Protopic Adherence and Efficacy in Korean Eczema Patient

Atopic Dermatitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126176
• Other study ID #: PUNHDM-adherence
• Status: Completed
• Phase: N/A
• First received: April 24, 2014
• Last updated: March 28, 2016
• Start date: May 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Pusan National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
Korea, Republic of	Department of dermatology, Pusan National University Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical assessments of erythema, scaling, and pruritus	EASI score	2 weeks	No
Primary	clinical assessments of erythema, scaling, and pruritus	TIS score	2 weeks	No
Primary	clinical assessments of erythema, scaling, and pruritus	IGA/PGA score	2 weeks	No
Primary	clinical assessments of erythema, scaling, and pruritus	DLQI	2 weeks	No
Primary	clinical assessments of erythema, scaling, and pruritus	itching VAS scale	2 weeks	No