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

NCT03351114 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Pro00086947
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Morphea

Keywords

Morphea, Localized Scleroderma

Outcome Measures

Primary Outcomes (1)

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

  Change in dermal thickness on skin biopsy. A sentinel plaque will be selected at baseline. A 4 mm skin punch biopsy will be performed at baseline and at 12 weeks, on the same affected plaque.

  Baseline, 12 weeks

Secondary Outcomes (4)

• Percentage of Reduction in DIET Score of Sentinel Plaque

  Baseline and 12 weeks

• Percentage of Reduction in LoSCAT Score

  Baseline,12 weeks

• Percentage of Reduction in Skindex-29 Score

  Baseline and 12 weeks

• Change in Dermal Thickness of Sentinel Plaque by Ultrasonography

  Baseline, 4, 8 and 12 weeks, optional at 20 weeks

Study Arms (1)

Crisaborole 2% ointment

EXPERIMENTAL

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

Drug: Crisaborole

Interventions

Crisaborole DRUG

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

Also known as: Eucrisa

Crisaborole 2% ointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 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
• Able to give informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Pfizer: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Scleroderma, Localized

Interventions

crisaborole

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Dr. Adela R. Cardones
• Organization: Duke University

adela.cardones@duke.edu

9196843110

Study Officials

• Adela Cardones, MD

  Duke UMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 22, 2017
• Study Start: September 1, 2018
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: April 1, 2021
• Results First Posted: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)