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

Phase 4

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: hydrocortisone 17-butyrate 0.1% Ointment preparation; Drug: hydrocortisone 17-butyrate 0.1% Cream preparation; Drug: hydrocortisone 17-butyrate 0.1% Lipocream preparation

• Registration Number: NCT00693693
• Lead Sponsor: Wake Forest University

Brief 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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-06
• Study First Posted: 2008-06-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2017-01-27
• Results First Submitted QC: 2017-01-27
• Results First Posted: 2017-03-17
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ointment	hydrocortisone 17-butyrate 0.1% Ointment preparation	topical hydrocortisone 17-butyrate 0.1% Ointment preparation applied twice daily to all lesions of atopic dermatitis
Cream-	hydrocortisone 17-butyrate 0.1% Cream preparation	topical hydrocortisone 17-butyrate 0.1% Cream preparation applied twice daily to all lesions of atopic dermatitis
Lipocream	hydrocortisone 17-butyrate 0.1% Lipocream preparation	topical hydrocortisone 17-butyrate 0.1% Lipocream preparation applied twice daily to all lesions of atopic dermatitis

Primary Outcome Measures

Name	Time	Method
Adherence to Locoid	2 weeks	Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied

Trial Locations

Locations (1)

Wake Forest University Health Sciences Dermatology; 🇺🇸 Winston-Salem, North Carolina, United States