Observational Study to Assess Safety and Utility Pattern of Topical Steroids

NCT ID: NCT02377557

Last Updated: 2016-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-06-30

Brief Summary

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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

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* 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

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Skin Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Topical Steroids

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korean Ministry of Food and Drug Safety

UNKNOWN

Sponsor Role collaborator

College of Pharmacy, Seoul National University

UNKNOWN

Sponsor Role collaborator

Hanyang University

OTHER

Sponsor Role lead

Responsible Party

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Ju-Yeun Lee

Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ju-Yeun Lee, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

College of Pharmacy, Hanyang University

Locations

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College of Pharmacy, Hanyang University

Gyeonggi-do, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MFDS2014-20384

Identifier Type: -

Identifier Source: org_study_id

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