Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea
NCT03351114
ABOUT THIS STUDY
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Contact a representative by phone, email, or visiting the study website. Please see the references below:
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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.
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hCG at any time during the study will be withdrawn from the study.
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Descriptive Information | |||||||
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Brief Title ICMJE | Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea | ||||||
Official Title ICMJE | Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea | ||||||
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 their physician, nurse, or other member of their clinical care team as meeting criteria for the study will be asked to apply crisaborole 2% ointment, twice daily, on affected plaques for 12 weeks. A 4 mm skin punch biopsy will be performed at baseline and at 12 weeks, on the same affected plaque. Dermal thickness will be measured and compared before and at the end of treatment. Patients will have a clinical assessment at baseline and at weeks 4, 8 and 12. After week 12, patients who need further treatment will undergo standard of care treatment as determined by their primary dermatologist. Physician and patient reported assessment and skin imaging will be performed at baseline, week 4, 8 and 12, and at week 20. Photography will also be performed at baseline and week 12. An optional post treatment follow-up will be performed at week 20. Medication will be provided free of charge by Pfizer, as part of the grant that is funding this study. These will be dispensed by the study group at baseline and during the subsequent clinic visits. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Morphea | ||||||
Intervention ICMJE | Drug: Crisaborole
Apply Crisaborole 2% ointment to affected skin twice per day. Other Name: Eucrisa | ||||||
Study Arms ICMJE | Experimental: Crisaborole 2% ointment
Crisaborole 2% ointment applied to affected skin twice per day. Intervention: Drug: Crisaborole | ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 8 | ||||||
Original Estimated Enrollment ICMJE | 20 | ||||||
Actual Study Completion Date ICMJE | March 10, 2020 | ||||||
Actual Primary Completion Date | March 10, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:Subjects fulfilling any of the following criteria are not eligible for inclusion in this study.
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03351114 | ||||||
Other Study ID Numbers ICMJE | Pro00086947 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Duke University | ||||||
Study Sponsor ICMJE | Duke University | ||||||
Collaborators ICMJE | Pfizer | ||||||
Investigators ICMJE |
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PRS Account | Duke University | ||||||
Verification Date | March 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |