The Epidemiology, Management and Comorbidities in Alopecia Areata in Czech Republic

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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The Epidemiology, Management and Associated Conditions in Alopecia Areata in Czech Republic: A University-clinic-based Cross-sectional and Cohort Study

Conditions
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Alopecia Areata, Alopecia Totalis, Alopecia Universalis, Alopecia Areata (& Ophiasis), Alopecia Barbae, Alopecia Diffuse, Autoimmune Diseases, Autoimmune Hyperthyroidism, Autoimmune Hypothyroidism, Diabetes Mellitus, Type 1, Ulcerative Colitis, Inflammatory Bowel Diseases, Crohn Disease, Rheumatoid Arthritis, Down Syndrome, Atopic Dermatitis, Atopic Asthma, Atopic Rhinitis, Vitiligo, Psoriasis, Ankylosing Spondylitis, Multiple Sclerosis, Lupus Erythematosus, COVID-19 Pandemic, Vaccine Reaction, Infections, Anemia, Pernicious

Intervention / Treatment
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* Other: Exposure of interest


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Patients with a confirmed histologic/dermatoscopic diagnosis of Alopecia areata within the study period will be included for analysis. | Other: Exposure of interest<br>* Common autoimmune and atopic conditions consist of atopic dermatitis, allergic rhinitis, asthma, Crohn's disease, ulcerative colitis, Celiac disease, Pernicious anaemia, Type 1 diabetes, Autoimmune thyroiditis (Hashimoto's thyroiditis, Grave's disease, atrophic, unspecified), rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polymyalgia rheumatica, Systemic lupus erythematosus, Sjogren syndrome, psoriasis, vitiligo, Multiple sclerosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The epidemiology of Alopecia areata | The incidence and point prevalence of Alopecia areata within the study cohort during the study period, stratified by age-group and gender | 1/1/2011-31/12/2020 | 
| The epidemiology of Alopecia areata | 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 | 1/10/2020-30/9/2021 | 
| Prevalence of atopic and autoimmune conditions in patients with Alopecia Areata | Prevalence of atopic and autoimmune conditions in patients with Alopecia Areata | 15/10/2021-14/10/2022 | 
| Treatments for alopecia areata | Assessment of various treatment modalities used for alopecia areata | 15/10/2021-14/10/2022 | 
| Safety and efficacy of treatments in alopecia areata | Assessment of various treatment modalities used for alopecia areata, efficacy, duration of treatment, reported side-effects and relapse rate after withdrawal | 15/10/2021-14/10/2022 | 
| Measurement of Thyroid stimulating hormone (TSH) | 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 | 15/10/2021-14/10/2022 | 
| Measurement of free Thyroxine (fT4) | 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 | 15/10/2021-14/10/2022 | 
| Measurement of free Triodothyronine (fT3) | 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 | 15/10/2021-14/10/2022 | 
| Measurement of Thyroid peroxidase autoantibodies (TPOAbs) | 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 | 15/10/2021-14/10/2022 | 
| Measurement of thyreoglobulin autoantibodies (TgAbs) | 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 | 15/10/2021-14/10/2022 | 
| Measurement of anti TSH receptor antibodies (TRAbs) | 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 | 15/10/2021-14/10/2022 | 
| Measurement of Vitamin D levels | 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 | 15/10/2021-14/10/2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of atopic and autoimmune conditions in the family history of patients with Alopecia Areata | Prevalence of atopic and autoimmune conditions in parents and siblings of patients with Alopecia Areata | 15/10/2021-14/10/2022 | 
| Identification and prevalence of possible exacerbating factors in patients with Alopecia Areata | Identification of possible risk factors occuring within 6 months from the onset/relapse/worsening of alopecia areata, according to patient history | 15/10/2021-14/10/2022 |