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

Hirsutism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04292587
• Other study ID #: 08122018
• Status: Recruiting
• Start date: February 3, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: March 2020
• Source: Istanbul Medeniyet University
• Contact: Filiz Cebeci Kahraman, Assoc. Prof.
• Phone: +90 537 372 47 22
• Email: cebecifiliz[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5861
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hirsutism

Locations

Country	Name	City	State
Turkey	Adana City Training and Research Hospital	Adana
Turkey	School of Medicine, Aksaray University	Aksaray
Turkey	School of Medicine, Ankara Yildirim Beyazit University	Ankara
Turkey	School of Medicine, Aydin Adnan Menderes University	Aydin
Turkey	Bitlis Tatvan State Hospital	Bitlis
Turkey	School of Medicine, Uludag University	Bursa
Turkey	University of Health Sciences, Gazi Yasargil Training and Research Hospital	Diyarbakir
Turkey	School of Medicine, Trakya University	Edirne
Turkey	School of Medicine, Eskisehir Osmangazi University	Eskisehir
Turkey	School of Medicine, Gaziantep University	Gaziantep
Turkey	School of Medicine, Süleyman Demirel University	Isparta
Turkey	Istanbul Medeniyet University, Goztepe Research and Training Hospital	Istanbul
Turkey	Marmara University Pendik Training and Research Hospital	Istanbul
Turkey	University of Health Sciences, Bakirköy Sadi Konuk Training and Research Hospital	Istanbul
Turkey	University of Health Sciences, Sultan 2. Abdulhamid Han Training and Research Hospital	Istanbul
Turkey	University of Health Sciences, Umraniye Training and Research Hospital	Istanbul
Turkey	School of Medicine,Izmir Katip Celebi University	Izmir
Turkey	School of Medicine,Kahramanmaras Sutcu Imam University	Kahramanmaras
Turkey	School of Medicine, Kocaeli University	Kocaeli
Turkey	Meram School of Medicine, Necmettin Erbakan University	Konya
Turkey	School of Medicine, Celal Bayar University	Manisa
Turkey	Sanliurfa Training and Research Hospital	Sanliurfa
Turkey	School of Medicine, Namik Kemal University	Tekirdag
Turkey	School of Medicine,Tokat Gaziosmanpasa University	Tokat
Turkey	School of Medicine,Karadeniz Technical University	Trabzon
Turkey	University of Health Sciences, Van Training and Research Hospital	Van

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Carmina E. Prevalence of idiopathic hirsutism. Eur J Endocrinol. 1998 Oct;139(4):421-3. — View 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. — View 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. — View Citation

Lumezi BG, Berisha VL, Pupovci HL, Goçi 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Ferriman-Gallwey Scoring System for Severity of Hirsutism	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	Number of Participants With Concomitant disease status and the risk factors	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)
Secondary	Body mass indices of the participants	BMI in kg/m^2	1 day (At the time of the examination)
Secondary	The presence and severity of acne in the participants	If acne is present, it will be classified as mild, moderate and severe.	1 day (At the time of the examination)
Secondary	The presence and severity of androgenic alopecia in the participants	If androgenic alopecia is present, it will be classified as Ludwig 1, Ludwig 2, Ludwig 3.	1 day (At the time of the examination)
Secondary	Menstrual cycle pattern of the participants	The menstrual cycle pattern of the participants will be classified as regular, oligomenorrhea, amenorrhea, polimenorrhea	1 day (At the time of the examination)