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

Wake Forest University (WFU)

Status and phase: Completed; Phase 4

Conditions: Atopic Dermatitis

Treatments: Drug: tacrolimus ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT00654355

IRB00002300

contract #32417 (Other Identifier)

Details and patient eligibility

About

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

Full description

To evaluate adherence to topical therapy using adherence data collected by the MEMS cap (Medication Electronic Monitoring System) in pediatric patients with atopic dermatitis (AD) and the impact of a return visit.

Enrollment: 30 patients

Sex: All

Ages: 2 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female subjects age 2-15.
2. 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.
3. The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
4. The ability to understand and sign a written informed consent/assent form, which must be obtained prior to treatment.

Exclusion criteria

1. Known allergy to tacrolimus or to any component of the formulations.
2. The use of systemic therapy for atopic dermatitis within the past 4 weeks.
3. Use of prescription topical therapy for atopic dermatitis (e.g., corticosteroids or retinoids) within the past 2 weeks.
4. Use of any investigational therapy within the past 4 weeks.
5. 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.
6. Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Active Drug

Experimental group

Description:

tacrolimus ointment

Treatment:

Drug: tacrolimus ointment