NCT00693693

Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Wake Forest University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	hydrocortisone 17-butyrate 0.1% Cream preparation	Apply medication twice a day to affected areas of atopic dermatitis
DRUG	hydrocortisone 17-butyrate 0.1% Ointment preparation	Apply medication twice a day to affected areas of atopic dermatitis
DRUG	hydrocortisone 17-butyrate 0.1% Lipocream preparation	Apply medication twice a day to affected areas of atopic dermatitis

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-06-09
• Last updated: 2018-09-10
• Results posted: 2017-03-17

Locations

1 site across 1 country: United States