Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06283316
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-12
Brief Title:
Systemic Treatments for Alopecia Areata Registry
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Systemic Treatments for Alopecia Areata Registry
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STA2R
Brief Summary:
A multicenter prospective registry STA2R is conducted to assess systemic treatments for alopecia areata focusing on effectiveness safety and long-term outcomes
Detailed Description:
Rationale
Alopecia areata AA is a dermatological disorder characterized by non-scarring hair loss significantly affecting the quality of life of patients While some patients experience spontaneous hair regrowth or respond well to localized treatments patients with moderate-to-severe AA represent a subgroup that requires more extensive systemic therapies for effective management Currently the clinical management of moderate-to-severe AA is primarily based on expert opinions There is a lack of research on systemic treatments for moderate-to-severe AA comprising only a small number of randomized controlled trials and observational studies Furthermore there is a clear absence of long-term prospective and comparative data on these therapies Most conventional systemic treatments for AA are prescribed off-label underlining the importance of gaining a more comprehensive understanding of their effectiveness and safety
Therefore a long-term prospective registry is conducted This registry will evaluate the real-world utilization of systemic treatments in AA patients aiming to provide valuable insights into the effectiveness safety and long-term outcomes of these therapies By collecting and analyzing such data this registry endeavors to contribute to evidence-based clinical management ultimately improving care for AA patients
Objective
The aim is to establish a comprehensive cohort of AA patients receiving systemic treatments with the primary objective of assessing the short- and long-term effectiveness and safety of various systemic treatments for AA
Study type
This is a long-term multicenter prospective observational non-interventional registry
Study population
All adult AA patients starting systemic treatment who are willing to provide voluntary informed consent prior to inclusion in the registry and comply with the requirements of the registry
Alopecia areata AA is a dermatological disorder characterized by non-scarring hair loss significantly affecting the quality of life of patients While some patients experience spontaneous hair regrowth or respond well to localized treatments patients with moderate-to-severe AA represent a subgroup that requires more extensive systemic therapies for effective management Currently the clinical management of moderate-to-severe AA is primarily based on expert opinions There is a lack of research on systemic treatments for moderate-to-severe AA comprising only a small number of randomized controlled trials and observational studies Furthermore there is a clear absence of long-term prospective and comparative data on these therapies Most conventional systemic treatments for AA are prescribed off-label underlining the importance of gaining a more comprehensive understanding of their effectiveness and safety
Therefore a long-term prospective registry is conducted This registry will evaluate the real-world utilization of systemic treatments in AA patients aiming to provide valuable insights into the effectiveness safety and long-term outcomes of these therapies By collecting and analyzing such data this registry endeavors to contribute to evidence-based clinical management ultimately improving care for AA patients
Objective
The aim is to establish a comprehensive cohort of AA patients receiving systemic treatments with the primary objective of assessing the short- and long-term effectiveness and safety of various systemic treatments for AA
Study type
This is a long-term multicenter prospective observational non-interventional registry
Study population
All adult AA patients starting systemic treatment who are willing to provide voluntary informed consent prior to inclusion in the registry and comply with the requirements of the registry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None