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

Sponsor
Istanbul Medeniyet University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04292587
Collaborator
(none)
5,861
26
7.9
225.4
28.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    5861 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prevalence of Hirsutism in Turkey: Data of The Dermatoendocrinology Study Group
    Actual Study Start Date :
    Feb 3, 2020
    Anticipated Primary Completion Date :
    Sep 30, 2020
    Anticipated Study Completion Date :
    Sep 30, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Women with hirsutism

    Women between the ages of 18-45 with hirsutism

    Women without hirsutism

    Women between the ages of 18-45 without hirsutism

    Outcome Measures

    Primary Outcome Measures

    1. Modified Ferriman-Gallwey Scoring System for Severity of Hirsutism [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.

    Secondary Outcome Measures

    1. Number of Participants With Concomitant disease status and the risk factors [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.

    2. Body mass indices of the participants [1 day (At the time of the examination)]

      BMI in kg/m^2

    3. The presence and severity of acne in the participants [1 day (At the time of the examination)]

      If acne is present, it will be classified as mild, moderate and severe.

    4. The presence and severity of androgenic alopecia in the participants [1 day (At the time of the examination)]

      If androgenic alopecia is present, it will be classified as Ludwig 1, Ludwig 2, Ludwig 3.

    5. Menstrual cycle pattern of the participants [1 day (At the time of the examination)]

      The menstrual cycle pattern of the participants will be classified as regular, oligomenorrhea, amenorrhea, polimenorrhea

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Adana City Training and Research Hospital Adana Turkey 01358
    2 School of Medicine, Aksaray University Aksaray Turkey 68000
    3 School of Medicine, Ankara Yıldırım Beyazıt University Ankara Turkey 06010
    4 School of Medicine, Aydın Adnan Menderes University Aydın Turkey 09100
    5 Bitlis Tatvan State Hospital Bitlis Turkey 13200
    6 School of Medicine, Uludag University Bursa Turkey 16285
    7 University of Health Sciences, Gazi Yasargil Training and Research Hospital Diyarbakır Turkey 21070
    8 School of Medicine, Trakya University Edirne Turkey 22030
    9 School of Medicine, Eskisehir Osmangazi University Eskisehir Turkey 26040
    10 School of Medicine, Gaziantep University Gaziantep Turkey 27310
    11 School of Medicine, Süleyman Demirel University Isparta Turkey 32260
    12 University of Health Sciences, Bakırköy Sadi Konuk Training and Research Hospital Istanbul Turkey 34147
    13 University of Health Sciences, Sultan 2. Abdulhamid Han Training and Research Hospital Istanbul Turkey 34668
    14 Istanbul Medeniyet University, Goztepe Research and Training Hospital Istanbul Turkey 34730
    15 University of Health Sciences, Umraniye Training and Research Hospital Istanbul Turkey 34764
    16 Marmara University Pendik Training and Research Hospital Istanbul Turkey 34899
    17 School of Medicine,Izmir Katip Celebi University Izmir Turkey 35620
    18 School of Medicine,Kahramanmaras Sutcu Imam University Kahramanmaras Turkey 46050
    19 School of Medicine, Kocaeli University Kocaeli Turkey 41001
    20 Meram School of Medicine, Necmettin Erbakan University Konya Turkey 42090
    21 School of Medicine, Celal Bayar University Manisa Turkey 45140
    22 Sanlıurfa Training and Research Hospital Sanlıurfa Turkey 63300
    23 School of Medicine, Namık Kemal University Tekirdag Turkey 59030
    24 School of Medicine,Tokat Gaziosmanpasa University Tokat Turkey 60030
    25 School of Medicine,Karadeniz Technical University Trabzon Turkey 61080
    26 University of Health Sciences, Van Training and Research Hospital Van Turkey 65100

    Sponsors and Collaborators

    • Istanbul Medeniyet University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Filiz Cebeci Kahraman, Associate Professor, Istanbul Medeniyet University
    ClinicalTrials.gov Identifier:
    NCT04292587
    Other Study ID Numbers:
    • 08122018
    First Posted:
    Mar 3, 2020
    Last Update Posted:
    Mar 3, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Filiz Cebeci Kahraman, Associate Professor, Istanbul Medeniyet University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 3, 2020