CompletedPhase 2

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

United States8 participantsStarted 2018-09-01

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. \>= 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

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 Women with a positive urine hCG at any time during the study will be withdrawn from the study.

Number of Participants Who Had a Reduction in Dermal Thickness of Sentinel Plaque

Timeframe: Baseline, 12 weeks

NCT IDNCT03351114

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-10

Results submitted2021-03-10