Atopic DermatitisNCT02126176
Protopic Adherence and Efficacy in Korean Eczema Patient
An observational study of Atopic Dermatitis, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether the dosage of 0.1% tacrolimus ointment applied on unit area of eczema influence the efficacy of treatment. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Mar 2016
- How long will I take part?
- 2 Weeks
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with atopic dermatitis
Who may be able to join
- at least 19 years of age with a diagnosis of atopic dermatitis
- treated with protopic 0.1% ointment
Who cannot join
- treated with other medication or topical agent
- skin lesion on the scalp or hand and foot
- pregnant women/lactating women
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of dermatology, Pusan National University Hospital
Busan, Busan
About this study
The purpose of this study is to determine whether the dosage of 0.1% tacrolimus ointment applied on unit area of eczema influence the efficacy of treatment.
- Conditions
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical assessments of erythema, scaling, and pruritus
EASI score
Measured: 2 weeks
clinical assessments of erythema, scaling, and pruritus
TIS score
Measured: 2 weeks
clinical assessments of erythema, scaling, and pruritus
IGA/PGA score
Measured: 2 weeks
clinical assessments of erythema, scaling, and pruritus
DLQI
Measured: 2 weeks
clinical assessments of erythema, scaling, and pruritus
itching VAS scale
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126176
- Sponsor's protocol ID
- PUNHDM-adherence
- Status last verified
- Mar 2016
- First submitted
- 24 Apr 2014
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protopic Adherence and Efficacy in Korean Eczema Patient
- ClinicalTrials.gov ID
- NCT02126176
- Acronym / sponsor ID
- PUNHDM-adherence
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 29 Apr 2014 (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.
The purpose of this study is to determine whether the dosage of 0.1% tacrolimus ointment applied on unit area of eczema influence the efficacy of treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with atopic dermatitis
Key inclusion criteria (2 listed)
- at least 19 years of age with a diagnosis of atopic dermatitis
- treated with protopic 0.1% ointment
Key exclusion criteria (3 listed)
- treated with other medication or topical agent
- skin lesion on the scalp or hand and foot
- pregnant women/lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
clinical assessments of erythema, scaling, and pruritus
Time frame: 2 weeks
EASI score
clinical assessments of erythema, scaling, and pruritus
Time frame: 2 weeks
TIS score
clinical assessments of erythema, scaling, and pruritus
Time frame: 2 weeks
IGA/PGA score
clinical assessments of erythema, scaling, and pruritus
Time frame: 2 weeks
DLQI
clinical assessments of erythema, scaling, and pruritus
Time frame: 2 weeks
itching VAS scale
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 30 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Atopic Dermatitis, run by Pusan National University Hospital 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 2 inclusion and 3 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 30 Mar 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?
clinical assessments of erythema, scaling, and pruritus (time frame: 2 weeks). The study lists 5 primary outcomes in all. 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 30 Mar 2016.