Alopecia AreataNCT04239521
The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata
An observational study of Alopecia Areata and Depressive Episode, run by Momentum Data at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alopecia Areata, Depressive Episode, Recurrent Depressive Disorder
- What is being tested?
- Exposure of interest (studies 2 & 3).
- How many people
- 51,955 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2020to 28 Nov 2022
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Epidemiology, Management, and the Associated Burden of Mental Health, Atopic and Autoimmune Conditions, and Common Infections 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.
Read the 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.
- Conditions
- Alopecia Areata, Depressive Episode, Recurrent Depressive Disorder, Anxiety Disorders, Atopic Dermatitis, Allergic Rhinitis
- Being tested
- Exposure of interest (studies 2 & 3).
- Keywords
- Alopecia areata, Common mental health conditions, Depression, Anxiety, Autoimmune disease, Atopic conditions, Epidemiology, Incidence, Prevalence, Infection
- Medical subject headings
- Alopecia Areata, Depressive Disorder, Anxiety Disorders, Dermatitis, Atopic, Rhinitis, Allergic, Asthma, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with a confirmed diagnosis of Alopecia areata within the study period will be included as cases for analysis. Receives: Other: Exposure of interest (studies 2 & 3). | |
| Controls | The control cohorts will be defined by matching cases with patients who have never been diagnosed with Alopecia areata either prior to or during the study period, by age and sex, at General Practice practice level. Receives: Other: Exposure of interest (studies 2 & 3). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study 1: The incidence of Alopecia Areata
The incidence of Alopecia areata within the study cohort during the study period
Measured: Overall during 2009-2018 inclusive
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.
Measured: Overall during 2009-2018 inclusive
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.
Measured: Within one year of diagnosis of Alopecia Areata
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
Measured: Within one year of diagnosis of Alopecia Areata
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.
Measured: At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive
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.
Measured: Within two years of diagnosis of Alopecia Areata
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.
Measured: Within two years of diagnosis of Alopecia Areata
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.
Measured: Within two years of diagnosis of Alopecia Areata
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.
Measured: At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive
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.
Measured: Within five years of Alopecia Areata diagnosis
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.
Measured: Within five years of Alopecia Areata diagnosis
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.
Measured: Within five years of Alopecia Areata diagnosis
Secondary outcomes (16)
Study 1: Adjusted incidence rate ratios of Alopecia Areata within England by geographic region.
By region across England.
Measured: Overall during 2009-2018 inclusive
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.
Measured: At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive
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.
Measured: Within one year of diagnosis of Alopecia Areata
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.
Measured: Within one year of diagnosis of Alopecia Areata
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.
Measured: Within five years of Alopecia Areata diagnosis
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.
Measured: Within five years of Alopecia Areata diagnosis
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.
Measured: Within five years of Alopecia Areata diagnosis
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.
Measured: Within five years of Alopecia Areata diagnosis
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.
Measured: Within five years of Alopecia Areata diagnosis
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.
Measured: Within five years of Alopecia Areata diagnosis
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.
Measured: Within five years of Alopecia Areata diagnosis
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.
Measured: Within five years of Alopecia Areata diagnosis
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.
Measured: Within five years of Alopecia Areata diagnosis
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.
Measured: Within five years of Alopecia Areata diagnosis
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.
Measured: Within five years of Alopecia Areata diagnosis
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.
Measured: Within five years of Alopecia Areata diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Oct 2020
- Primary completion31 Mar 2022
- Study completion28 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 51,955 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momentum Data
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer, University of Surrey, University of Oxford
- Responsible party
- Sponsor
- Investigators
- Andrew McGovern, MD, Study director, Momentum Data
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239521
- Sponsor's protocol ID
- P005
- Status last verified
- Dec 2022
- First submitted
- 9 Jan 2020
- Last updated
- 15 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data is confidential but can be made available in an anonymised form to bone fide researchers subject to the required data protection training and other requirements. All data will remain behind a firewall and will only be available for access through a secured computer network.
Publications
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.
PubMed 35157313Harries 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.
PubMed 34785540