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

Wake Forest University26 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atopic Dermatitis

Interventions

hydrocortisone 17-butyrate 0.1% Cream preparationDRUG

Apply medication twice a day to affected areas of atopic dermatitis

hydrocortisone 17-butyrate 0.1% Ointment preparationDRUG

Apply medication twice a day to affected areas of atopic dermatitis

hydrocortisone 17-butyrate 0.1% Lipocream preparationDRUG

Apply medication twice a day to affected areas of atopic dermatitis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Adherence to Locoid

Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied

Time frame: 2 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.