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临床试验/NCT04292587
NCT04292587Unknown不适用

Prevalence of Hirsutism in Turkey: Data of The Dermatoendocrinology Study Group

Istanbul Medeniyet University26 个研究点 分布在 1 个国家目标入组 5,861 人开始时间: 2020年2月3日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
5,861
试验地点
26
主要终点
Modified Ferriman-Gallwey Scoring System for Severity of Hirsutism

研究概览

简要总结

Hirsutism is defined as the excessive presence of terminal hairs in the androgen-sensitive areas of the female body, and it is one of the frequent reasons for presenting to dermatology outpatient clinics. Hirsutism influences 5% to 10% of women around the world and leads to psychological problems depending on ethnic and socio-cultural factors. It also causes material burden including medicines, cosmetic products and epilation procedures.

The differences in the real prevalence of hirsutism in the Turkish population and the hirsutism prevalence and severity between the geographical regions of Turkey are not known. In this study, we aimed to determine the prevalence of hirsutism in women at the reproductive age within Turkey. The geographical regions of Turkey comprise seven regions and and all regions were included in this study. By considering the regions where ethnic differences were high including the east-west-south and north of our country, we aimed to find an answer to the question of whether there were differences in terms of the prevalence and severity of hirsutism among these regions. A comprehensive study aiming to determine the prevalence of hirsutism in Turkey has not been conducted.

详细描述

Twenty-two provinces of Turkey's seven regions and 26 hospitals from these provinces will be included in the study. The number of samples was specified by the public health specialist on the 2018 census figures. The Turkish population consists of 80,810,525 people according to the data announced by the Turkish Statistical Institute in 2018. In order to determine the prevalence in Turkey, the sample size was calculated with a confidence interval of 99% and error margin of 1%, and the total number of individuals to be screened was designated as 5861. The number of patients to be screened via the clustering method weighted by regions was specified as 1800 for the Marmara Region, 750 for the Aegean Region, 744 for the Mediterranean Region, 568 for the Black Sea Region, 932 for the Central Anatolia Region, 434 for the Eastern Anatolia Region and 633 for the Southeastern Anatolia Region. The provinces that were thought to represent each region were selected via the cluster sampling method.

During the study period, female patients aged between 18 and 45, who present to dermatology outpatient clinics, will be examined clinically until the number of patients designated for each study center is reached, and the hirsutism level of the patients diagnosed with hirsutism will be determined by using the modified Ferriman-Gallwey (mFG) scoring system. In this system, hair growth in nine regions (upper lip, chin, chest, upper back, lower back, upper abdomen, lower abdomen, upper arms and thighs) is graded between 0 and 4. And nine regions are scored between 0 (no terminal hairs) and 4 (excessive presence of terminal hairs). The score above 8 is considered hirsutism. The hirsutism family history, body mass index, menstrual cycle pattern, concomitant disease status (diabetes, hyperlipidemia, hypertension, thyroid disease), history of medication causing body hair growth, the acne presence and severity, presence and severity of androgenic alopecia, presence of seborrhea, presence and localization of acanthosis nigricans, presence of acrochordon, presence of hidradenitis suppurativa, presence of galactorrhea, presence of virilization symptoms and presence of cushingoid symptoms of all the examined patients will be investigated and recorded.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients aged between 18 and 45, who presented to the dermatology outpatient clinics for any reason
  • Not being in pregnancy and lactation period
  • Not applying permanent epilation
  • Not using temporary hair reduction methods in the last 4 weeks
  • Not using oral contraceptive, corticosteroid, cyclosporin or spironolactone in the last 3 months

排除标准

  • Female patients below the age of 18, above 45 and men in any age group
  • Pregnant women and women in lactation period
  • Patients who had permanent epilation
  • Patients who had temporary hair reduction methods in the last 4 weeks
  • Patients taking oral contraceptive, corticosteroid, cyclosporin or spironolactone in the last 3 months

结局指标

主要结局

Modified Ferriman-Gallwey Scoring System for Severity of Hirsutism

时间窗: 1 day (At the time of the examination)

In this system, hair growth in nine regions (upper lip, chin, chest, upper back, lower back, upper abdomen, lower abdomen, upper arms and thighs) is graded between 0 and 4. And nine regions are scored between 0 (no terminal hairs) and 4 (excessive presence of terminal hairs). The score above 8 is considered hirsutism.

次要结局

  • The presence and severity of androgenic alopecia in the participants(1 day (At the time of the examination))
  • Body mass indices of the participants(1 day (At the time of the examination))
  • The presence and severity of acne in the participants(1 day (At the time of the examination))
  • Number of Participants With Concomitant disease status and the risk factors(1 day (At the time of the examination))
  • Menstrual cycle pattern of the participants(1 day (At the time of the examination))

研究者

发起方
Istanbul Medeniyet University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Filiz Cebeci Kahraman

Associate Professor

Istanbul Medeniyet University

研究点 (26)

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