Observational Study to Assess Safety and Utility Pattern of Topical Steroids

Completed

• Conditions: Skin Diseases

• Registration Number: NCT02377557
• Lead Sponsor: Hanyang University

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

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-25
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-03
• Primary Completion: 2016-01
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-15
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1175

Inclusion Criteria

• All patients or guardian of child purchased topical steroids in Korea
• Informed consent to participate
• Willing to follow and abide by the protocol

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of adverse drug reaction upon use of topical steroid	4 week after time of enrollment

Secondary Outcome Measures

Name	Time	Method
Rate of adverse drug reaction upon use of topical steroid	6 month after time of enrollment
Rate of misuse and overuse of topical steroids	6 month after time of enrollment
Impact of covariates on incidence of adverse drug reaction	6 month after time of enrollment
Rate of adverse drug reaction by potency, route of purchase (prescription/self diagnosed), drug classification (prescription only/over the counter)	1 month after time of enrollment

Trial Locations

Locations (1)

College of Pharmacy, Hanyang University; 🇰🇷 Gyeonggi, Korea, Republic of