Clinical trial NCT05098600: The Epidemiology, Management and Comorbidities in Alopecia Areata in Czech Republic
Official title: The Epidemiology, Management and Associated Conditions in Alopecia Areata in Czech Republic: A University-clinic-based Cross-sectional and Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: Faculty Hospital Kralovske Vinohrady
Sponsor class: OTHER_GOV
First posted: 2021-10-28
Enrollment: 123
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: The epidemiology of Alopecia areata
timeFrame: 1/1/2011-31/12/2020
measure: The epidemiology of Alopecia areata
timeFrame: 1/10/2020-30/9/2021
measure: Prevalence of atopic and autoimmune conditions in patients with Alopecia Areata
timeFrame: 15/10/2021-14/10/2022
measure: Treatments for alopecia areata
timeFrame: 15/10/2021-14/10/2022
measure: Safety and efficacy of treatments in alopecia areata
timeFrame: 15/10/2021-14/10/2022
measure: Measurement of Thyroid stimulating hormone (TSH)
timeFrame: 15/10/2021-14/10/2022
measure: Measurement of free Thyroxine (fT4)
timeFrame: 15/10/2021-14/10/2022
measure: Measurement of free Triodothyronine (fT3)
timeFrame: 15/10/2021-14/10/2022
measure: Measurement of Thyroid peroxidase autoantibodies (TPOAbs)
timeFrame: 15/10/2021-14/10/2022
measure: Measurement of thyreoglobulin autoantibodies (TgAbs)
timeFrame: 15/10/2021-14/10/2022
measure: Measurement of anti TSH receptor antibodies (TRAbs)
timeFrame: 15/10/2021-14/10/2022
measure: Measurement of Vitamin D levels
timeFrame: 15/10/2021-14/10/2022
Secondary outcomes:
measure: Prevalence of atopic and autoimmune conditions in the family history of patients with Alopecia Areata
timeFrame: 15/10/2021-14/10/2022
measure: Identification and prevalence of possible exacerbating factors in patients with Alopecia Areata
timeFrame: 15/10/2021-14/10/2022
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Teaching Hospital of Royal Vineguards
Study officials:
References: