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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
hydrocortisone 17-butyrate 0.1% Cream preparation
hydrocortisone 17-butyrate 0.1% Ointment preparation
hydrocortisone 17-butyrate 0.1% Lipocream preparation
Sponsored by
Wake Forest University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wake Forest University Health Sciences Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Cream-

Ointment

Lipocream

Arm Description

topical hydrocortisone 17-butyrate 0.1% Cream preparation applied twice daily to all lesions of atopic dermatitis

topical hydrocortisone 17-butyrate 0.1% Ointment preparation applied twice daily to all lesions of atopic dermatitis

topical hydrocortisone 17-butyrate 0.1% Lipocream preparation applied twice daily to all lesions of atopic dermatitis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 5, 2008
Last Updated
August 9, 2018
Sponsor
Wake Forest University
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1. Study Identification

Unique Protocol Identification Number
NCT00693693
Brief Title
Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis
Official Title
Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cream-
Arm Type
Active Comparator
Arm Description
topical hydrocortisone 17-butyrate 0.1% Cream preparation applied twice daily to all lesions of atopic dermatitis
Arm Title
Ointment
Arm Type
Active Comparator
Arm Description
topical hydrocortisone 17-butyrate 0.1% Ointment preparation applied twice daily to all lesions of atopic dermatitis
Arm Title
Lipocream
Arm Type
Active Comparator
Arm Description
topical hydrocortisone 17-butyrate 0.1% Lipocream preparation applied twice daily to all lesions of atopic dermatitis
Intervention Type
Drug
Intervention Name(s)
hydrocortisone 17-butyrate 0.1% Cream preparation
Other Intervention Name(s)
Locoid
Intervention Description
Apply medication twice a day to affected areas of atopic dermatitis
Intervention Type
Drug
Intervention Name(s)
hydrocortisone 17-butyrate 0.1% Ointment preparation
Other Intervention Name(s)
locoid
Intervention Description
Apply medication twice a day to affected areas of atopic dermatitis
Intervention Type
Drug
Intervention Name(s)
hydrocortisone 17-butyrate 0.1% Lipocream preparation
Other Intervention Name(s)
locoid
Intervention Description
Apply medication twice a day to affected areas of atopic dermatitis
Primary Outcome Measure Information:
Title
Adherence to Locoid
Description
Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Feldman, MD, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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