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Topical PDE4 Inhibitor for Morphea - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if crisaborole 2% will soften the skin with scleroderma and to see if it can be a safe and helpful treatment for morphea.

What is the Condition Being Studied?

Morphea

Who Can Participate in the Study?

Adults who:
- Have morphea
- Are not on a treatment to make your immune system work better. (If you are on this treatment, you are willing to stop immune system treatment right before and during the study.)
- Do not have a kidney disease
- Are not pregnant

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Have 4 visits in 12 weeks
- Have the option to have a 5th visit at 20 weeks
- Be asked to apply crisaborole 2% ointment to your morphea 2 times a day for 12 weeks
- Have your skin looked at by the study doctor
- Answer questionnaires
- Have a sample of skin tissue taken from part of your morphea
- Have a skin ultrasound
- Have your morphea photographed

Study Details

Full Title
Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea
Principal Investigator
Protocol Number
IRB:PRO00086947
NCT:NCT03351114
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698