Observational Study to Assess Safety and Utility Pattern of Topical Steroids

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

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

Study Overview

• Status: Completed
• Conditions: Skin Diseases
• Intervention / Treatment: Drug: Topical Steroids

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 Type: Observational
• Enrollment (Actual): 1175

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi, Korea, Republic of, 426-791
    • College of Pharmacy, Hanyang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients or guardian of child purchased topical steroids in Korea

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of adverse drug reaction upon use of topical steroid	4 week after time of enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of adverse drug reaction upon use of topical steroid	2 month after time of enrollment
Rate of adverse drug reaction upon use of topical steroid	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
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

Collaborators and Investigators

• Sponsor: Hanyang University
• Collaborators: Korean Ministry of Food and Drug Safety; College of Pharmacy, Seoul National University
• Investigators: Principal Investigator: Ju-Yeun Lee, Ph.D., College of Pharmacy, Hanyang University

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: February 25, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Estimate): August 17, 2016
• Last Update Submitted That Met QC Criteria: August 15, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Dermatologic Agent
• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: MFDS2014-20384

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No