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Observational Study to Assess Safety and Utility Pattern of Topical Steroids

H

Hanyang University

Status

Completed

Conditions

Skin Diseases

Treatments

Drug: Topical Steroids

Study type

Observational

Funder types

Other

Identifiers

NCT02377557
MFDS2014-20384

Details and patient eligibility

About

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

Full 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

Enrollment

1,175 patients

Sex

All

Ages

19 to 69 years old

Volunteers

No 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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