Adherence to Topical Hydrocortisone 17-Butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis
This trial is active, not recruiting.
|Treatments||hydrocortisone 17-butyrate 0.1% preparation ointment, hydrocortisone 17-butyrate 0.1% preparation cream, hydrocortisone 17-butyrate 0.1% preparation lipocream|
|Sponsor||Wake Forest School of Medicine|
|Start date||November 2006|
|End date||September 2008|
|Trial size||30 participants|
|Trial identifier||NCT00693693, 00000702|
The purpose of this research study is to better understand how the study drug Locoid works when people use it to treat atopic dermatitis.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
The change over treatment in the IGA.
time frame: 2 weeks
Male or female participants at least 18 years old.
- 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.
- 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.
|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|
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