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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

Inclusion criteria

. \>= 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

Exclusion criteria

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 Women with a positive urine hCG at any time during the study will be withdrawn from the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline, 12 weeks

Trial details

NCT IDNCT03351114

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-10

Results submitted2021-03-10

View on ClinicalTrials.gov More Morphea trials