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

NCT03351114

Last updated date
Study Location
Duke University
Durham, North Carolina, 27710, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Morphea
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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hCG at any time during the study will be withdrawn from the study.

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MorpheaPilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea
NCT03351114
  1. Durham, North Carolina
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
 (submitted: August 13, 2020)
8
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2017)
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:

  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: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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Adela Cardones, MDDuke UMC
PRS Account Duke University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP