Observational Study to Assess Safety and Utility Pattern... | NCT02377557

Studies
Observational Study to Assess Safety and Utility Pattern of Topical Steroids

NCT02377557

Sponsor

Hanyang University

Status

Completed

Last Update Posted

Aug 17, 2016Estimated

Enrollment

1,175Actual

Phase

Not provided

Conditions

Skin Diseases

Interventions

Topical Steroids

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Jan 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Feb 25, 2015

First Submission Date that Met QC Criteria

Mar 2, 2015

First Posted Date

Mar 3, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2016

Last Update Posted Date

Aug 17, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ju-Yeun Lee, Ph.D, Hanyang UniversityPrincipal Investigator

Lead Sponsor

Hanyang UniversityOTHER

Collaborators

Name	Class
Korean Ministry of Food and Drug Safety	UNKNOWN
College of Pharmacy, Seoul National University	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,175Actual

Name	Type	Description	Arm Group Labels	Other Names
Topical Steroids	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

All patients or guardian of child purchased topical steroids in Korea

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ju-Yeun Lee, Ph.D.	College of Pharmacy, Hanyang University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
College of Pharmacy, Hanyang University		Gyeonggi-do		426-791	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012871	Skin Diseases

Ancestor Terms

ID	Term
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013256	Steroids

Ancestor Terms

ID	Term
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided