Clinical trial NCT04292587: Prevalence of Hirsutism in Turkey: Data of The Dermatoendocrinology Study Group
Official title: Prevalence of Hirsutism in Turkey: Data of The Dermatoendocrinology Study Group
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hirsutism
Keywords: Ferriman-Gallwey score, hirsutism, prevalence
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 5861
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Ferriman-Gallwey Scoring System for Severity of Hirsutism
timeFrame: 1 day (At the time of the examination)
Secondary outcomes:
measure: Number of Participants With Concomitant disease status and the risk factors
timeFrame: 1 day (At the time of the examination)
measure: Body mass indices of the participants
timeFrame: 1 day (At the time of the examination)
measure: The presence and severity of acne in the participants
timeFrame: 1 day (At the time of the examination)
measure: The presence and severity of androgenic alopecia in the participants
timeFrame: 1 day (At the time of the examination)
measure: Menstrual cycle pattern of the participants
timeFrame: 1 day (At the time of the examination)
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Adana City Training and Research Hospital
city: Aksaray
country: Turkey
facility: School of Medicine, Aksaray University
city: Ankara
country: Turkey
facility: School of Medicine, Ankara Yıldırım Beyazıt University
city: Aydın
country: Turkey
facility: School of Medicine, Aydın Adnan Menderes University
city: Bitlis
country: Turkey
facility: Bitlis Tatvan State Hospital
city: Bursa
country: Turkey
facility: School of Medicine, Uludag University
city: Diyarbakır
country: Turkey
facility: University of Health Sciences, Gazi Yasargil Training and Research Hospital
city: Edirne
country: Turkey
facility: School of Medicine, Trakya University
city: Eskisehir
country: Turkey
facility: School of Medicine, Eskisehir Osmangazi University
city: Gaziantep
country: Turkey
facility: School of Medicine, Gaziantep University
city: Isparta
country: Turkey
facility: School of Medicine, Süleyman Demirel University
city: Istanbul
country: Turkey
facility: University of Health Sciences, Bakırköy Sadi Konuk Training and Research Hospital
city: Istanbul
country: Turkey
facility: University of Health Sciences, Sultan 2. Abdulhamid Han Training and Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University, Goztepe Research and Training Hospital
city: Istanbul
country: Turkey
facility: University of Health Sciences, Umraniye Training and Research Hospital
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
city: Izmir
country: Turkey
facility: School of Medicine,Izmir Katip Celebi University
city: Kahramanmaras
country: Turkey
facility: School of Medicine,Kahramanmaras Sutcu Imam University
city: Kocaeli
country: Turkey
facility: School of Medicine, Kocaeli University
city: Konya
country: Turkey
facility: Meram School of Medicine, Necmettin Erbakan University
city: Manisa
country: Turkey
facility: School of Medicine, Celal Bayar University
city: Sanlıurfa
country: Turkey
facility: Sanlıurfa Training and Research Hospital
city: Tekirdag
country: Turkey
facility: School of Medicine, Namık Kemal University
city: Tokat
country: Turkey
facility: School of Medicine,Tokat Gaziosmanpasa University
city: Trabzon
country: Turkey
facility: School of Medicine,Karadeniz Technical University
city: Van
country: Turkey
facility: University of Health Sciences, Van Training and Research Hospital
Study officials:
affiliation: University of Health Sciences, Goztepe Training and Research Hospital
name: Filiz Cebeci Kahraman, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li R, Qiao J, Yang D, Li S, Lu S, Wu X, Wei Z. Epidemiology of hirsutism among women of reproductive age in the community: a simplified scoring system. Eur J Obstet Gynecol Reprod Biol. 2012 Aug;163(2):165-9. doi: 10.1016/j.ejogrb.2012.03.023. Epub 2012 Jun 28.
citation: Lumezi BG, Berisha VL, Pupovci HL, Goci A, Hajrushi AB. Grading of hirsutism based on the Ferriman-Gallwey scoring system in Kosovar women. Postepy Dermatol Alergol. 2018 Dec;35(6):631-635. doi: 10.5114/ada.2018.77615. Epub 2018 Nov 13.
citation: Fatemi Naeini F, Najafian J, Jazebi N. Hirsutism and body mass index in a representative sample of Iranian people. ARYA Atheroscler. 2012 Spring;8(1):43-54.
citation: Carmina E. Prevalence of idiopathic hirsutism. Eur J Endocrinol. 1998 Oct;139(4):421-3. doi: 10.1530/eje.0.1390421.