A Study Evaluating the Efficacy of Fluocinonide Cream 0.1% (Vanos) in Subjects With Atopic Dermatitis

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to better understand how fluocinonide cream 0.1% (Vanos®) works when people use it to treat atopic dermatitis for just a few days.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences; Wake Forest University Health Sciences need to be deleted
• Collaborator: Medicis Pharmaceutical Corporation
• Treatments: Fluocinonide

Criteria

Inclusion Criteria:

• Male or female with mild to severe atopic dermatitis, 12 years of age or older, that agree to participate and provide written consent (and assent if applicable)

• Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating of 2 - 4 in the Investigator Global Assessment (Appendix B))

• Percentage of overall body surface are of involvement (BSA) must be ≥2%

• 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:

• Use within 4 weeks of baseline of systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids

• Application or use within 2 weeks of baseline of topical corticosteroid medications or topical anti-inflammatory medication, which may influence study outcome

• Presence of a concurrent medical condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments

• Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study

• Amount of disease involvement that would require >60 gm of cream in a 1 week period

• Subjects with known allergy or sensitivity to topical Vanos™ cream or components

• Pregnant women and women who are breastfeeding are to be excluded. Women of childbearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.