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

NCT ID: NCT03351114

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2020-03-10

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.

Conditions

Morphea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Crisaborole 2% ointment

Crisaborole 2% ointment applied to affected skin twice per day.

Group Type: EXPERIMENTAL

Crisaborole

Intervention Type: DRUG

Apply Crisaborole 2% ointment to affected skin twice per day.

Interventions

Crisaborole

Apply Crisaborole 2% ointment to affected skin twice per day.

Intervention Type: DRUG

Other Intervention Names

Eucrisa

Eligibility 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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adela Cardones, MD

Role: PRINCIPAL_INVESTIGATOR

Duke UMC

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00086947

Identifier Type: -

Identifier Source: org_study_id