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NCT Number: NCT04239521

The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata

This study series consists of four related studies and aims to explore and describe many important elements of alopecia areata over three key areas: (1) the current epidemiology of alopecia areata, (2) the prevalence and incidence of psychiatric co-morbidities in people with alopecia areata, (3) the prevalence and incidence of autoimmune and atopic conditions in people with alopecia areata, and (4) the incidence of common infections in people with alopecia areata.

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Key information

Conditions

Alopecia Areata Acute Bronchitis Allergic Rhinitis Alopecia Anemia Anemia, Macrocytic Anemia, Megaloblastic Anemia, Pernicious Ankylosing Spondylitis Ankylosis Anxiety Disorders Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Asthma Atopic Dermatitis Autoimmune Diseases Autoimmune Diseases of the Nervous System Avitaminosis Axial Spondyloarthritis Behavior Behavioral Symptoms Bone Diseases Bronchial Diseases Bronchitis Celiac Disease Cellulitis Colitis Colitis, Ulcerative Colonic Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Crohn Disease DNA Virus Infections Deficiency Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Depression Depressive Disorder Depressive Episode Dermatitis Dermatitis, Atopic Diabetes Mellitus Diabetes Mellitus, Type 1 Digestive System Diseases Dry Eye Syndromes Endocrine System Diseases Exophthalmos Eye Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Gastrointestinal Infection Genetic Diseases, Inborn Genital Infection Glucose Metabolism Disorders Goiter Graves Disease Hair Diseases Hashimoto Disease Hashimoto Thyroiditis Hematologic Diseases Hemic and Lymphatic Diseases Herpes Simplex Herpes Zoster Herpesviridae Infections Hypersensitivity Hypersensitivity, Immediate Hyperthyroidism Hypopigmentation Hypotrichosis Immune System Diseases Infection Infection Viral Infections Inflammation Inflammatory Bowel Diseases Influenza Influenza, Human Intestinal Diseases Joint Diseases Lacrimal Apparatus Diseases Lower Resp Tract Infection Lung Diseases Lung Diseases, Obstructive Lupus Erythematosus, Systemic Malabsorption Syndromes Male Urogenital Diseases Malnutrition Mental Disorders Metabolic Diseases Mood Disorders Mouth Diseases Multiple Sclerosis Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Nose Diseases Nutrition Disorders Nutritional and Metabolic Diseases Orbital Diseases Orthomyxoviridae Infections Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pernicious Anemia Pigmentation Disorders Pneumonia Polymyalgia Rheumatica Psoriasis Psoriatic Arthritis RNA Virus Infections Recurrent Depressive Disorder Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rheumatic Diseases Rheumatoid Arthritis Rhinitis Rhinitis, Allergic Salivary Gland Diseases Sjogren's Syndrome Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin Diseases, Infectious Skin Diseases, Papulosquamous Skin Diseases, Viral Skin Infection Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Stomatognathic Diseases Suppuration Systemic Lupus Erythematosus Thyroid Diseases Thyroiditis Thyroiditis, Autoimmune Type 1 Diabetes Ulcerative Colitis Upper Respiratory Tract Infection Urinary Tract Infections Urogenital Diseases Urologic Diseases Varicella Zoster Virus Infection Virus Diseases Vitamin B 12 Deficiency Vitamin B Deficiency Vitiligo Xerostomia

Sex eligibility

All sexes

Study type

Observational

Primary location

Momentum Data Ltd

London, WC1X 8QT, United Kingdom

About this study

The overall purpose of the first study (Study 1) is to describe the epidemiology of Alopecia areata (AA) and to assess the current level of primary care service utilisation and management patterns associated with patients diagnosed with AA.

The overall purpose of the second study (study 2) is to assess the prevalence and incidence of mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult patients diagnosed with AA relative to a control population of patients without a diagnosis of AA. In addition, the study will determine both the treatment, 'sick day' and unemployment burden. Treatment burden comprises that of medications and psychological interventions used to treat mental health conditions in adult patients diagnosed with Alopecia areata.

The overall purpose of the third study (Study 3) is to assess the prevalence and incidence of atopic and autoimmune conditions in adult patients diagnosed with AA relative to a control population of patients without AA.

The overall purpose of the fourth study (Study 4) is to assess the incidence of common infections in adult patients diagnosed with AA relative to a control population of patients without AA.

Who can participate

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

Inclusion criteria

  • Patients contributing to Royal College of General Practitioners Research and Surveillance Centre(RCGP RCS) primary care database between January 1, 2009 and December 31, 2018, will be eligible for inclusion.
  • Only patients aged ≥18 will be eligible for studies 2 and 3.
  • Only patients aged ≥ 18 and ≤ 65 will be included in the unemployment and sick day analysis (study 2)

Exclusion criteria

  • People with the alternative non-AA diagnoses.
  • People with AA diagnosis within 6 months of registration.
  • People with less than 1 year of follow up available

Treatment and study plan

Exposure of interest (studies 2 & 3).

Other

Common mental health conditions consist of depressive episodes, recurrent depressive disorder and anxiety disorder Atopic conditions consist of Atopic dermatitis, allergic rhinitis, asthma Autoimmune conditions consist of Crohn's disease, ulcerative colitis, Coeliac disease, Pernicious anaemia, Type 1 diabetes, Hashimoto's thyroiditis, Grave's disease, Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Systemic lupus erythematosus, polymyalgia rheumatica, Sjögren's syndrome, Psoriasis, vitiligo, Multiple sclerosis

Primary outcomes

  1. Study 1: The incidence of Alopecia Areata

    Time frame: Overall during 2009-2018 inclusive

    The incidence of Alopecia areata within the study cohort during the study period

  2. Study 1: The incidence of Alopecia Areata stratified by sociodemographic factors

    Time frame: Overall during 2009-2018 inclusive

    This will comprise of the incidence of Alopecia Areata over the study period, by age group, gender, ethnicity, and Social Economic Status.

  3. Study 1:The annual rate of primary care visits for people with Alopecia Areata.

    Time frame: Within one year of diagnosis of Alopecia Areata

    The annual rate of visits to primary care for any reason within one year of diagnosis.

  4. Study 1: Secondary care dermatology service utilisation

    Time frame: Within one year of diagnosis of Alopecia Areata

    The percent of people reviewed in secondary care dermatology services within one year of diagnosis of Alopecia Areata

  5. Study 2: The prevalence of common mental health conditions in adult patients diagnosed with Alopecia Areata at the time of diagnosis

    Time frame: At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive

    Prevalence of common mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult patients diagnosed with Alopecia Areata in a contemporary real-world population compared with matched controls.

  6. Study 2: Describe the incidence of common mental health conditions in adult patients with Alopecia Areata

    Time frame: Within two years of diagnosis of Alopecia Areata

    Incidence of common mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.

  7. Study 2: Describe the mental health medication treatment burden of adult patients diagnosed with Alopecia Areata.

    Time frame: Within two years of diagnosis of Alopecia Areata

    This will comprise of the number of medications used to treat mental health conditions in patients diagnoses with Alopecia Areata. Antidepressant medication classes to be examined comprise; selective serotonin reuptake inhibitors and related medications (serotonin and norepinephrine reuptake inhibitors (SNRIs)), tricyclic antidepressants and related medications (tetracyclic antidepressant), and monoamine oxidase inhibitors. Anxiolytic medications to be examined comprise all benzodiazepines and other related medications indicated for use in anxiety states.

  8. Study 2: Number of patients diagnosed with Alopecia Areata receiving mental health psychological intervention.

    Time frame: Within two years of diagnosis of Alopecia Areata

    This will comprise of the number of psychological interventions used to treat mental health conditions in patients diagnoses with Alopecia Areata. Psychological interventions comprise of counselling, Cognitive Behavioural Therapy, and psychotherapy.

  9. Study 3: Describe the prevalence of atopic and autoimmune conditions in adult patients diagnosed with Alopecia Areata at the time of diagnosis

    Time frame: At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive

    Prevalence of atopic and autoimmune conditions in adult patients diagnosed with Alopecia Areata in a contemporary real-world population at diagnosis compared with matched controls.

  10. Study 3: Describe the incidence of atopic and autoimmune conditions in adult patients with Alopecia Areata.

    Time frame: Within five years of Alopecia Areata diagnosis

    Incidence of atopic and autoimmune conditions in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.

  11. Study 4: The incidence of a composite of common infections in adult patients with Alopecia Areata

    Time frame: Within five years of Alopecia Areata diagnosis

    Incidence of a composite of any common infection (composite comprising a diagnosis of: upper and lower respiratory tract infection, pneumonia, acute bronchitis, influenza, skin infection, urinary tract infection, genital infections, gastrointestinal infection, herpes simplex and herpes zoster) in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.

  12. Study 4: The incidence of a composite of viral infections in adult patients with Alopecia Areata

    Time frame: Within five years of Alopecia Areata diagnosis

    Incidence of a composite of any viral infection (composite comprising a diagnosis of: influenza, herpes simplex and herpes zoster infections, bronchitis, and any upper respiratory tract infections specifically coded as being viral) in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.

Secondary outcomes

  1. Study 1: Adjusted incidence rate ratios of Alopecia Areata within England by geographic region.

    Time frame: Overall during 2009-2018 inclusive

    By region across England.

  2. Study 2: Prevalence (percentage) of common mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder), by socio-demographic factors, in adult patients diagnosed with Alopecia Areata.

    Time frame: At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive

    By age group, gender, ethnicity, and Social Economic Status.

  3. Study 2: Describe the burden of 'sick days' in adult patients diagnosed with Alopecia Areata relating to mental health conditions.

    Time frame: Within one year of diagnosis of Alopecia Areata

    Sick days will be indicated by the issuing of Med 3 certification from primary care (Statement of Fitness for Work) certification.

  4. Study 2: Describe the prevalence of unemployment in adult patients diagnosed with Alopecia Areata.

    Time frame: Within one year of diagnosis of Alopecia Areata

    Unemployment will be identified using Read codes relating to unemployment recorded in the clinical record or the issuing of an Incapacity Benefit (IB113) or Employment and Support Allowance (ESA113) form.

  5. Study 4: The incidence of upper respiratory tract infection in adult patients with Alopecia Areata

    Time frame: Within five years of Alopecia Areata diagnosis

    Incidence of any recorded diagnosis of upper respiratory tract infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.

  6. Study 4: The incidence of lower respiratory tract infection in adult patients with Alopecia Areata

    Time frame: Within five years of Alopecia Areata diagnosis

    Incidence of any recorded diagnosis of lower respiratory tract infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.

  7. Study 4: The incidence of influenza infection in adult patients with Alopecia Areata

    Time frame: Within five years of Alopecia Areata diagnosis

    Incidence of any recorded diagnosis of influenza or influenza-like illness (where direct swab confirmed diagnosis is not performed) in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.

  8. Study 4: The incidence of acute bronchitis in adult patients with Alopecia Areata

    Time frame: Within five years of Alopecia Areata diagnosis

    Incidence of any recorded diagnosis of acute bronchitis in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.

  9. Study 4: The incidence of pneumonia in adult patients with Alopecia Areata

    Time frame: Within five years of Alopecia Areata diagnosis

    Incidence of any recorded diagnosis of pneumonia in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.

  10. Study 4: The incidence of gastrointestinal infection in adult patients with Alopecia Areata

    Time frame: Within five years of Alopecia Areata diagnosis

    Incidence of any recorded diagnosis of gastrointestinal infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.

  11. Study 4: The incidence of stool confirmed gastrointestinal infection in adult patients with Alopecia Areata

    Time frame: Within five years of Alopecia Areata diagnosis

    Incidence of any recorded diagnosis of gastrointestinal infection confirmed by stool culture or microscopy results (or other microbiological diagnosis confirmation) in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.

  12. Study 4: The incidence of skin infection in adult patients with Alopecia Areata

    Time frame: Within five years of Alopecia Areata diagnosis

    Incidence of any recorded diagnosis of skin infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.

  13. Study 4: The incidence of urinary tract infection in adult patients with Alopecia Areata

    Time frame: Within five years of Alopecia Areata diagnosis

    Incidence of any recorded diagnosis of urinary tract infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.

  14. Study 4: The incidence of genital infection in adult patients with Alopecia Areata

    Time frame: Within five years of Alopecia Areata diagnosis

    Incidence of any recorded diagnosis of genital infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.

  15. Study 4: The incidence of herpes zoster infection in adult patients with Alopecia Areata

    Time frame: Within five years of Alopecia Areata diagnosis

    Incidence of any recorded diagnosis of herpes zoster infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.

  16. Study 4: The incidence of herpes simplex infection in adult patients with Alopecia Areata

    Time frame: Within five years of Alopecia Areata diagnosis

    Incidence of any recorded diagnosis of herpes simplex infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.

Sponsors and collaborators

Lead sponsor

Momentum Data

Industry

Collaborators

  • Pfizer
  • University of Oxford
  • University of Surrey

Registry information

Official study title

The Epidemiology, Management, and the Associated Burden of Mental Health, Atopic and Autoimmune Conditions, and Common Infections in Alopecia Areata

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2020
Registry last updated
Dec 15, 2022

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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