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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00654355
Recruitment Status : Completed
First Posted : April 8, 2008
Results First Posted : June 6, 2017
Last Update Posted : August 1, 2018
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: tacrolimus ointment Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Measuring Adherence to Topical Therapy in Children With Atopic Dermatitis and the Impact of a Return Visit
Study Start Date : April 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: Active Drug
tacrolimus ointment
Drug: tacrolimus ointment
tacrolimus ointment to be applied twice daily to affected areas during duration of study
Other Name: Protopic Ointment

Primary Outcome Measures :
  1. Adherence [ Time Frame: Week 4 ]
    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 :
  1. The % Change From Baseline to Week 4 (or End of Treatment) in the IGA. [ Time Frame: Week 4 ]
    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."

  2. EASI [ Time Frame: Week 4 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00654355

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United States, North Carolina
Dept of Dermatology, WFUHS
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
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Principal Investigator: Steve Feldman, MD, PHD WFUHS
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Responsible Party: Wake Forest University Identifier: NCT00654355    
Other Study ID Numbers: IRB00002300
contract #32417 ( Other Identifier: WakeForest )
First Posted: April 8, 2008    Key Record Dates
Results First Posted: June 6, 2017
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
atopic dermatitis
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action