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临床试验/CTRI/2025/10/096662
CTRI/2025/10/096662尚未招募不适用

A Study of Clinical, Anthropometric and Hormonal association in Patients Of Female Pattern Hair Loss and healthy controls.

未提供1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2025年11月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
78
试验地点
1
主要终点
1.To determine difference of clinical parameters in subjects with and without FPHL

研究概览

简要总结

Female Pattern Hair Loss (FPHL), also known as androgenetic alopecia, is a progressive, non-scarring alopecia that primarily affects women, leading to significant psychological distress and diminished quality of life. The prevalence of FPHL is increasing in India, yet comprehensive epidemiological and clinical studies remain limited. The pathophysiology of FPHL is multifactorial, involving genetic predisposition, hormonal imbalances, and environmental factors Female Pattern Hair Loss (FPHL) is a common non-scarring alopecia characterized by progressive thinning of hair over the central and frontal scalp regions, most commonly observed in women after puberty. Although often considered a cosmetic issue, emerging evidence suggests that FPHL may be associated with underlying hormonal and metabolic disturbances, including hyperandrogenism, insulin resistance, and features of metabolic syndrome. The present study, titled “Clinical, Anthropometric and Hormonal Study in Patients of Female Pattern Hair Loss,” is designed as a hospital-based, epidemiological, observational, analytic, case control study to investigate and compare the clinical profile, anthropometric measurements, and hormonal parameters in women with FPHL and age-matched healthy controls. The study population includes 76 female patients aged 12 to 46 years clinically diagnosed with FPHL based on the Ludwig classification, along with age-matched controls without clinical signs of hair loss. A comprehensive clinical assessment, trichoscopic examination, and anthropometric evaluation including body mass index (BMI), waist-hip ratio, mid-arm circumference, and body composition analysis will be conducted. In addition, blood samples will be collected to measure hormonal parameters such as serum total and free testosterone, DHEAS, LH, FSH, and prolactin. The primary objective is to determine differences in hormonal and anthropometric profiles between cases and controls, with a view to identifying potential markers that may correlate with disease severity. The sample size was calculated using standard statistical formulas for comparing means, and was based on published reference values for DHEAS and BMI , resulting in an estimated requirement of 38 participants per group to ensure adequate power for both primary outcomes. Statistical analysis will involve appropriate parametric or non-parametric tests to assess the significance of observed differences. This study is expected to contribute to the understanding of FPHL as a multifactorial disorder with systemic implications and may offer insights into early diagnosis, risk stratification, and individualized management strategies.

研究设计

研究类型
Observational

入排标准

年龄范围
12.00 Year(s) 至 46.00 Year(s)(—)
性别
Female

入选标准

  • Case: 1.Female patients with clinical and trichoscopic diagnosis of FPHL.
  • 2.Age between 12-46 year Control: 1.Age-matched healthy females without hair loss.
  • 2.No known dermatological or systemic conditions affecting hair.

排除标准

  • 1.Any pre-existing endocrine disorder like diabetes mellites and thyroid disorder 2.Any known genetic condition effecting the hair 3.Associated Auto immune condition affecting hair like alopecia areata, systemic lupus erythematous 4.Patients on hormonal therapy, hair treatments, or medications affecting hair growth or taking OC Pills in last 2 years 5.Pregnant and lactating females 6.History of abortion in last six months 7.History of any major medical or surgical illness in last six months.

结局指标

主要结局

1.To determine difference of clinical parameters in subjects with and without FPHL

时间窗: day 0

2.To determine difference of anthropometric parament in subjects with and without FPHL

时间窗: day 0

3.To determine difference of hormonal profile in subjects with and without FPH

时间窗: day 0

次要结局

  • 1.To determine the corelation of clinical features & anthropometric parameters in patient of FPHL(2.To determine corelation of the urinary metabolites of androgen metabolism like androstenediol & Androsterone with clinical features in patient of FPH)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Niki Patel

GCS Medical College Hospital and Research Centre

研究点 (1)

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