NCT04239521

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51,955

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2022

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

1.5 years

First QC Date

January 9, 2020

Last Update Submit

December 13, 2022

Conditions

Alopecia AreataDepressive EpisodeRecurrent Depressive DisorderAnxiety DisordersAtopic DermatitisAllergic RhinitisAsthmaCrohn DiseaseUlcerative ColitisPernicious AnemiaType 1 DiabetesHashimoto ThyroiditisGraves DiseaseRheumatoid ArthritisPsoriatic ArthritisAnkylosing SpondylitisSystemic Lupus ErythematosusPolymyalgia RheumaticaSjogren's SyndromePsoriasisVitiligoMultiple SclerosisCeliac DiseaseUpper Respiratory Tract InfectionInfluenzaLower Resp Tract InfectionAcute BronchitisPneumoniaGastrointestinal InfectionSkin InfectionUrinary Tract InfectionsGenital InfectionHerpes ZosterHerpes SimplexInfectionInfection Viral

Keywords

Alopecia areataCommon mental health conditionsDepressionAnxietyAutoimmune diseaseAtopic conditionsEpidemiologyIncidencePrevalenceInfection

Outcome Measures

Primary Outcomes (12)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (16)

  • Study 1: Adjusted incidence rate ratios of Alopecia Areata within England by geographic region.

    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.

    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.

    Within one year of diagnosis of Alopecia Areata

  • Study 2: Describe the prevalence of unemployment in adult patients diagnosed with Alopecia Areata.

    Within one year of diagnosis of Alopecia Areata

  • Study 4: The incidence of upper respiratory tract infection in adult patients with Alopecia Areata

    Within five years of Alopecia Areata diagnosis

  • +11 more secondary outcomes

Study Arms (2)

Cases

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

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.

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

Interventions

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

CasesControls

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Momentum Data Ltd

London, WC1X 8QT, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 35157313DERIVED

  • 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.

    PMID: 34785540DERIVED

MeSH Terms

Conditions

Alopecia AreataDepressive DisorderAnxiety DisordersDermatitis, AtopicRhinitis, AllergicAsthmaCrohn DiseaseColitis, UlcerativeAnemia, PerniciousDiabetes Mellitus, Type 1Hashimoto DiseaseGraves DiseaseArthritis, RheumatoidArthritis, PsoriaticSpondylitis, AnkylosingLupus Erythematosus, SystemicPolymyalgia RheumaticaSjogren's SyndromePsoriasisVitiligoMultiple SclerosisCeliac DiseaseRespiratory Tract InfectionsInfluenza, HumanBronchitisPneumoniaCellulitisUrinary Tract InfectionsHerpes ZosterHerpes SimplexInfectionsVirus DiseasesDepressionAutoimmune Diseases

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesMood DisordersMental DisordersSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesBronchial DiseasesLung Diseases, ObstructiveLung DiseasesInflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic DiseasesAnemia, MegaloblasticAnemia, MacrocyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesVitamin B 12 DeficiencyVitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesThyroiditis, AutoimmuneThyroiditisThyroid DiseasesExophthalmosOrbital DiseasesEye DiseasesGoiterHyperthyroidismArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesSkin Diseases, PapulosquamousAxial SpondyloarthritisAnkylosisMuscular DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesHypopigmentationPigmentation DisordersDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesMalabsorption SyndromesOrthomyxoviridae InfectionsRNA Virus InfectionsSkin Diseases, InfectiousSuppurationInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesVaricella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsSkin Diseases, ViralBehavioral SymptomsBehavior

Study Officials

  • Andrew McGovern, MD

    Momentum Data

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 27, 2020

Study Start

October 1, 2020

Primary Completion

March 31, 2022

Study Completion

November 28, 2022

Last Updated

December 15, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
There is no pre-specified time-frame for data availability; this will be considered on an individual basis for each request.
Access Criteria
As above

Locations

GB(1)