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

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

Detailed Description
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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.

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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: hydrocortisone 17-butyrate 0.1% Cream preparation
* Drug: hydrocortisone 17-butyrate 0.1% Ointment preparation
* Drug: hydrocortisone 17-butyrate 0.1% Lipocream preparation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cream-<br>topical hydrocortisone 17-butyrate 0.1% Cream preparation applied twice daily to all lesions of atopic dermatitis | Drug: hydrocortisone 17-butyrate 0.1% Cream preparation<br>* Apply medication twice a day to affected areas of atopic dermatitis<br>* Other names: Locoid;|
| Active Comparator: Ointment<br>topical hydrocortisone 17-butyrate 0.1% Ointment preparation applied twice daily to all lesions of atopic dermatitis | Drug: hydrocortisone 17-butyrate 0.1% Ointment preparation<br>* Apply medication twice a day to affected areas of atopic dermatitis<br>* Other names: locoid;|
| Active Comparator: Lipocream<br>topical hydrocortisone 17-butyrate 0.1% Lipocream preparation applied twice daily to all lesions of atopic dermatitis | Drug: hydrocortisone 17-butyrate 0.1% Lipocream preparation<br>* Apply medication twice a day to affected areas of atopic dermatitis<br>* Other names: locoid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Locoid | Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied | 2 weeks |