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

NCT05588310 | Unknown

• 2 other identifiers: RC31/22/00542022-A00986-37
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Keywords

Socio-economic burden; alopecia areata; out-of-pocket expenditures

Outcome Measures

Primary Outcomes (1)

• Calculate the Out Of Pocket (OOP) expenditures of patients whom suffer from alopecia areata

  To describe the OOP expenditures related to Alopecia Areata from a patient point of view by using the retrospective questionnaire during 6 months and using the prospective weekly follow-up patient diary during 6 months.

  12 months

Secondary Outcomes (8)

• Calculate direct medical costs and indirect costs limited to work stopping and working reduction time related to Alopecia Areata

  12 months

• Evaluate the impact of Alopecia Areata on Health Related Quality of Life (HRQoL) - DLQI

  6 months

• Evaluate the impact of Alopecia Areata on Health Related Quality of Life (HRQoL) - AA-QLI

  6 months

• Evaluate the patient's perceived stress

  6 months

• Evaluate the impact of Alopecia Areata on depression symptoms

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients whom suffer from Alopecia Areata

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Pfizer: collaborator

Study Sites (1)

Toulouse University hospital

Toulouse, 31300, France

RECRUITING

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Juliette Mazereeuw-Hautier, Pr

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliette Mazereeuw-Hautier, Pr

CONTACT

05 67 77 81 26; mazereeuw-hautier.j@chu-toulouse.fr

Hélène TEXIER

CONTACT

05 67 77 81 80; texier.h@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: October 20, 2022
• Study Start: November 8, 2022
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 15, 2023

Record last verified: 2023-05

Locations

FR (1)