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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05098600
• Other study ID #: NKS1001
• Status: Completed
• Start date: October 15, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: February 2023
• Source: Faculty Hospital Kralovske Vinohrady
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: December 20, 2022
• Est. primary completion date: October 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Alopecia Totalis
• Alopecia Universalis
• Ankylosing Spondylitis
• Atopic Asthma
• Atopic Dermatitis
• Autoimmune Diseases
• COVID-19
• COVID-19 Pandemic
• Crohn Disease
• Dermatitis
• Diabetes Mellitus, Type 1
• Down Syndrome
• Graves Disease
• Hyperthyroidism
• Hypothyroidism
• Infections
• Inflammatory Bowel Diseases
• Lupus Erythematosus
• Multiple Sclerosis
• Psoriasis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing
• Ulcerative Colitis
• Vaccine Reaction
• Vitiligo

Intervention

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

Locations

Country	Name	City	State
Czechia	Teaching Hospital of Royal Vineguards	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Faculty Hospital Kralovske Vinohrady

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

Harries M, Macbeth AE, Holmes S, Chiu WS, Gallardo WR, Nijher M, de Lusignan S, Tziotzios C, Messenger AG. The epidemiology of alopecia areata: a population-based cohort study in UK primary care. Br J Dermatol. 2022 Feb;186(2):257-265. doi: 10.1111/bjd.20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Treatments for alopecia areata	Assessment of various treatment modalities used for alopecia areata	15/10/2021-14/10/2022
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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