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

March 1, 2020 updated by: Filiz Cebeci Kahraman, Istanbul Medeniyet University

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

5861

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Adana, Turkey, 01358
      • Aksaray, Turkey, 68000
        • Recruiting
        • School of Medicine, Aksaray University
        • Contact:
      • Ankara, Turkey, 06010
        • Recruiting
        • School of Medicine, Ankara Yıldırım Beyazıt University
        • Contact:
      • Aydın, Turkey, 09100
        • Recruiting
        • School of Medicine, Aydın Adnan Menderes University
        • Contact:
      • Bitlis, Turkey, 13200
      • Bursa, Turkey, 16285
        • Recruiting
        • School of Medicine, Uludag University
        • Contact:
      • Diyarbakır, Turkey, 21070
        • Recruiting
        • University of Health Sciences, Gazi Yasargil Training and Research Hospital
        • Contact:
      • Edirne, Turkey, 22030
        • Recruiting
        • School of Medicine, Trakya University
        • Contact:
      • Eskisehir, Turkey, 26040
        • Recruiting
        • School of Medicine, Eskisehir Osmangazi University
        • Contact:
      • Gaziantep, Turkey, 27310
        • Recruiting
        • School of Medicine, Gaziantep University
        • Contact:
      • Isparta, Turkey, 32260
        • Recruiting
        • School of Medicine, Süleyman Demirel University
        • Contact:
      • Istanbul, Turkey, 34899
        • Recruiting
        • Marmara University Pendik Training and Research Hospital
        • Contact:
      • Istanbul, Turkey, 34147
        • Recruiting
        • University of Health Sciences, Bakırköy Sadi Konuk Training and Research Hospital
        • Contact:
      • Istanbul, Turkey, 34668
        • Recruiting
        • University of Health Sciences, Sultan 2. Abdulhamid Han Training and Research Hospital
        • Contact:
      • Istanbul, Turkey, 34730
        • Recruiting
        • Istanbul Medeniyet University, Goztepe Research and Training Hospital
        • Contact:
      • Istanbul, Turkey, 34764
        • Recruiting
        • University of Health Sciences, Ümraniye Training and Research Hospital
        • Contact:
      • Izmir, Turkey, 35620
        • Recruiting
        • School of Medicine,Izmir Katip Celebi University
        • Contact:
      • Kahramanmaras, Turkey, 46050
        • Recruiting
        • School of Medicine,Kahramanmaras Sutcu Imam University
        • Contact:
      • Kocaeli, Turkey, 41001
        • Recruiting
        • School of Medicine, Kocaeli University
        • Contact:
      • Konya, Turkey, 42090
        • Recruiting
        • Meram School of Medicine, Necmettin Erbakan University
        • Contact:
      • Manisa, Turkey, 45140
        • Recruiting
        • School of Medicine, Celal Bayar University
        • Contact:
      • Sanlıurfa, Turkey, 63300
        • Recruiting
        • Şanlıurfa training and research hospital
        • Contact:
      • Tekirdag, Turkey, 59030
        • Recruiting
        • School of Medicine, Namık Kemal University
        • Contact:
      • Tokat, Turkey, 60030
        • Recruiting
        • School of Medicine,Tokat Gaziosmanpasa University
        • Contact:
      • Trabzon, Turkey, 61080
        • Recruiting
        • School of Medicine,Karadeniz Technical University
        • Contact:
      • Van, Turkey, 65100
        • Recruiting
        • University of Health Sciences, Van Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

During the study period, female patients aged between 18 and 45, who present to dermatology outpatient clinics, will be examined consecutive until the number of patients designated for each study center is reached.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Women with hirsutism
Women between the ages of 18-45 with hirsutism
Women without hirsutism
Women between the ages of 18-45 without hirsutism

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ferriman-Gallwey Scoring System for Severity of Hirsutism
Time Frame: 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.
1 day (At the time of the examination)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Concomitant disease status and the risk factors
Time Frame: 1 day (At the time of the examination)
Concomitant disease status (diabetes, hyperlipidemia, hypertension, thyroid disease), hirsutism family history, history of medication causing body hair growth, 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 determined and recorded.
1 day (At the time of the examination)
Body mass indices of the participants
Time Frame: 1 day (At the time of the examination)
BMI in kg/m^2
1 day (At the time of the examination)
The presence and severity of acne in the participants
Time Frame: 1 day (At the time of the examination)
If acne is present, it will be classified as mild, moderate and severe.
1 day (At the time of the examination)
The presence and severity of androgenic alopecia in the participants
Time Frame: 1 day (At the time of the examination)
If androgenic alopecia is present, it will be classified as Ludwig 1, Ludwig 2, Ludwig 3.
1 day (At the time of the examination)
Menstrual cycle pattern of the participants
Time Frame: 1 day (At the time of the examination)
The menstrual cycle pattern of the participants will be classified as regular, oligomenorrhea, amenorrhea, polimenorrhea
1 day (At the time of the examination)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medeniyet University

Investigators

  • Principal Investigator: Filiz Cebeci Kahraman, Assoc. Prof., University of Health Sciences, Goztepe Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2020

Primary Completion (Anticipated)

September 30, 2020

Study Completion (Anticipated)

September 30, 2020

Study Registration Dates

First Submitted

February 26, 2020

First Submitted That Met QC Criteria

March 1, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 3, 2020

Last Update Submitted That Met QC Criteria

March 1, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08122018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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