Evaluation of the Efficacy of Systemic Treatments for Alopecia (ESTAA) (ESTAA)

Evaluation of the Efficacy of Systemic Treatments for Alopecia

The aim of our study was to retrospectively assess the efficacy and safety of systemic treatments in patients with alopecia areata, by recruiting cases from the HUGO network (Hôpitaux Universitaires du Grand Ouest), a network of 5 hospitals : Brest, Nantes, Rennes, Angers and Tours.

Study Overview

• Status: Active, not recruiting
• Conditions: Alopecia Areata

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHU Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients selected from 5 university hospitals in the HUGO network (Brest, Rennes, Tours, Angers, Nantes).

Description

Inclusion Criteria:

• Patient with severe alopecia
• Has received at least one systemic treatment for at least 3 months (among methotrexate, intravenous or oral corticosteroid therapy, Ciclosporin, UVA/UVB phototherapy)
• Patient affiliated to a social security scheme
• Age greater than or equal to 18 years

Exclusion Criteria:

• Patients under legal protection (guardianship, curatorship, etc.)
• Refusal to participate
• Other cause of alopecia
• Follow-up less than 3 months
• Age under 18 years

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term efficacy and security of systemic treatments	Response rates including complete response or partial response or no response for each modality of treatment. and Side effects rate	From January 2010 to December 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term efficacy of systemic treatments	Among responders (CR and PR), the maintained response rate and relapse rate	From January 2010 to December 2020

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: severe
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: 29BRC23.0239 - ESTAA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No