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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654355
• Other study ID #: IRB00002300
• Secondary ID: contract #32417
• Status: Completed
• Phase: Phase 4
• Start date: April 2008
• Est. completion date: September 2009

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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

Locations

Country	Name	City	State
United States	Dept of Dermatology, WFUHS	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	adherence to topical therapy in children via MEMS cap in a "real-life" clinic population measured as the % of required applications completed	Week 4
Secondary	The % Change From Baseline to Week 4 (or End of Treatment) in the IGA.	Investigator Global Assessment: Investigator's Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick and simple way to quantify disease severity both for clinical studies and in a non-study clinic setting. Score ranges from '0' = clear or "No inflammatory signs of AD" to '4' = Very Severe Disease with "severe erythema and severe papulation/infiltration with oozing/crusting."	Week 4
Secondary	EASI	Eczema Area and Severity Index (EASI): Disease severity will be assessed by a physician with the Eczema Area and Severity Index (EASI). This measure is commonly used and well validated instrument of eczema severity. It is weighted for area in each of the four body regions (which differs for adults and children under 7) and scores erythema, excoriation, induration/papulation, and lichenification. The total scores range from 0-72. Higher scores represent more severe eczema.	Week 4