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

NCT ID: NCT00654355

Last Updated: 2018-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-09-30

Brief Summary

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

Detailed 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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Drug

tacrolimus ointment

Group Type: EXPERIMENTAL

tacrolimus ointment

Intervention Type: DRUG

tacrolimus ointment to be applied twice daily to affected areas during duration of study

Interventions

tacrolimus ointment

tacrolimus ointment to be applied twice daily to affected areas during duration of study

Intervention Type: DRUG

Other Intervention Names

Protopic Ointment

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve Feldman, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

WFUHS

Locations

Dept of Dermatology, WFUHS

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

contract #32417

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00002300

Identifier Type: -

Identifier Source: org_study_id