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

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

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: hydrocortisone 17-butyrate 0.1% Cream preparation; Drug: hydrocortisone 17-butyrate 0.1% Ointment preparation; Drug: hydrocortisone 17-butyrate 0.1% Lipocream preparation

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cream-; 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; Apply medication twice a day to affected areas of atopic dermatitis; Other Names: Locoid
Active Comparator: Ointment; 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; Apply medication twice a day to affected areas of atopic dermatitis; Other Names: locoid
Active Comparator: Lipocream; 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; Apply medication twice a day to affected areas of atopic dermatitis; Other Names: locoid

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University
• Investigators: Principal Investigator: Steve Feldman, MD, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: June 5, 2008
• First Submitted That Met QC Criteria: June 6, 2008
• First Posted (Estimate): June 9, 2008

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Anti-Inflammatory Agents; Dermatologic Agents; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Hydrocortisone-17-butyrate
• Other Study ID Numbers: IRB00000702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No