Ultrasound abdomen for fatty liver grading from 0 to 3
Definition of metabolic syndrome by NCEP ATP III at least three of five components
Primary outcomes: Prevalence of metabolic syndrome in cases versus controls and prevalence of fatty liver in cases versus controls
Secondary outcomes: Correlation of female pattern hair loss severity clinical and trichoscopic with metabolic parameters waist circumference blood pressure lipids glucose insulin HOMA IR and ultrasound fatty liver grade
Data analysis: Descriptive statistics chi square test for categorical variables t test or Mann Whitney U test for continuous variables significance level 0 point 05 software IBM SPSS version 29
Ethics: Institutional Ethics Committee approval will be obtained before enrolment written informed consent will be taken confidentiality will be maintained
Funding and sponsor: IADVL GRANT
Keywords: female pattern hair loss trichoscopy metabolic syndrome fatty liver HOMA IR case control India |