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

Sponsor

Faculty Hospital Kralovske Vinohrady (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05098600

Collaborator

(none)

1,000

Enrollment

Location

2.9

Anticipated Duration (Months)

349.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study series consists of two 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 registry of a dermatology clinic of a metropolitan hospital.

Condition or Disease	Intervention/Treatment	Phase
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	Other: Exposure of interest

Detailed Description

The first study will aim to identify the epidemiology of alopecia areata in the dermatology clinic of a metropolitan teaching hospital and the variety of treatments used in our clinic between 1/1/2011 and 31/12/2020

The second study will assess (1) the epidemiology of autoimmune diseases and other conditions in patients with alopecia areata, (2) the presence of possible risk factors responsible for the onset/relapse/exacerbation of alopecia areata and (3) the variety, duration, efficacy and safety profile of treatment modalities used in our hospital for the management of alopecia areata from 1/10/2020 to 30/9/2021.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 15, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Jan 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Cases 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

Arm

Intervention/Treatment

Cases

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

Outcome Measures

Primary Outcome Measures

The epidemiology of Alopecia areata [1/1/2010-31/12/2020]
The incidence and point prevalence of Alopecia areata within the study cohort during the study period, stratified by age-group and gender
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 [1/10/2020-30/9/2021]
Prevalence of atopic and autoimmune conditions in patients with Alopecia Areata
Treatments for alopecia areata [1/1/2010-31/12/2020]
Assessment of various treatment modalities used for alopecia areata
Safety and efficacy of treatments in alopecia areata [1/10/2020-30/9/2021]
Assessment of various treatment modalities used for alopecia areata, efficacy, duration of treatment, reported side-effects and relapse rate after withdrawal

Secondary Outcome Measures

Prevalence of atopic and autoimmune conditions in the family history of patients with Alopecia Areata [1/10/2020-30/9/2021]
Prevalence of atopic and autoimmune conditions in parents and siblings of patients with Alopecia Areata
Identification and prevalence of possible exacerbating factors in patients with Alopecia Areata [1/10/2020-30/9/2021]
Identification of possible risk factors occuring within 6 months from the onset/relapse/worsening of alopecia areata, according to patient history

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients visiting our clinic with a dermatologic condition between 1/1/2010-31/12/2020
For the second study, only patients with histologic/dermatoscopic diagnosis of alopecia areata, presenting to our clinic between 1/10/2020-30/9/2021 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.