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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04239521
• Other study ID #: P005
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: November 28, 2022

Study information

• Verified date: December 2022
• Source: Momentum Data
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51955
• Est. completion date: November 28, 2022
• Est. primary completion date: March 31, 2022
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Bronchitis
• Allergic Rhinitis
• Alopecia
• Alopecia Areata
• Ankylosing Spondylitis
• Anxiety Disorders
• Arthritis
• Arthritis, Psoriatic
• Asthma
• Atopic Dermatitis
• Bronchitis
• Celiac Disease
• Communicable Diseases
• Crohn Disease
• Depressive Disorder
• Depressive Episode
• Dermatitis
• Disease
• Gastrointestinal Infection
• Genital Infection
• Giant Cell Arteritis
• Graves Disease
• Hashimoto Disease
• Hashimoto Thyroiditis
• Herpes Simplex
• Herpes Zoster
• Infection
• Infection Viral
• Infections
• Influenza
• Lower Resp Tract Infection
• Lupus Erythematosus, Systemic
• Multiple Sclerosis
• Pernicious Anemia
• Pneumonia
• Polymyalgia Rheumatica
• Psoriasis
• Psoriatic Arthritis
• Recurrent Depressive Disorder
• Respiratory Tract Infections
• Rheumatoid Arthritis
• Sjogren's Syndrome
• Skin Infection
• Spondylitis
• Spondylitis, Ankylosing
• Systemic Lupus Erythematosus
• Thyroiditis
• Type 1 Diabetes
• Ulcerative Colitis
• Upper Respiratory Tract Infection
• Urinary Tract Infections
• Virus Diseases
• Vitiligo

Intervention

Other:
• Exposure of interest (studies 2 & 3).
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

Locations

Country	Name	City	State
United Kingdom	Momentum Data Ltd	London

Sponsors (4)

Lead Sponsor	Collaborator
Momentum Data	Pfizer, University of Oxford, University of Surrey

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study 1: The incidence of Alopecia Areata	The incidence of Alopecia areata within the study cohort during the study period	Overall during 2009-2018 inclusive
Primary	Study 1: The incidence of Alopecia Areata stratified by sociodemographic factors	This will comprise of the incidence of Alopecia Areata over the study period, by age group, gender, ethnicity, and Social Economic Status.	Overall during 2009-2018 inclusive
Primary	Study 1:The annual rate of primary care visits for people with Alopecia Areata.	The annual rate of visits to primary care for any reason within one year of diagnosis.	Within one year of diagnosis of Alopecia Areata
Primary	Study 1: Secondary care dermatology service utilisation	The percent of people reviewed in secondary care dermatology services within one year of diagnosis of Alopecia Areata	Within one year of diagnosis of Alopecia Areata
Primary	Study 2: The prevalence of common mental health conditions in adult patients diagnosed with Alopecia Areata at the time of diagnosis	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.	At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive
Primary	Study 2: Describe the incidence of common mental health conditions in adult patients with 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.	Within two years of diagnosis of Alopecia Areata
Primary	Study 2: Describe the mental health medication treatment burden of adult patients diagnosed with 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.	Within two years of diagnosis of Alopecia Areata
Primary	Study 2: Number of patients diagnosed with Alopecia Areata receiving mental health psychological intervention.	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.	Within two years of diagnosis of Alopecia Areata
Primary	Study 3: Describe the prevalence of atopic and autoimmune conditions in adult patients diagnosed with Alopecia Areata at the time of diagnosis	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.	At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive
Primary	Study 3: Describe the incidence of atopic and autoimmune conditions in adult patients with Alopecia Areata.	Incidence of atopic and autoimmune conditions in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis
Primary	Study 4: The incidence of a composite of common infections in adult patients with Alopecia Areata	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.	Within five years of Alopecia Areata diagnosis
Primary	Study 4: The incidence of a composite of viral infections in adult patients with Alopecia Areata	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.	Within five years of Alopecia Areata diagnosis
Secondary	Study 1: Adjusted incidence rate ratios of Alopecia Areata within England by geographic region.	By region across England.	Overall during 2009-2018 inclusive
Secondary	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.	By age group, gender, ethnicity, and Social Economic Status.	At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive
Secondary	Study 2: Describe the burden of 'sick days' in adult patients diagnosed with Alopecia Areata relating to mental health conditions.	Sick days will be indicated by the issuing of Med 3 certification from primary care (Statement of Fitness for Work) certification.	Within one year of diagnosis of Alopecia Areata
Secondary	Study 2: Describe the prevalence of unemployment in adult patients diagnosed with 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.	Within one year of diagnosis of Alopecia Areata
Secondary	Study 4: The incidence of upper respiratory tract infection in adult patients with Alopecia Areata	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.	Within five years of Alopecia Areata diagnosis
Secondary	Study 4: The incidence of lower respiratory tract infection in adult patients with Alopecia Areata	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.	Within five years of Alopecia Areata diagnosis
Secondary	Study 4: The incidence of influenza infection in adult patients with Alopecia Areata	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.	Within five years of Alopecia Areata diagnosis
Secondary	Study 4: The incidence of acute bronchitis in adult patients with Alopecia Areata	Incidence of any recorded diagnosis of acute bronchitis in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis
Secondary	Study 4: The incidence of pneumonia in adult patients with Alopecia Areata	Incidence of any recorded diagnosis of pneumonia in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis
Secondary	Study 4: The incidence of gastrointestinal infection in adult patients with Alopecia Areata	Incidence of any recorded diagnosis of gastrointestinal infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis
Secondary	Study 4: The incidence of stool confirmed gastrointestinal infection in adult patients with Alopecia Areata	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.	Within five years of Alopecia Areata diagnosis
Secondary	Study 4: The incidence of skin infection in adult patients with Alopecia Areata	Incidence of any recorded diagnosis of skin infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis
Secondary	Study 4: The incidence of urinary tract infection in adult patients with Alopecia Areata	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.	Within five years of Alopecia Areata diagnosis
Secondary	Study 4: The incidence of genital infection in adult patients with Alopecia Areata	Incidence of any recorded diagnosis of genital infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.	Within five years of Alopecia Areata diagnosis
Secondary	Study 4: The incidence of herpes zoster infection in adult patients with Alopecia Areata	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.	Within five years of Alopecia Areata diagnosis
Secondary	Study 4: The incidence of herpes simplex infection in adult patients with Alopecia Areata	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.	Within five years of Alopecia Areata diagnosis