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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02377557

Enrollment

1175

Registered

2015-03-03

Start date

2015-02-28

Completion date

2016-06-30

Last updated

2016-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Diseases

Keywords

Dermatologic Agent

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

Interventions

DRUGTopical Steroids

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to 69 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 upon use of topical steroid	2 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026