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临床试验/CTRI/2025/10/096113
CTRI/2025/10/096113尚未招募不适用

A case control study of trichoscopic evaluation of female pattern hair loss and its corelation with metabolic syndrome and fatty liver

IADVL1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2025年10月19日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
IADVL
入组人数
116
试验地点
1
主要终点
Prevalence of Metabolic Syndrome and hepatic steatosis in FPHL patients.

研究概览

简要总结

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

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
Female

入选标准

  • 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.

排除标准

  • Patients less than 18 years of age.
  • Patients who are not willing to participate.

结局指标

主要结局

Prevalence of Metabolic Syndrome and hepatic steatosis in FPHL patients.

时间窗: At the first visit

次要结局

  • Correlation between FPHL severity (clinical & trichoscopic grading) & metabolic parameters.(at time of data analysis that at the end of data collection)

研究者

发起方
IADVL
申办方类型
Other [DERMATOLOGISTS ASSOCIATION]
责任方
Principal Investigator
主要研究者

Pooja Aggarwal

Kasturba medical college, Mangalore

研究点 (1)

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