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Measuring Adherence to Topical Therapy in Children With Atopic Dermatitis and the Impact of a Return Visit
This study is currently recruiting participants.
Study NCT00654355   Information provided by Wake Forest University
First Received: April 2, 2008   Last Updated: January 9, 2009   History of Changes

April 2, 2008
January 9, 2009
April 2008
September 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00654355 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
 
Measuring Adherence to Topical Therapy in Children With Atopic Dermatitis and the Impact of a Return Visit
Measuring Adherence to Topical Therapy in Children With Atopic Dermatitis and the Impact of a Return Visit

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

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.

Phase IV
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment
Atopic Dermatitis
Drug: tacrolimus ointment
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
30
 
September 2009   (final data collection date for primary outcome measure)

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.
Both
2 Years to 15 Years
No
Contact: Susie Dowd 336-716-3775 sdowd@wfubmc.edu
United States
 
NCT00654355
Dr .Steve Feldman, Wake Forest University Health Sciences
00002300, contract #32417
Wake Forest University
 
Principal Investigator: Steve Feldman, MD, PHD WFUHS
Wake Forest University
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP