Clinical trial NCT04239521: The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata
Official title: The Epidemiology, Management, and the Associated Burden of Mental Health, Atopic and Autoimmune Conditions, and Common Infections in Alopecia Areata
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alopecia Areata
Depressive Episode
Recurrent Depressive Disorder
Anxiety Disorders
Atopic Dermatitis
Allergic Rhinitis
Asthma
Crohn Disease
Ulcerative Colitis
Pernicious Anemia
Type 1 Diabetes
Hashimoto Thyroiditis
Graves Disease
Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Systemic Lupus Erythematosus
Polymyalgia Rheumatica
Sjogren's Syndrome
Psoriasis
Vitiligo
Multiple Sclerosis
Celiac Disease
Upper Respiratory Tract Infection
Influenza
Lower Resp Tract Infection
Acute Bronchitis
Pneumonia
Gastrointestinal Infection
Skin Infection
Urinary Tract Infections
Genital Infection
Herpes Zoster
Herpes Simplex
Infection
Infection Viral
Keywords: Alopecia areata
Common mental health conditions
Depression
Anxiety
Autoimmune disease
Atopic conditions
Epidemiology
Incidence
Prevalence
Infection
Lead sponsor: Momentum Data
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
name: University of Surrey
name: University of Oxford
First posted: 2020-01-27
Enrollment: 51955
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: These studies will use routinely collected and collated data from the Royal College of General Practitioners Research and Surveillance Centre database to provide a broadly representative sample of the population of England.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Study 1: The incidence of Alopecia Areata
timeFrame: Overall during 2009-2018 inclusive
measure: Study 1: The incidence of Alopecia Areata stratified by sociodemographic factors
timeFrame: Overall during 2009-2018 inclusive
measure: Study 1:The annual rate of primary care visits for people with Alopecia Areata.
timeFrame: Within one year of diagnosis of Alopecia Areata
measure: Study 1: Secondary care dermatology service utilisation
timeFrame: Within one year of diagnosis of Alopecia Areata
measure: Study 2: The prevalence of common mental health conditions in adult patients diagnosed with Alopecia Areata at the time of diagnosis
timeFrame: At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive
measure: Study 2: Describe the incidence of common mental health conditions in adult patients with Alopecia Areata
timeFrame: Within two years of diagnosis of Alopecia Areata
measure: Study 2: Describe the mental health medication treatment burden of adult patients diagnosed with Alopecia Areata.
timeFrame: Within two years of diagnosis of Alopecia Areata
measure: Study 2: Number of patients diagnosed with Alopecia Areata receiving mental health psychological intervention.
timeFrame: Within two years of diagnosis of Alopecia Areata
measure: Study 3: Describe the prevalence of atopic and autoimmune conditions in adult patients diagnosed with Alopecia Areata at the time of diagnosis
timeFrame: At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive
measure: Study 3: Describe the incidence of atopic and autoimmune conditions in adult patients with Alopecia Areata.
timeFrame: Within five years of Alopecia Areata diagnosis
measure: Study 4: The incidence of a composite of common infections in adult patients with Alopecia Areata
timeFrame: Within five years of Alopecia Areata diagnosis
measure: Study 4: The incidence of a composite of viral infections in adult patients with Alopecia Areata
timeFrame: Within five years of Alopecia Areata diagnosis
Secondary outcomes:
measure: Study 1: Adjusted incidence rate ratios of Alopecia Areata within England by geographic region.
timeFrame: Overall during 2009-2018 inclusive
measure: 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.
timeFrame: At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive
measure: Study 2: Describe the burden of 'sick days' in adult patients diagnosed with Alopecia Areata relating to mental health conditions.
timeFrame: Within one year of diagnosis of Alopecia Areata
measure: Study 2: Describe the prevalence of unemployment in adult patients diagnosed with Alopecia Areata.
timeFrame: Within one year of diagnosis of Alopecia Areata
measure: Study 4: The incidence of upper respiratory tract infection in adult patients with Alopecia Areata
timeFrame: Within five years of Alopecia Areata diagnosis
measure: Study 4: The incidence of lower respiratory tract infection in adult patients with Alopecia Areata
timeFrame: Within five years of Alopecia Areata diagnosis
measure: Study 4: The incidence of influenza infection in adult patients with Alopecia Areata
timeFrame: Within five years of Alopecia Areata diagnosis
measure: Study 4: The incidence of acute bronchitis in adult patients with Alopecia Areata
timeFrame: Within five years of Alopecia Areata diagnosis
measure: Study 4: The incidence of pneumonia in adult patients with Alopecia Areata
timeFrame: Within five years of Alopecia Areata diagnosis
measure: Study 4: The incidence of gastrointestinal infection in adult patients with Alopecia Areata
timeFrame: Within five years of Alopecia Areata diagnosis
measure: Study 4: The incidence of stool confirmed gastrointestinal infection in adult patients with Alopecia Areata
timeFrame: Within five years of Alopecia Areata diagnosis
measure: Study 4: The incidence of skin infection in adult patients with Alopecia Areata
timeFrame: Within five years of Alopecia Areata diagnosis
measure: Study 4: The incidence of urinary tract infection in adult patients with Alopecia Areata
timeFrame: Within five years of Alopecia Areata diagnosis
measure: Study 4: The incidence of genital infection in adult patients with Alopecia Areata
timeFrame: Within five years of Alopecia Areata diagnosis
measure: Study 4: The incidence of herpes zoster infection in adult patients with Alopecia Areata
timeFrame: Within five years of Alopecia Areata diagnosis
measure: Study 4: The incidence of herpes simplex infection in adult patients with Alopecia Areata
timeFrame: Within five years of Alopecia Areata diagnosis
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Momentum Data Ltd
Study officials:
affiliation: Momentum Data
name: Andrew McGovern, MD
role: STUDY_DIRECTOR
References:
citation: Macbeth AE, Holmes S, Harries M, Chiu WS, Tziotzios C, de Lusignan S, Messenger AG, Thompson AR. The associated burden of mental health conditions in alopecia areata: a population-based study in UK primary care. Br J Dermatol. 2022 Jul;187(1):73-81. doi: 10.1111/bjd.21055. Epub 2022 May 11.
citation: Harries M, Macbeth AE, Holmes S, Thompson AR, Chiu WS, Gallardo WR, Messenger AG, Tziotzios C, de Lusignan S. Epidemiology, management and the associated burden of mental health illness, atopic and autoimmune conditions, and common infections in alopecia areata: protocol for an observational study series. BMJ Open. 2021 Nov 16;11(11):e045718. doi: 10.1136/bmjopen-2020-045718.