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

Tracking Information

First Received Date ^ICMJE

June 5, 2008

Last Updated Date

June 11, 2008

Start Date ^ICMJE

November 2006

Estimated Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The change over treatment in the IGA. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00693693 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Atopic Dermatitis

Intervention ^ICMJE

Drug: hydrocortisone 17-butyrate 0.1% preparation ointment
Drug: hydrocortisone 17-butyrate 0.1% preparation cream
Drug: hydrocortisone 17-butyrate 0.1% preparation lipocream

Study Arms / Comparison Groups

Experimental: topical hydrocortisone 17-butyrate 0.1% preparation ointment
Experimental: topical hydrocortisone 17-butyrate 0.1% preparation cream
Experimental: topical hydrocortisone 17-butyrate 0.1% preparation lipocream

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2008

Estimated Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00693693

Responsible Party

Steven Feldman, Wake Forest University Health Sciences

Study ID Numbers ^ICMJE

00000702

Study Sponsor ^ICMJE

Wake Forest University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Steve Feldman, MD, PhD

Wake Forest University

Information Provided By

Wake Forest University

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP