Quantification of the Socio-economic Multifacet Burden of Alopecia Areata and Identification of the Associated Factors

NCT ID: NCT05588310

Last Updated: 2023-05-15

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-08

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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Alopecia Areata

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juliette Mazereeuw-Hautier, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Toulouse University hospital

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Juliette Mazereeuw-Hautier, Pr

Role: CONTACT

05 67 77 81 26 ext. +33

Hélène TEXIER

Role: CONTACT

05 67 77 81 80 ext. +33

Facility Contacts

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Juliette MAZEREEUW-HAUTIER, Pr

Role: primary

05 67 77 81 26 ext. +33

Hélène TEXIER

Role: backup

05 67 77 81 80 ext. +33

Other Identifiers

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2022-A00986-37

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/22/0054

Identifier Type: -

Identifier Source: org_study_id

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