An observational study in Alopecia Areata, Alopecia Totalis and Alopecia Universalis, sponsored by Faculty Hospital Kralovske Vinohrady. Completed at 1 site in Czechia. Per ClinicalTrials.gov, last updated 2024-12-03.
Sponsored by Faculty Hospital Kralovske Vinohrady · Observational
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.
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
220 studies on the registry are indexed under Alopecia Areata; 61 are open to participants now.
This study's enrollment of 123 is below the median of 370 across 39 observational studies indexed under Alopecia Areata.
Browse Alopecia Areata studies →Faculty Hospital Kralovske Vinohrady is the lead sponsor of 30 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult and children patients with a dermatologic condition between 1/1/2011-31/12/2020 and for the second study, adults and children with first-onset/relapsing/persistent-untreated alopecia areata visiting our clinic between 15/10/2021 and 14/10/2022 who sign informed consent are eligible.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with a confirmed histologic/dermatoscopic diagnosis of Alopecia areata within the study period will be included for analysis.
Other: Exposure of interest
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
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
Time frame: 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
Time frame: 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
Time frame: 15/10/2021-14/10/2022
Treatments for alopecia areata
Assessment of various treatment modalities used for alopecia areata
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 15/10/2021-14/10/2022
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
Time frame: 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
Time frame: 15/10/2021-14/10/2022
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Oct 2021 to primary completion in Oct 2022, 11 months.
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Faculty Hospital Kralovske Vinohrady