NCT02377557

Observational Study to Assess Safety and Utility Pattern of Topical Steroids

Topical Steroid Registry: Observational Study to Assess Safety and Use Pattern in Korea

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,175 (actual)
• Sponsor: Hanyang University · Academic / Other
• Sex: All
• Age: 19 Years – 69 Years
• Healthy volunteers: Not accepted

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

Conditions

• Skin Diseases

Interventions

Type	Name	Description
DRUG	Topical Steroids

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-01-01
• Completion: 2016-06-01
• First posted: 2015-03-03
• Last updated: 2016-08-17

Locations

1 site across 1 country: South Korea