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Completed

NCT Number: NCT02377557

Observational Study to Assess Safety and Utility Pattern of Topical Steroids

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

Completed

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Key information

Conditions

Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

College of Pharmacy, Hanyang University

Gyeonggi-do, 426-791, South Korea

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topical Steroids

Drug

Primary outcomes

  1. Rate of adverse drug reaction upon use of topical steroid

    Time frame: 4 week after time of enrollment

Secondary outcomes

  1. Rate of adverse drug reaction upon use of topical steroid

    Time frame: 2 month after time of enrollment

  2. Rate of adverse drug reaction upon use of topical steroid

    Time frame: 6 month after time of enrollment

  3. Rate of adverse drug reaction by potency, route of purchase (prescription/self diagnosed), drug classification (prescription only/over the counter)

    Time frame: 1 month after time of enrollment

  4. Rate of misuse and overuse of topical steroids

    Time frame: 6 month after time of enrollment

  5. Impact of covariates on incidence of adverse drug reaction

    Time frame: 6 month after time of enrollment

Sponsors and collaborators

Lead sponsor

Hanyang University

Other

Collaborators

  • College of Pharmacy, Seoul National University
  • Korean Ministry of Food and Drug Safety

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 3, 2015
Registry last updated
Aug 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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