Overview

This trial is active, not recruiting.

Condition atopic dermatitis
Treatments hydrocortisone 17-butyrate 0.1% preparation ointment, hydrocortisone 17-butyrate 0.1% preparation cream, hydrocortisone 17-butyrate 0.1% preparation lipocream
Phase phase 4
Sponsor Wake Forest School of Medicine
Start date November 2006
End date September 2008
Trial size 30 participants
Trial identifier NCT00693693, 00000702

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
topical hydrocortisone 17-butyrate 0.1% preparation ointment
hydrocortisone 17-butyrate 0.1% preparation ointment Locoid cream
Apply medication twice a day to affected areas. Moisturize as needed.
(Experimental)
topical hydrocortisone 17-butyrate 0.1% preparation cream
hydrocortisone 17-butyrate 0.1% preparation cream
Apply medication twice a day to affected areas. Moisturize as needed.
(Experimental)
topical hydrocortisone 17-butyrate 0.1% preparation lipocream
hydrocortisone 17-butyrate 0.1% preparation lipocream
Apply medication twice a day to affected areas. Moisturize as needed.

Primary Outcomes

Measure
The change over treatment in the IGA.
time frame: 2 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Adherence to Topical Hydrocortisone 17-Butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis
Principal investigator Steve Feldman, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2008.
Information provided to ClinicalTrials.gov by Wake Forest School of Medicine.