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Dupilumab in Atopic Dermatitis - Clinical Trial

What is the Purpose of this Study?

The purpose of this study is to learn how Dupilumab affects the germs on your skin, water loss on your skin, and your immune system.
What is the Condition Being Studied?
Atopic Dermatitis; Eczema

Who Can Participate in the Study?

Adults:
-18-65 years old
-Currently have least 3 spots of atopic dermatitis on your body
-Have used atopic dermatitis drugs on your skin in the past

Age Group
Adults

What is Involved?

There are two parts to this study.

Part One
If you choose to join this study, you will:
- Be randomized (like the flip of a coin) to either get a shot of the study drug (Dupilumab) or a shot without the drug
-Come to the clinic on days 1,3,and 7 and weeks 2, 3, 4 and 6 for:
---Shots in the muscle
---Exams
---Questionnaires
---Blood draws
---Skin swabs

Part 2
-Both groups are now assigned to get the Dupilumab (study drug) shot every other week for 10 weeks
-- Be taught how to give yourself the shot every other week (or you can come in to have a medical professional do it)
---Come to the clinic for the same as before on weeks 11, and 16
-Complete a 30 minute phone call with the staff on week 16

Study Details

Full Title
Effect of Dupilumab (anti-IL4Ra) on the Host-Microbe Interface in Atopic Dermatitis
Principal Investigator
Protocol Number
IRB: PRO00100287
NCT: NCT03389893
Phase
Phase IV
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698