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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2009 by Wake Forest University. Recruitment status was Recruiting

First Received on April 2, 2008. Last Updated on January 9, 2009 History of Changes

Sponsor:	Wake Forest University
Information provided by:	Wake Forest University
ClinicalTrials.gov Identifier:	NCT00654355

Purpose

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

Condition	Intervention	Phase
Atopic Dermatitis	Drug: tacrolimus ointment	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Measuring Adherence to Topical Therapy in Children With Atopic Dermatitis and the Impact of a Return Visit

Resource links provided by NLM:

Drug Information available for: Tacrolimus anhydrous Tacrolimus

U.S. FDA Resources

Further study details as provided by Wake Forest University:

Primary Outcome Measures:

Measured adherence to topical therapy in children via MEMS cap in a "real-life" clinic population [ Time Frame: from Baseline to Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The change from Baseline to Week 4 (or end of treatment) in the IGA. [ Time Frame: from Baseline to Week 4 ] [ Designated as safety issue: No ]
The change from Baseline to Week 4 (or end of treatment) in the calculated EASI score. [ Time Frame: from Baseline to Week 4 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	April 2008
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	2 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654355

Contacts

Contact: Susie Dowd

336-716-3775

sdowd@wfubmc.edu

Locations

United States, North Carolina
Dept of Dermatology, WFUHS	Recruiting
Winston Salem, North Carolina, United States, 27157
Contact: Adele Clark, PA-C 336-716-3775 adclark@wfubmc.edu
Principal Investigator: Steve R Feldman, MD, PHD

Sponsors and Collaborators

Wake Forest University

Investigators

Principal Investigator:

Steve Feldman, MD, PHD

WFUHS

More Information

No publications provided

Responsible Party:	Dr .Steve Feldman, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:	NCT00654355 History of Changes
Other Study ID Numbers:	00002300, contract #32417
Study First Received:	April 2, 2008
Last Updated:	January 9, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Wake Forest University:

atopic dermatitis
eczema

Additional relevant MeSH terms:

Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate

Hypersensitivity
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012