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

Wake Forest University (WFU)

Status and phase: Completed; Phase 4

Conditions: Atopic Dermatitis

Treatments: Drug: hydrocortisone 17-butyrate 0.1% Lipocream preparation; Drug: hydrocortisone 17-butyrate 0.1% Ointment preparation; Drug: hydrocortisone 17-butyrate 0.1% Cream preparation

Study type: Interventional

Funder types: Other

Identifiers

NCT00693693

IRB00000702

Details and patient eligibility

About

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

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 3 patient groups

Cream-

Active Comparator group

Description:

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

Treatment:

Drug: hydrocortisone 17-butyrate 0.1% Cream preparation

Ointment

Active Comparator group

Description:

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

Treatment:

Drug: hydrocortisone 17-butyrate 0.1% Ointment preparation

Lipocream

Active Comparator group

Description:

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

Treatment:

Drug: hydrocortisone 17-butyrate 0.1% Lipocream preparation