Observational Study to Assess Safety and Utility Pattern of Topical Steroids

Skin Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377557
• Other study ID #: MFDS2014-20384
• Status: Completed
• Phase: N/A
• First received: February 25, 2015
• Last updated: August 15, 2016
• Start date: February 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Hanyang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1175
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 69 Years

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Skin Diseases

Intervention

Drug:
• Topical Steroids

Locations

Country	Name	City	State
Korea, Republic of	College of Pharmacy, Hanyang University	Gyeonggi

Sponsors (3)

Lead Sponsor	Collaborator
Hanyang University	College of Pharmacy, Seoul National University, Korean Ministry of Food and Drug Safety

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of adverse drug reaction upon use of topical steroid		4 week after time of enrollment	Yes
Secondary	Rate of adverse drug reaction upon use of topical steroid		2 month after time of enrollment	Yes
Secondary	Rate of adverse drug reaction upon use of topical steroid		6 month after time of enrollment	Yes
Secondary	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	Yes
Secondary	Rate of misuse and overuse of topical steroids		6 month after time of enrollment	No
Secondary	Impact of covariates on incidence of adverse drug reaction		6 month after time of enrollment	Yes