Clinical trial NCT05588310: Quantification of the Socio-economic Multifacet Burden of Alopecia Areata and Identification of the Associated Factors
Official title: Quantification of the Socio-economic Multifacet Burden of Alopecia Areata and Identification of the Associated Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alopecia Areata
Keywords: Socio-economic burden
alopecia areata
out-of-pocket expenditures
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2022-10-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients whom suffer from Alopecia Areata

Brief summary: Alopecia areata (AA) is a complex autoimmune disorder with an estimated lifetime risk of 1.7% where both genetic pre-disposition and environmental factors contribute. It typically presents with sharply demarcated round patches of non-scarring hair loss that may present at any age. Many patients with AA are dissatisfied with current medical treatments and use alternative therapies and cosmetics. This study will generate new data on the current situation of psychosocial and financial burden of AA. It will help to identify unmet needs and to understand the disease issues. It will also be the basis for the planification of future supporting measures.

Detailed description: Alopecia areata (AA) is a complex autoimmune disorder with an estimated lifetime risk of 1.7% where both genetic pre-disposition and environmental factors contribute. It typically presents with sharply demarcated round patches of non-scarring hair loss that may present at any age. Current medical therapies (topical or systemic) for AA are not reliably effective, particularly for severe disease and there is no robust evidence from high-quality randomized controlled trials. Patients with AA experience significant mental health and health related quality of life (HRQoL) impairment. Furthermore, at the country level, skin conditions such as AA ranged from 2nd to 11th leading cause of years lived with disability. It was shown that AA appears to affect all countries across the world similarly, and the health burden has remained stable despite substantial advances in healthcare and health-related resources. More recently, Mesinkovska et al demonstrated that the impact of AA extends beyond cosmetic concerns and carries a considerable psychosocial burden.

Many patients with AA are dissatisfied with current medical treatments and use alternative therapies and cosmetics. Cosmetics and not reimbursed treatments can weigh heavily on patients spending.This study will generate new data on the current situation of psychosocial and financial burden of AA. It will help to identify unmet needs and to understand the disease issues. It will also be the basis for the planification of future supporting measures.

Eligibility criteria: Inclusion Criteria:

* Adult patients (\> 18 years).
* Alopecia Areata whose diagnosis has been confirmed by a dermatologist according to the standardized diagnostic criteria.
* \< 2 years duration of current episode of scalp hair loss.
* Severity \> S2 (\> 25% hair loss) as assessed by the Alopecia Tool (SALT).

Exclusion Criteria:

* Patients under juridical protection.
* Patients not covered by social security.
* Patients unable to understand French

Primary outcomes:
measure: Calculate the Out Of Pocket (OOP) expenditures of patients whom suffer from alopecia areata
timeFrame: 12 months
Secondary outcomes:
measure: Calculate direct medical costs and indirect costs limited to work stopping and working reduction time related to Alopecia Areata
timeFrame: 12 months
measure: Evaluate the impact of Alopecia Areata on Health Related Quality of Life (HRQoL) - DLQI
timeFrame: 6 months
measure: Evaluate the impact of Alopecia Areata on Health Related Quality of Life (HRQoL) - AA-QLI
timeFrame: 6 months
measure: Evaluate the patient's perceived stress
timeFrame: 6 months
measure: Evaluate the impact of Alopecia Areata on depression symptoms
timeFrame: 6 months
measure: Evaluate the impact of Alopecia Areata on anxiety symptoms
timeFrame: 6 months
measure: Describing the care pathway for Alopecia Areata patients
timeFrame: 6 months
measure: Describing the impact of Alopecia Areata on work productivity
timeFrame: 6 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse University hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Juliette Mazereeuw-Hautier, Pr
role: PRINCIPAL_INVESTIGATOR
References: