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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693693
• Other study ID #: IRB00000702
• Status: Completed
• Phase: Phase 4
• Start date: November 2006
• Est. completion date: September 2008

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• hydrocortisone 17-butyrate 0.1% Cream preparation
Apply medication twice a day to affected areas of atopic dermatitis
• hydrocortisone 17-butyrate 0.1% Ointment preparation
Apply medication twice a day to affected areas of atopic dermatitis
• hydrocortisone 17-butyrate 0.1% Lipocream preparation
Apply medication twice a day to affected areas of atopic dermatitis

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences Dermatology	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to Locoid	Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied	2 weeks