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

• Status: Completed
• Trial end date: 2020-03-10
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Pfizer
• Treatments: Phosphodiesterase 4 Inhibitors

Criteria

Inclusion Criteria:

1. >= 18 years of age

2. Clinical diagnosis of morphea.

3. <20% Total body surface area involvement.

4. Does not require systemic immunosuppressive therapy for morphea.

5. No immunosuppressive systemic therapy 1 month prior to starting the study (methotrexate, mycophenolate mofetil, azathioprine, cyclosporine, cyclophosphamide, prednisone >=10 mg PO daily).

6. No immunomodulating topical therapy (topical steroids or topical calcineurin inhibitor), and no topical vitamin D analogue, 2 weeks prior to starting study.

7. No allergy to crisaborole or vehicle.

8. No known renal disease

9. Able to give informed consent.

Exclusion Criteria:Subjects fulfilling any of the following criteria are not eligible for inclusion in this study.

1. Clinical diagnosis of depression or history of suicidal ideation.

2. 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 Women with a positive urine hCG at any time during the study will be withdrawn from the study.