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Observational Study to Assess Safety and Utility Pattern of Topical Steroids

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ClinicalTrials.gov Identifier: NCT02377557
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : August 17, 2016
Sponsor:
Collaborators:
Korean Ministry of Food and Drug Safety
College of Pharmacy, Seoul National University
Information provided by (Responsible Party):
Ju-Yeun Lee, Hanyang University

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

Condition or disease Intervention/treatment
Skin Diseases Drug: Topical Steroids

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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1175 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Topical Steroid Registry: Observational Study to Assess Safety and Use Pattern in Korea
Study Start Date : February 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions




Primary Outcome Measures :
  1. Rate of adverse drug reaction upon use of topical steroid [ Time Frame: 4 week after time of enrollment ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients or guardian of child purchased topical steroids in Korea
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377557


Locations
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Korea, Republic of
College of Pharmacy, Hanyang University
Gyeonggi, Korea, Republic of, 426-791
Sponsors and Collaborators
Hanyang University
Korean Ministry of Food and Drug Safety
College of Pharmacy, Seoul National University
Investigators
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Principal Investigator: Ju-Yeun Lee, Ph.D. College of Pharmacy, Hanyang University
Additional Information:

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Responsible Party: Ju-Yeun Lee, Ph.D, Hanyang University
ClinicalTrials.gov Identifier: NCT02377557    
Other Study ID Numbers: MFDS2014-20384
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ju-Yeun Lee, Hanyang University:
Dermatologic Agent
Additional relevant MeSH terms:
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Skin Diseases