Adherence to Topical Hydrocortisone 17-Butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis
Information source: Wake Forest School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atopic Dermatitis
Intervention: hydrocortisone 17-butyrate 0.1% preparation ointment (Drug); hydrocortisone 17-butyrate 0.1% preparation cream (Drug); hydrocortisone 17-butyrate 0.1% preparation lipocream (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Wake Forest School of Medicine Official(s) and/or principal investigator(s):
Steve Feldman, MD, PhD, Principal Investigator, Affiliation: Wake Forest School of Medicine
Summary
The purpose of this research study is to better understand how the study drug Locoid works
when people use it to treat atopic dermatitis.
Clinical Details
Official title: Adherence to Topical Hydrocortisone 17-Butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The change over treatment in the IGA.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Wake Forest University Health Sciences Dermatology, Winston Salem, North Carolina 27157, United States
Additional Information
Starting date: November 2006
Last updated: June 11, 2008
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