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

• ClinicalTrials.gov Identifier: NCT00693693
• Recruitment Status: Completed
• First Posted: June 9, 2008
• Results First Posted: March 17, 2017
• Last Update Posted: September 10, 2018
• Sponsor: Wake Forest University
• Information provided by (Responsible Party): Wake Forest University Health Sciences ( Wake Forest University )

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.

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: hydrocortisone 17-butyrate 0.1% Cream preparation; Drug: hydrocortisone 17-butyrate 0.1% Ointment preparation; Drug: hydrocortisone 17-butyrate 0.1% Lipocream preparation	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis
• Study Start Date: November 2006
• Actual Primary Completion Date: September 2008
• Actual Study Completion Date: September 2008

Arms and Interventions

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 Name: 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 Name: 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 Name: locoid

Outcome Measures

Primary Outcome Measures :

1. Adherence to Locoid [ Time Frame: 2 weeks ]
   Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, North Carolina

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University

Investigators

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

More Information

• Responsible Party: Wake Forest University
• ClinicalTrials.gov Identifier: NCT00693693
• Other Study ID Numbers: IRB00000702
• First Posted: June 9, 2008
• Results First Posted: March 17, 2017
• Last Update Posted: September 10, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Hydrocortisone-17-butyrate; Anti-Inflammatory Agents; Dermatologic Agents