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

This study is not yet open for participant recruitment.
Verified by Wake Forest University, April 2008

Sponsored by: 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

ChemIDplus related topics:   Tacrolimus    Tacrolimus anhydrous   

U.S. FDA Resources

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

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 2008 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: tacrolimus ointment
    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:

  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.
  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    
      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


Responsible Party:   Wake Forest University Health Sciences ( Dr .Steve Feldman )
Study ID Numbers:   00002300, contract #32417
First Received:   April 2, 2008
Last Updated:   April 7, 2008
ClinicalTrials.gov Identifier:   NCT00654355
Health Authority:   United States: Institutional Review Board

Keywords provided by Wake Forest University:
atopic dermatitis  
eczema  

Study placed in the following topic categories:
Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Tacrolimus
Eczema
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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