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

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

tacrolimus ointment

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, eczema

Eligibility Criteria

2 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Dept of Dermatology, WFUHS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active Drug

Arm Description

tacrolimus ointment

Outcomes

Primary Outcome Measures

Adherence

adherence to topical therapy in children via MEMS cap in a "real-life" clinic population measured as the % of required applications completed

Secondary Outcome Measures

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."

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.

Full Information

NCT ID

NCT00654355

First Posted

April 2, 2008

Last Updated

July 3, 2018

Sponsor

Wake Forest University

1. Study Identification

Unique Protocol Identification Number

NCT00654355

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

atopic dermatitis, eczema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Drug

Arm Type

Experimental

Arm Description

tacrolimus ointment

Intervention Type

Drug

Intervention Name(s)

tacrolimus ointment

Other Intervention Name(s)

Protopic Ointment

Intervention Description

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

Primary Outcome Measure Information:

Title

Adherence

Description

adherence to topical therapy in children via MEMS cap in a "real-life" clinic population measured as the % of required applications completed

Time Frame

Week 4

Secondary Outcome Measure Information:

Title

The % Change From Baseline to Week 4 (or End of Treatment) in the IGA.

Description

Time Frame

Week 4

Title

EASI

Description

Time Frame

Week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steve Feldman, MD, PHD

Organizational Affiliation

WFUHS

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept of Dermatology, WFUHS

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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