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

Study Purpose

This study series consists of three related studies and aims to explore and describe many important elements of Alopecia areata over three key areas: (i) the current epidemiology of Alopecia areata, (ii) the prevalence and incidence of psychiatric co-morbidities in people with Alopecia areata and (iii) the prevalence and incidence of autoimmune and atopic conditions in people with Alopecia areata.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04239521
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Momentum Data
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Andrew McGovern, MD
Principal Investigator Affiliation Momentum Data
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryIndustryOther
Overall Status Not yet recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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
Additional Details

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.

Arms & Interventions

Arms

: Cases

Patients with a confirmed diagnosis of Alopecia areata within the study period will be included as cases for analysis.

: 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.

Interventions

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

Contact a Trial Team

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International Sites

Momentum Data Ltd, London, United Kingdom

Status

Address

Momentum Data Ltd

London, , WC1X 8QT

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