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A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Children (Ages ≥ 2 Years to < 12 Years) With Atopic Dermatitis

Atopic Dermatitis (AD): Phase 3 double-blinded study, 8 week study with 44 week long-term safety period with guaranteed study medicine. Topical cream. Male and females ≥ 2 Years to < 12 Years with AD Atopic Dermatitis (AD), also known as eczema, is an inflammatory skin condition that can reoccur repeatedly. AD often causes itching and burning, skin flaking, and red bumps that can crust and open up. The purpose of this study is to find out of the study medicine, ruxolitinib cream, can help with the treatment of AD.

Participants in this research study will need to return to the research site for up to 17 visits over 61 weeks. At this visits, participants will be asked to complete questionnaires, undergo blood draws, complete photography, and undergo physical and skin exams.

Up to $850.00

Yes
 

Andrea Zaenglein
Samantha Gettle - at sgettle2@pennstatehealth.psu.edu or 717-531-5136
Dermatology (HERSHEY)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT04921969
STUDY00018410
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Inclusion Criteria:
AD present for at least 3 months
AD covering between 3% and 20% body surface
Willing to follow all study guidelines

Exclusion Criteria:
Certain treatments for AD are not allowed; coordinator will discuss specific treatments
Positive for Hepatitis B, Hepatitis C, or HIV
Previous treatment with JAK inhibitors
Skin Conditions
Experimental drug compared to a placebo/”sugar pill”
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See this study on ClinicalTrials.gov
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Location Contacts
Hershey, PA ,