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 School of Medicine.
Recruitment status was Recruiting
Information provided by:
Wake Forest School of Medicine
First received: April 2, 2008
Last updated: January 9, 2009
Last verified: January 2009
The purpose of this research study is to better understand how the study drug works when people use it to treat atopic dermatitis.
Drug: tacrolimus ointment
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Measuring Adherence to Topical Therapy in Children With Atopic Dermatitis and the Impact of a Return Visit
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:
| Study Start Date:
| Estimated Primary Completion Date:
||September 2009 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||2 Years to 15 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654355
|Dept of Dermatology, WFUHS
|Winston Salem, North Carolina, United States, 27157 |
|Contact: Adele Clark, PA-C 336-716-3775 firstname.lastname@example.org |
|Principal Investigator: Steve R Feldman, MD, PHD |
Wake Forest School of Medicine
||Steve Feldman, MD, PHD
No publications provided
||Dr .Steve Feldman, Wake Forest University Health Sciences
History of Changes
|Other Study ID Numbers:
||00002300, contract #32417
|Study First Received:
||April 2, 2008
||January 9, 2009
||United States: Institutional Review Board
Keywords provided by Wake Forest School of Medicine:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 25, 2014
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Immune System Diseases
Physiological Effects of Drugs