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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

Page last updated: August 23, 2015

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