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NCT05727306 Clinical Trial

Healthcare Disparities in Alopecia Areata

Alopecia Areata Clinical Trial

Official title:
Healthcare Disparities in Alopecia Areata: UK Population-based Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05727306
Other study ID # p068
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date December 1, 2023

Study information
Verified date February 2023
Source Momentum Data
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Alopecia areata (AA) is a common immune-mediated non-scarring alopecia often associated with substantial morbidity. There are however, limited population-based data on potential disparities in the burden of AA, including across people of different ethnicities and deprivation. We aimed to provide the first large-scale, population-based estimate of lifetime risk of AA overall and by important sociodemographic subgroups. As AA is associated with an increased burden of mental health conditions and work-related outcomes (unemployment, time off work), a detailed understanding of the burden of disease in different sociodemographic groups is vital to plan resource provision.

Description:

The overall purpose of the study is to provide an estimate of the cumulative lifetime incidence of AA in the population overall and by important sociodemographic groups. Moreover, to do a subgroup analysis in the AA population to identify health-related disparities across people in different socioeconomic strata, geographical distribution, sex and ethnic groups. The disparities that will be considered are AA associated: Mental health conditions; healthcare utilisation; and work impact (time off work and unemployment). The cumulative lifetime risk of AA was estimated at age 80 years (approximate life expectancy in the UK) using survival models, with age as the timescale and accounting for the competing risk of death. The assessment of any associations with baseline characteristics and the outcomes of interest will be assessed using Cox proportional hazards models (time to event outcomes) and Poisson regression (repeated event outcomes) models.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 30902
Est. completion date December 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers
Gender All
Age group 12 Years to 95 Years
Eligibility Inclusion Criteria: - Patients aged greater than 12 over the study period. - Registered with the contributing primary care practice for any duration during the study period Exclusion Criteria: - People diagnosed with AA before the study period.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
Observational analysis of usual care only.

Locations
Country Name City State
United Kingdom Momentum Data Limited London

Sponsors (3)
Lead Sponsor Collaborator
Momentum Data Pfizer, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Total disease burden Disease burden of Alopecia Areata (AA) measured using cumulative lifetime incidence against age. Measured over 10 years - 2009 - 2018 inclusive.
Secondary Incidence of mental health conditions within patients with AA Describe any disparities in AA related mental health conditions measured by time to first mental health diagnosis 2 years
Secondary Primary care attendance Describe any disparities in AA healthcare utilisation measured by the number of primary care visits. 2 years
Secondary Dermatology referrals Describe any disparities in AA healthcare utilisation measured by the number of dermatology referrals, 2 years
Secondary Psychological therapy Describe any disparities in AA healthcare utilisation measured by the number of referrals for psychological therapy. 2 years
Secondary Psychiatric reviews Describe any disparities in AA healthcare utilisation measured by the number of referrals to psychiatric review. 2 years
Secondary Unemployment Describe any disparities in work-related impact measured by time to first recorded unemployment event. 2 years
Secondary Time off work Describe any disparities in work-related impact measured by time to first recorded time off work sickness event. 2 years
See also
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Active, not recruiting NCT03570749 - A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata Phase 2/Phase 3
Completed NCT02812342 - Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants Phase 2
Completed NCT02350023 - Comparison of Topical Latanoprost vs Topical Corticosteroid in Treatment of Localized Alopecia Areata Phase 4
Completed NCT02018042 - An Open-Label Single-Arm Clinical Trial to Evaluate The Efficacy of Abatacept in Moderate to Severe Patch Type Alopecia Areata Phase 2
Terminated NCT01898806 - Intralesional Steroids in the Treatment of Alopecia Areata Phase 4
Recruiting NCT04011748 - Clinical Application of Stem Cell Educator Therapy in Alopecia Areata Phase 2
Active, not recruiting NCT04517864 - PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA Phase 2
Not yet recruiting NCT05803070 - Topical Cetirizine in Treatment of Localized Alopecia Areata
Not yet recruiting NCT05496426 - A Study of KL130008 in Adults With Severe Alopecia Areata Phase 2
Completed NCT04147845 - Transepidermal Delivery of Triamcinolone Acetonide or Platelet Rich Plasma Using Either Fractional Carbon Dioxide Laser or Microneedling in Treatment of Alopecia Areata N/A
Terminated NCT03325296 - Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata. Phase 2
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Enrolling by invitation NCT05745389 - CorEvitas Alopecia Areata (AA) Safety and Effectiveness Registry
Recruiting NCT04246372 - Tofacitinib for Immune Skin Conditions in Down Syndrome Phase 2
Not yet recruiting NCT06087796 - Topical Pentoxifylline; Metformin Versus Betamethasone in the Treatment of Alopecia Areata. Phase 1
Withdrawn NCT03532958 - Phase 2 Trial of BNZ-1 in Patients With Moderate to Severe Alopecia Areata Phase 2
Recruiting NCT02604888 - Efficacy Study of a Cosmetic Lotion in the Treatment of Alopecia Areata in Males and Females N/A
Terminated NCT01385839 - Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata N/A
Completed NCT00408798 - Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin N/A