Measuring Adherence to Topical Therapy in Children With Atopic Dermatitis and the Impact of a Return Visit

Completed · Phase 4

Conditions studied: Atopic Dermatitis

In brief

The purpose of this research study is to better understand how the study drug works when people use it to treat atopic dermatitis.

Key facts

Study ID

NCT00654355

Run by

Wake Forest University

People needed

30

Starts

2008-04-01

Expected to finish

2009-09-01

Last updated by the study team

2018-08-01

Who can join

Age: 2 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects age 2-15.
• Stable or worsening atopic dermatitis affecting 5% or greater body surface area. Face and genital areas can be included in the body surface area determination and treatment area.
• The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
• The ability to understand and sign a written informed consent/assent form, which must be obtained prior to treatment.

You may not qualify if…

• Known allergy to tacrolimus or to any component of the formulations.
• The use of systemic therapy for atopic dermatitis within the past 4 weeks.
• Use of prescription topical therapy for atopic dermatitis (e.g., corticosteroids or retinoids) within the past 2 weeks.
• Use of any investigational therapy within the past 4 weeks.
• Pregnant females, females who are breast feeding, or females of childbearing potential who are not practicing an acceptable method of birth control (abstinence, birth control pill/patch, barrier with spermicidal jelly, IUD, etc.), as determined by the investigator. Acceptable contraception must be used during the entire study. A pregnancy test will be performed on females of childbearing potential at baseline and at week 4.
• Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.

Where it is running

• Dept of Dermatology, WFUHS — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.