| 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 ]
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- 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 ]
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| |
| 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 |
| |
| |
| |
| Recruiting |
| 30 |
|
| September 2009 (final data collection date for primary outcome measure) |
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.
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| Both |
| 2 Years to 15 Years |
| No |
|
|
| United States |
| |
| NCT00654355 |
| Dr .Steve Feldman, Wake Forest University Health Sciences |
| 00002300, contract #32417 |
| Wake Forest University |
|
| Principal Investigator: |
Steve Feldman, MD, PHD |
WFUHS |
|
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| Wake Forest University |
| January 2009 |