The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata
NCT ID: NCT04239521
Last Updated: 2022-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
51955 participants
OBSERVATIONAL
2020-10-01
2022-11-28
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cases
Patients with a confirmed diagnosis of Alopecia areata within the study period will be included as cases for analysis.
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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 AA diagnosis within 6 months of registration.
* People with less than 1 year of follow up available
ALL
No
Sponsors
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Pfizer
INDUSTRY
University of Surrey
OTHER
University of Oxford
OTHER
Momentum Data
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew McGovern, MD
Role: STUDY_DIRECTOR
Momentum Data
Locations
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Momentum Data Ltd
London, , United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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P005
Identifier Type: -
Identifier Source: org_study_id