The Epidemiology, Management and Associated Conditions in Alopecia Areata in Czech Republic: A University-clinic-based Cross-sectional and Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Measurement of free Thyroxine (fT4)
研究概览
简要总结
The study series consists of three studies with the aim to assess the incidence, prevalence, risk factors, comorbidities and management of patients with alopecia areata in Czech Republic based on the patients and registry of a dermatology clinic of a metropolitan hospital.
详细描述
The first study will aim to identify the incidence and prevalence of alopecia areata in the dermatology clinic of a metropolitan teaching hospital between 1/1/2011 and 31/12/2020
The second study will assess (1) the epidemiology of autoimmune and atopic diseases in patients with alopecia areata, (2) the presence of possible risk factors responsible for the onset/relapse/exacerbation of alopecia areata, (3) the levels of vitamin D and various autoantibodies,particularly thyroid autoantibodies and (4) the variety, duration, efficacy and safety profile of treatment modalities used in our hospital for the management of alopecia areata from 15/10/2021 to 14/10/2022.
The third study will monitor the monthly oscillations of vitamin D and thyroid-autoantibodies of patients with new-onset/relasping or exacerbating alopecia areata for six months, between 15/10/2021-14/10/2022 in order to observe if changes in levels of vitamin D and thyroid-antiantibodies are associated with severity and prognosis (worsening or improvement) of alopecia areata
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients visiting our clinic with a dermatologic condition between 1/1/2011-31/12/2020
- •For the second study, only patients with histologic/dermatoscopic diagnosis of new-onset/relapsing/peristent-untreated alopecia areata, presenting to our clinic between 15/10/2021-14/10/2022 are included.
排除标准
- •For the second study patients with other alopecias, patients denying data sharing despite signing the informed concent and presenting outside the study period are excluded.
- •For the third study, patients with other types of alopecia, as well as those who signed the informed consent but refused to share their data or undergo blood tests at our hospital, and those who did not visit our outpatient department at least once a month for the required duration, were excluded.
结局指标
主要结局
Measurement of free Thyroxine (fT4)
时间窗: 15/10/2021-14/10/2022
Measurement of fT4 on first visit and once a month for 6 months. Normal values for adults 11.50-22.70 pmol/l according to our laboratory. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
Measurement of Thyroid peroxidase autoantibodies (TPOAbs)
时间窗: 15/10/2021-14/10/2022
Measurement of TPOAbs on first visit and once a month for 6 months. Normal values for adults \<60 kU/l according to our laboratorypmol/l. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
Treatments for alopecia areata
时间窗: 15/10/2021-14/10/2022
Assessment of various treatment modalities used for alopecia areata
Safety and efficacy of treatments in alopecia areata
时间窗: 15/10/2021-14/10/2022
Assessment of various treatment modalities used for alopecia areata, efficacy, duration of treatment, reported side-effects and relapse rate after withdrawal
Measurement of Thyroid stimulating hormone (TSH)
时间窗: 15/10/2021-14/10/2022
Measurement of TSH on first visit and once a month for 6 months. Normal values for adults 0.550-4.780 mu/l according to our laboratory. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
Measurement of thyreoglobulin autoantibodies (TgAbs)
时间窗: 15/10/2021-14/10/2022
Measurement of TgAbs on first visit and once a month for 6 months. Normal values for adults \<4.5 kIUl/l according to our laboratory. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
Measurement of anti TSH receptor antibodies (TRAbs)
时间窗: 15/10/2021-14/10/2022
Measurement of TRAbs on first visit and once a month for 6 months. Normal values for adults \<1.22 Ul/l according to our laboratory. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
The epidemiology of Alopecia areata
时间窗: 1/10/2020-30/9/2021
The incidence and point prevalence of Alopecia areata (totalis, universalis, ophiasis, sisaipho, reticularis, diffuse, barbae) within the study cohort during the study period, stratified by age-group and gender
Prevalence of atopic and autoimmune conditions in patients with Alopecia Areata
时间窗: 15/10/2021-14/10/2022
Prevalence of atopic and autoimmune conditions in patients with Alopecia Areata
Measurement of free Triodothyronine (fT3)
时间窗: 15/10/2021-14/10/2022
Measurement of fT3 on first visit and once a month for 6 months. Normal values for adults 3.50-6.50 pmol/l according to our laboratory. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
Measurement of Vitamin D levels
时间窗: 15/10/2021-14/10/2022
Measurement of Vitamin D levels on first visit and once a month for 6 months. Normal values for adults are 75.0-250.0 nmol/l acording to our laboratory. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
次要结局
- Identification and prevalence of possible exacerbating factors in patients with Alopecia Areata(15/10/2021-14/10/2022)
- Prevalence of atopic and autoimmune conditions in the family history of patients with Alopecia Areata(15/10/2021-14/10/2022)
研究者
Athanasios J. Stefanis
Prinicipal Investigator
Faculty Hospital Kralovske Vinohrady