Status:
COMPLETED
Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea
Lead Sponsor:
Duke University
Collaborating Sponsors:
Pfizer
Conditions:
Morphea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a pilot study to determine the safety and clinical efficacy of crisaborole 2% ointment in the treatment of morphea.
Detailed Description
A Phase 2, pilot, proof-of-concept, open label, single arm prospective study to assess the safety, tolerability and efficacy of using crisaborole 2% ointment for adult morphea. Patients identified by ...
Eligibility Criteria
Inclusion
- \>= 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
- 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 Women with a positive urine hCG at any time during the study will be withdrawn from the study.
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03351114
Start Date
September 1 2018
End Date
March 10 2020
Last Update
April 1 2021
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27710