Skin DiseasesNCT02377557
Observational Study to Assess Safety and Utility Pattern of Topical Steroids
An observational study of Skin Diseases, run by Hanyang University at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Skin Diseases
- What is being tested?
- Topical Steroids
- How many people
- 1,175 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2015to Jun 2016
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients or guardian of child purchased topical steroids in Korea
Who may be able to join
- All patients or guardian of child purchased topical steroids in Korea
- Informed consent to participate
- Willing to follow and abide by the protocol
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
South Korea1 site
College of Pharmacy, Hanyang University
Gyeonggi-do, 426-791
About this study
Official title: Topical Steroid Registry: Observational Study to Assess Safety and Use Pattern in Korea
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
Read the 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
- Conditions
- Skin Diseases
- Being tested
- Topical Steroids
- Keywords
- Dermatologic Agent
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical SteroidsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adverse drug reaction upon use of topical steroid
Measured: 4 week after time of enrollment
Secondary outcomes (5)
Rate of adverse drug reaction upon use of topical steroid
Measured: 2 month after time of enrollment
Rate of adverse drug reaction upon use of topical steroid
Measured: 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)
Measured: 1 month after time of enrollment
Rate of misuse and overuse of topical steroids
Measured: 6 month after time of enrollment
Impact of covariates on incidence of adverse drug reaction
Measured: 6 month after time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,175 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Ministry of Food and Drug Safety, College of Pharmacy, Seoul National University
- Responsible party
- Principal investigator, Ju-Yeun Lee, Hanyang University
- Investigators
- Ju-Yeun Lee, Ph.D., Principal investigator, College of Pharmacy, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377557
- Sponsor's protocol ID
- MFDS2014-20384
- Status last verified
- Aug 2016
- First submitted
- 25 Feb 2015
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Steroid Registry: Observational Study to Assess Safety and Use Pattern in Korea
- ClinicalTrials.gov ID
- NCT02377557
- Acronym / sponsor ID
- MFDS2014-20384
- Conditions
- Skin Diseases
- Keywords
- Dermatologic Agent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,175 participants (actual)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Collaborators
- Korean Ministry of Food and Drug Safety, College of Pharmacy, Seoul National University
- Study start
- Feb 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients or guardian of child purchased topical steroids in Korea
Key inclusion criteria (3 listed)
- All patients or guardian of child purchased topical steroids in Korea
- Informed consent to participate
- Willing to follow and abide by the protocol
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical Steroids | Drug | – |
Primary outcome
Rate of adverse drug reaction upon use of topical steroid
Time frame: 4 week after time of enrollment
5 secondary outcomes
Rate of adverse drug reaction upon use of topical steroid
Time frame: 2 month after time of enrollment
Rate of adverse drug reaction upon use of topical steroid
Time frame: 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)
Time frame: 1 month after time of enrollment
Rate of misuse and overuse of topical steroids
Time frame: 6 month after time of enrollment
Impact of covariates on incidence of adverse drug reaction
Time frame: 6 month after time of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ju-Yeun Lee, Ph.D. principal investigator
College of Pharmacy, Hanyang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Diseases, run by Hanyang University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of adverse drug reaction upon use of topical steroid (time frame: 4 week after time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.