Expired Study
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Winston-Salem, North Carolina 27157


Purpose:

The purpose of this research study is to better understand adherence to Locoid when people use it to treat atopic dermatitis.


Study summary:

An investigator-blinded prospective study of subjects with mild to moderate atopic dermatitis (>5% Body Surface area and 2 or 3 on the Investigator Global Assessment (IGA) scale). The drug will be used within FDA-approved labeling. Subjects will be randomized to each of the following topical hydrocortisone 17-butyrate 0.1% preparations— ointment, cream or lipocream— in the manufacturer's original tube fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened and this data can be downloaded and tabulated with the associated software. The study will consist of a 2-week Treatment Phase (visits at Baseline and Week 2). Subjects will be instructed to apply the medication twice daily (morning and evening) for 2 weeks to all of their AD lesions. Adherence will be measured by MEMs cap.


Criteria:

Inclusion Criteria: - Male or female ≥ 18 years of age. - Subjects must have diagnosis of mild to moderate atopic dermatitis using IGA criteria. (2 or 3 on severity scale) - Subjects must have >5% TBSA and <30% to be enrolled. - Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control. Exclusion Criteria: - Known allergy or sensitivity to topical Locoid® cream, ointment or lipocream in the subject. - Inability to complete all study-related visits. - Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study. - Requiring >130 gm of cream in a 2 week period. - Having facial or groin involvement of their disease. - Pregnant women and women who are breast feeding are to be excluded. Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.


NCT ID:

NCT00693693


Primary Contact:

Principal Investigator
Steve Feldman, MD, PhD
Wake Forest University Health Sciences


Backup Contact:

N/A


Location Contact:

Winston-Salem, North Carolina 27157
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2018

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