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NCT Number: NCT05098600

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

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.

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Key information

Conditions

Alopecia Areata Abnormalities, Multiple Alopecia Alopecia Areata (& Ophiasis) Alopecia Barbae Alopecia Diffuse Alopecia Totalis Alopecia Universalis Anemia Anemia, Macrocytic Anemia, Megaloblastic Anemia, Pernicious Ankylosing Spondylitis Ankylosis Arthritis Arthritis, Rheumatoid Atopic Asthma Atopic Dermatitis Atopic Rhinitis Autoimmune Diseases Autoimmune Diseases of the Nervous System Autoimmune Hyperthyroidism Autoimmune Hypothyroidism Avitaminosis Axial Spondyloarthritis Bone Diseases COVID-19 COVID-19 Pandemic Chromosome Disorders Colitis Colitis, Ulcerative Colonic Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Coronaviridae Infections Coronavirus Infections Crohn Disease Deficiency Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Dermatitis Dermatitis, Atopic Diabetes Mellitus Diabetes Mellitus, Type 1 Diffuse alopecia Digestive System Diseases Down Syndrome Endocrine System Diseases Exophthalmos Eye Diseases Gastroenteritis Gastrointestinal Diseases Genetic Diseases, Inborn Glucose Metabolism Disorders Goiter Graves Disease Hair Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Hyperthyroidism Hypopigmentation Hypothyroidism, Autoimmune Hypotrichosis Immune System Diseases Infections Inflammatory Bowel Diseases Intellectual Disability Intestinal Diseases Joint Diseases Lung Diseases Lupus Erythematosus Malnutrition Metabolic Diseases Multiple Sclerosis Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nidovirales Infections Nose Diseases Nutrition Disorders Nutritional and Metabolic Diseases Orbital Diseases Otorhinolaryngologic Diseases Pigmentation Disorders Pneumonia Pneumonia, Viral Psoriasis RNA Virus Infections Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rheumatic Diseases Rheumatoid Arthritis Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Thyroid Diseases Ulcerative Colitis Vaccine Reaction Virus Diseases Vitamin B 12 Deficiency Vitamin B Deficiency Vitiligo

Sex eligibility

All sexes

Study type

Observational

Primary location

Teaching Hospital of Royal Vineguards

Prague, 100 00, Czechia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exposure of interest

Other

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

Primary outcomes

  1. The epidemiology of Alopecia areata

    Time frame: 1/1/2011-31/12/2020

    The incidence and point prevalence of Alopecia areata within the study cohort during the study period, stratified by age-group and gender

  2. The epidemiology of Alopecia areata

    Time frame: 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

  3. Prevalence of atopic and autoimmune conditions in patients with Alopecia Areata

    Time frame: 15/10/2021-14/10/2022

    Prevalence of atopic and autoimmune conditions in patients with Alopecia Areata

  4. Treatments for alopecia areata

    Time frame: 15/10/2021-14/10/2022

    Assessment of various treatment modalities used for alopecia areata

  5. Safety and efficacy of treatments in alopecia areata

    Time frame: 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

  6. Measurement of Thyroid stimulating hormone (TSH)

    Time frame: 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

  7. Measurement of free Thyroxine (fT4)

    Time frame: 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

  8. Measurement of free Triodothyronine (fT3)

    Time frame: 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

  9. Measurement of Thyroid peroxidase autoantibodies (TPOAbs)

    Time frame: 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

  10. Measurement of thyreoglobulin autoantibodies (TgAbs)

    Time frame: 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

  11. Measurement of anti TSH receptor antibodies (TRAbs)

    Time frame: 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

  12. Measurement of Vitamin D levels

    Time frame: 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 outcomes

  1. Prevalence of atopic and autoimmune conditions in the family history of patients with Alopecia Areata

    Time frame: 15/10/2021-14/10/2022

    Prevalence of atopic and autoimmune conditions in parents and siblings of patients with Alopecia Areata

  2. Identification and prevalence of possible exacerbating factors in patients with Alopecia Areata

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Faculty Hospital Kralovske Vinohrady

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 28, 2021
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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