Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea

Completed · Phase 2

Conditions studied: Morphea

In brief

This is a pilot study to determine the safety and clinical efficacy of crisaborole 2% ointment in the treatment of morphea.

Key facts

Study ID

NCT03351114

Run by

Duke University

People needed

8

Starts

2018-09-01

Expected to finish

2020-03-10

Last updated by the study team

2021-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >= 18 years of age
• Clinical diagnosis of morphea.
• <20% Total body surface area involvement.
• Does not require systemic immunosuppressive therapy for morphea.
• No immunosuppressive systemic therapy 1 month prior to starting the study (methotrexate, mycophenolate mofetil, azathioprine, cyclosporine, cyclophosphamide, prednisone >=10 mg PO daily).
• No immunomodulating topical therapy (topical steroids or topical calcineurin inhibitor), and no topical vitamin D analogue, 2 weeks prior to starting study.
• No allergy to crisaborole or vehicle.
• No known renal disease
• Able to give informed consent.
• Exclusion Criteria:Subjects fulfilling any of the following criteria are not eligible for inclusion in this study.
• Clinical diagnosis of depression or history of suicidal ideation.
• Pregnant or breastfeeding women, with pregnant women being defined as the state of a female after conception until the termination of gestation, confirmed by a positive urine human chorionic gonadotropin (hCG) laboratory test. Women with a positive urine hCG at any time during the study will be withdrawn from the study.

Where it is running

• Duke University — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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