Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-29 @ 8:57 PM
Study NCT ID:
NCT02377557
Status:
COMPLETED
Last Update Posted:
2016-08-17
First Post:
2015-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study to Assess Safety and Utility Pattern of Topical Steroids
Sponsor:
Hanyang University
Organization:
Study Overview
Official Title:
Topical Steroid Registry: Observational Study to Assess Safety and Use Pattern in Korea
Status:
COMPLETED
Status Verified Date:
2016-08
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:
None
Brief Summary:
To assess incidence of adverse drug reactions and use pattern of topical steroids among patients who are prescribed or purchase over the counter (OTC) topical steroids for skin conditions in Korea
Detailed Description:
* Active collection of safety data, systemic and local adverse events.
* In addition to spontaneous adverse event reports, patients will be asked on occurrence of adverse events upon use of topical steroids at 1 month, 2 month, and 6 month after study enrollment by e-mail or phone call
* Causality of adverse events will be assessed by independent two professionals
* Document the utility pattern of topical steroid, misuse (inappropriate indication) or overuse (in terms of application frequency or treatment duration)
* Collection of information related with adverse event management
* In addition to spontaneous adverse event reports, patients will be asked on occurrence of adverse events upon use of topical steroids at 1 month, 2 month, and 6 month after study enrollment by e-mail or phone call
* Causality of adverse events will be assessed by independent two professionals
* Document the utility pattern of topical steroid, misuse (inappropriate indication) or overuse (in terms of application frequency or treatment duration)
* Collection of information related with adverse event management
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: