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

Completed

• Conditions: Autoimmune Hypothyroidism; Diabetes Mellitus, Type 1; Ulcerative Colitis; Inflammatory Bowel Diseases; Down Syndrome; Psoriasis; Ankylosing Spondylitis; Atopic Asthma; Lupus Erythematosus; Infections
• Interventions: Other: Exposure of interest

• Registration Number: NCT05098600
• Lead Sponsor: Faculty Hospital Kralovske Vinohrady

Brief Summary

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

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

Study Timeline

• Study Start: 2021-10-15
• Study First Submitted: 2021-10-16
• Study First Submitted QC: 2021-10-16
• Study First Posted: 2021-10-28
• Primary Completion: 2022-10-14
• Study Completion: 2022-12-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Exposure of interest	Patients with a confirmed histologic/dermatoscopic diagnosis of Alopecia areata within the study period will be included for analysis.

Primary Outcome Measures

Name	Time	Method
Measurement of free Thyroxine (fT4)	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)	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	15/10/2021-14/10/2022	Assessment of various treatment modalities used for alopecia areata
Safety and efficacy of treatments in alopecia areata	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)	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)	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)	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	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	15/10/2021-14/10/2022	Prevalence of atopic and autoimmune conditions in patients with Alopecia Areata
Measurement of free Triodothyronine (fT3)	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	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Teaching Hospital of Royal Vineguards; 🇨🇿 Prague, Czechia