NCT02377557

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,175

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

11 months

First QC Date

February 25, 2015

Last Update Submit

August 15, 2016

Conditions

Skin Diseases

Keywords

Dermatologic Agent

Outcome Measures

Primary Outcomes (1)

  • Rate of adverse drug reaction upon use of topical steroid

    4 week after time of enrollment

Secondary Outcomes (5)

  • 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

Interventions

Topical SteroidsDRUG

Eligibility Criteria

Age19 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients or guardian of child purchased topical steroids in Korea

You may qualify if:

  • All patients or guardian of child purchased topical steroids in Korea
  • Informed consent to participate
  • Willing to follow and abide by the protocol

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Pharmacy, Hanyang University

Gyeonggi-do, 426-791, South Korea

Location

MeSH Terms

Conditions

Skin Diseases

Interventions

Steroids

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Ju-Yeun Lee, Ph.D.

    College of Pharmacy, Hanyang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D

Study Record Dates

First Submitted

February 25, 2015

First Posted

March 3, 2015

Study Start

February 1, 2015

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

August 17, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)