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

NCT05098600 | Completed

• 1 other identifier: NKS1001
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• Treatments for alopecia areata

  Assessment of various treatment modalities used for alopecia areata

  15/10/2021-14/10/2022

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

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

  15/10/2021-14/10/2022

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

  15/10/2021-14/10/2022

Study Arms (1)

Cases

Patients with a confirmed histologic/dermatoscopic diagnosis of Alopecia areata within the study period will be included for analysis.

Other: Exposure of interest

Interventions

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

Cases

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculty Hospital Kralovske Vinohrady: lead

Study Sites (1)

Teaching Hospital of Royal Vineguards

Prague, 100 00, Czechia

Location

MeSH Terms

Conditions

Alopecia Areata; Alopecia universalis; Diffuse alopecia; Autoimmune Diseases; Graves Disease; Hypothyroidism, Autoimmune; Diabetes Mellitus, Type 1; Colitis, Ulcerative; Inflammatory Bowel Diseases; Crohn Disease; Arthritis, Rheumatoid; Down Syndrome; Dermatitis, Atopic; Rhinitis, Allergic, Perennial; Vitiligo; Psoriasis; Spondylitis, Ankylosing; Multiple Sclerosis; COVID-19; Infections; Anemia, Pernicious

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Skin Diseases, Genetic; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypopigmentation; Pigmentation Disorders; Skin Diseases, Papulosquamous; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Anemia, Megaloblastic; Anemia, Macrocytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Vitamin B 12 Deficiency; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: October 16, 2021
• First Posted: October 28, 2021
• Study Start: October 15, 2021
• Primary Completion: October 14, 2022
• Study Completion: December 20, 2022
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

CZ (1)