HirsutismNCT04292587
Prevalence of Hirsutism in Turkey: Data of The Dermatoendocrinology Study Group
An observational study of Hirsutism, run by Istanbul Medeniyet University at 26 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hirsutism
- How many people
- 5,861 participants
- Where
- 26 sitesTurkey (Türkiye)
- Study dates
- 3 Feb 2020to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Turkey (Türkiye)26 sites, 26 recruiting
- Recruiting
Adana City Training and Research Hospital
Adana, 01358
Tugba Yülek, M.D., tuubakarakas@hotmail.com
- Recruiting
School of Medicine, Aksaray University
Aksaray, 68000
Emel Erdal Çalıkoglu, Prof., emelerdal@hotmail.com
- Recruiting
School of Medicine, Ankara Yıldırım Beyazıt University
Ankara, 06010
Selma Emre, Prof., dr_semre@yahoo.com
- Recruiting
School of Medicine, Aydın Adnan Menderes University
Aydin, 09100
Münevver Güven, Asst. Prof., munevver.guven@adu.edu.tr
- Recruiting
Bitlis Tatvan State Hospital
Bitlis, 13200
Mustafa Kaan Tasolar, M.D., kaan_tasolar@hotmail.com
- Recruiting
School of Medicine, Uludag University
Bursa, 16285
Kenan Aydogan, Prof., aydogank@uludag.edu.tr
- Recruiting
University of Health Sciences, Gazi Yasargil Training and Research Hospital
Diyarbakır, 21070
Semahat Alp Erdal, M.D., semahatalperdal@gmail.com
- Recruiting
School of Medicine, Trakya University
Edirne, 22030
Sezgi Sarıkaya Solak, Asst. Prof., sezgisarikaya@gmail.com
- Recruiting
School of Medicine, Eskisehir Osmangazi University
Eskişehir, 26040
Hilal Kaya Erdogan, Assoc. Prof., hilalkayaerdogan@gmail.com
- Recruiting
School of Medicine, Gaziantep University
Gaziantep, 27310
Orhan Ozgöztası, Prof., ozgoztasi@gmail.com
- Recruiting
School of Medicine, Süleyman Demirel University
Isparta, 32260
Havva Hilal Ayvaz Çelik, Asst. Prof., drhhilalayvaz@gmail.com
- Recruiting
University of Health Sciences, Bakırköy Sadi Konuk Training and Research Hospital
Istanbul, 34147
Burce Can Kuru, Assoc. Prof., drburcecan@yahoo.com
- Recruiting
University of Health Sciences, Sultan 2. Abdulhamid Han Training and Research Hospital
Istanbul, 34668
Sevil Savas Erdogan, M.D., +90 554 261 68 54, doktorsevilsavas@gmail.com
- Recruiting
Istanbul Medeniyet University, Goztepe Research and Training Hospital
Istanbul, 34730
Filiz Cebeci Kahraman, Assoc. Prof., +90 537 372 47 22, cebecifiliz@yahoo.com
- Recruiting
University of Health Sciences, Umraniye Training and Research Hospital
Istanbul, 34764
İlkin Zindancı, Assoc. Prof., ilkin.dr@gmail.com
- Recruiting
Marmara University Pendik Training and Research Hospital
Istanbul, 34899
Andac Salman, Asst. Prof., asalmanitf@gmail.com
- Recruiting
School of Medicine,Izmir Katip Celebi University
Izmir, 35620
Ali Karakuzu, Prof., dr.karakuzu@gmail.com
- Recruiting
School of Medicine,Kahramanmaras Sutcu Imam University
Kahramanmaraş, 46050
Perihan Oztürk, Assoc. Prof., drperihanozturk@hotmail.com
- Recruiting
School of Medicine, Kocaeli University
Kocaeli, 41001
Dilek Bayramgürler, Prof., dbayramgurler@yahoo.com
- Recruiting
Meram School of Medicine, Necmettin Erbakan University
Konya, 42090
Arzu Ataseven, Assoc. Prof., arzuataseven@hotmail.com
- Recruiting
School of Medicine, Celal Bayar University
Manisa, 45140
Gülsüm Gencoglan, Prof., ggencoglan@gmail.com
- Recruiting
Sanlıurfa Training and Research Hospital
Sanliurfa, 63300
Isa An, M.D., is_an89@hotmail.com
- Recruiting
School of Medicine, Namık Kemal University
Tekirdağ, 59030
Hülya Albayrak, Asst. Prof., drhulyaalbayrak@gmail.com
- Recruiting
School of Medicine,Tokat Gaziosmanpasa University
Tokat Province, 60030
Zennure Takcı, Assoc. Prof., drzennure80@yahoo.com
- Recruiting
School of Medicine,Karadeniz Technical University
Trabzon, 61080
Leyla Baykal Selcuk, Asst. Prof., lb_leyla@hotmail.com
- Recruiting
University of Health Sciences, Van Training and Research Hospital
Van, 65100
Murat Oztürk, M.D., chayacholic@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Hirsutism
- Keywords
- Ferriman-Gallwey score, hirsutism, prevalence
- Medical subject headings
- Hirsutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day (At the time of the examination)
Secondary outcomes (5)
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.
Measured: 1 day (At the time of the examination)
Body mass indices of the participants
BMI in kg/m^2
Measured: 1 day (At the time of the examination)
The presence and severity of acne in the participants
If acne is present, it will be classified as mild, moderate and severe.
Measured: 1 day (At the time of the examination)
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.
Measured: 1 day (At the time of the examination)
Menstrual cycle pattern of the participants
The menstrual cycle pattern of the participants will be classified as regular, oligomenorrhea, amenorrhea, polimenorrhea
Measured: 1 day (At the time of the examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start3 Feb 2020
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HirsutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,861 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filiz Cebeci Kahraman, Istanbul Medeniyet University
- Investigators
- Filiz Cebeci Kahraman, Assoc. Prof., Principal investigator, University of Health Sciences, Goztepe Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292587
- Sponsor's protocol ID
- 08122018
- Status last verified
- Mar 2020
- First submitted
- 26 Feb 2020
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22748844Lumezi 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.
PubMed 30618534Fatemi 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.
PubMed 23056100Carmina E. Prevalence of idiopathic hirsutism. Eur J Endocrinol. 1998 Oct;139(4):421-3. doi: 10.1530/eje.0.1390421.
PubMed 9820619
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hirsutism in Turkey: Data of The Dermatoendocrinology Study Group
- ClinicalTrials.gov ID
- NCT04292587
- Acronym / sponsor ID
- 08122018
- Conditions
- Hirsutism
- Keywords
- Ferriman-Gallwey score, hirsutism, prevalence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,861 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with hirsutism | – | –Women between the ages of 18-45 with hirsutism |
| Women without hirsutism | – | –Women between the ages of 18-45 without hirsutism |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Number of Participants With Concomitant disease status and the risk factors
Time frame: 1 day (At the time of the examination)
Body mass indices of the participants
Time frame: 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)
The presence and severity of androgenic alopecia in the participants
Time frame: 1 day (At the time of the examination)
Menstrual cycle pattern of the participants
Time frame: 1 day (At the time of the examination)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Background: PubMed 22748844Li 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.
- Background: PubMed 30618534Lumezi 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.
- Background: PubMed 23056100Fatemi 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.
- Background: PubMed 9820619Carmina E. Prevalence of idiopathic hirsutism. Eur J Endocrinol. 1998 Oct;139(4):421-3. doi: 10.1530/eje.0.1390421.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filiz Cebeci Kahraman, Assoc. Prof. principal investigator
University of Health Sciences, Goztepe Training and Research Hospital
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hirsutism, run by Istanbul Medeniyet University at 26 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Filiz Cebeci Kahraman, Assoc. Prof. (+90 537 372 47 22, cebecifiliz@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ferriman-Gallwey Scoring System for Severity of Hirsutism (time frame: 1 day (At the time of the examination)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04292587, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.