- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02126176
Protopic Adherence and Efficacy in Korean Eczema Patient
March 28, 2016 updated by: Pusan National University Hospital
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Busan, Korea, Republic of
- Department of dermatology, Pusan National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patient with atopic dermatitis
Description
Inclusion Criteria:
- at least 19 years of age with a diagnosis of atopic dermatitis
- treated with protopic 0.1% ointment
Exclusion Criteria:
- treated with other medication or topical agent
- skin lesion on the scalp or hand and foot
- pregnant women/lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
clinical assessments of erythema, scaling, and pruritus
Time Frame: 2 weeks
|
EASI score
|
2 weeks
|
|
clinical assessments of erythema, scaling, and pruritus
Time Frame: 2 weeks
|
TIS score
|
2 weeks
|
|
clinical assessments of erythema, scaling, and pruritus
Time Frame: 2 weeks
|
IGA/PGA score
|
2 weeks
|
|
clinical assessments of erythema, scaling, and pruritus
Time Frame: 2 weeks
|
DLQI
|
2 weeks
|
|
clinical assessments of erythema, scaling, and pruritus
Time Frame: 2 weeks
|
itching VAS scale
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (ACTUAL)
March 1, 2016
Study Completion (ACTUAL)
March 1, 2016
Study Registration Dates
First Submitted
April 24, 2014
First Submitted That Met QC Criteria
April 27, 2014
First Posted (ESTIMATE)
April 29, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
March 30, 2016
Last Update Submitted That Met QC Criteria
March 28, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PUNHDM-adherence
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.