NCT06471114

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

June 24, 2024

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

April 29, 2024

Last Update Submit

June 17, 2024

Conditions

Keywords

severe

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Long-term efficacy of systemic treatments

    From January 2010 to December 2020

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Alopecia AreataLymphoma, Follicular

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

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

Study Record Dates

First Submitted

April 29, 2024

First Posted

June 24, 2024

Study Start

November 1, 2023

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

June 24, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning three years and ending fifteen years following the final study report completion
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

Locations