Study of Crisaborole Ointment 2% in Mild to Moderate Atopic Dermatitis

February 22, 2021 updated by: Gideon Piers Smith, Massachusetts General Hospital

An Open Label, Photo Documentation Study of Crisaborole Ointment 2% in Mild to Moderate Atopic Dermatitis

The purpose of this study is to document the timing of improvement in atopic dermatitis symptoms and severity following the application of crisaborole ointment 2% in patients 2 years or older with mild to moderate atopic dermatitis. Crisaborole ointment 2% will be applied topically twice daily for four weeks and progress will be assessed by photography and patient-reports.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • MGH Clinical Unit for Research Trials in Skin (CURTIS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is a male or female aged at least 2 years of age.
  2. Subject has confirmed clinical diagnosis of active atopic dermatitis (AD) according to the Hanifin and Rajka criteria.
  3. AD diagnosed at least 6 months prior to the screening visit and severity of disease has been stable for the past month.
  4. Subject has a BSA covered with atopic dermatitis of at least 1% (excluding face, scalp, genitals, groin area) [face, genitals and groin will not for be used photos]
  5. Subject has a global ISGA of mild (2) or moderate (3) at the baseline visit.
  6. Subject must be willing to avoid excessive exposure to natural or artificial ultraviolet radiation.
  7. Women of childbearing potential who are heterosexually active must practice a highly effective method of birth control such as an oral, injected or implanted hormonal methods of contraception, intrauterine device (IUD), spermicidal condom, male partner sterilization (the vasectomized partner should be the sole partner for that subject) or true abstinence. If a female subject's childbearing potential changes after start of the study (e.g., a woman who is not heterosexually active becomes active, a premenarchal woman experiences menarche), she must begin practicing a highly effective method of birth control, as described above.
  8. Women of childbearing potential must have a negative pregnancy test at the baseline visit.
  9. Willingness to participate in medical photography with end use by Pfizer for publication and medical education purposes
  10. Subject and/or parent/ legal guardian has voluntarily signed and dated an informed consent form and assent form, if applicable, approved by Partners Institutional Review Board (IRB) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study (including photography consent).

Exclusion Criteria:

  1. Clinically significant medical disorder, condition, or disease including other dermatologic conditions that may interfere with study assessments and photographs.
  2. Recent psychiatric condition (within the past year) or active suicidal ideation or behavior.
  3. Unstable AD (not having stable severity over the past month).
  4. Significant active infection requiring systemic antibiotics.
  5. Treatment with topical corticosteroids or topical calcineurin inhibitors within 2 weeks of the baseline visit.
  6. Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon gamma, Janus kinase inhibitors, azathioprine, methotrexate, etc.) during the study.
  7. Treatment with biologics within 5 half-lives (if known) or 16 weeks before the baseline visit, whichever is longer.
  8. Subject with any planned surgical or medical procedure that would overlap with study participation from screening through end of study
  9. Currently has a malignancy or has a history of malignancy within 5 years before screening (except for a nonmelanoma skin cancer that has been adequately treated).
  10. Is pregnant, nursing, or planning a pregnancy (women).
  11. Previous failure of efficacy following crisaborole use.
  12. History of angioedema or anaphylaxis to topical products.
  13. Known allergies, hypersensitivity, or intolerance to crisaborole or its components.
  14. Participation in another clinical research study with an investigational drug within 4 weeks before randomization in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Crisaborole
Crisaborole is a low molecular weight benzoxaborole PDE-4 inhibitor for the treatment of mild-to-moderate atopic dermatitis in adults and children 2 years and above. Crisaborole ointment 2% is topically applied as a thin layer twice daily for 4 weeks to all AD lesions.
Drug: Crisaborole 2% Top Oint
Crisaborole is a low molecular weight benzoxaborole PDE-4 inhibitor for the treatment of mild-to-moderate atopic dermatitis in adults and children 2 years and above. Crisaborole ointment 2% is topically applied as a thin layer twice daily for 4 weeks to all AD lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to success (in days) on ISGA
Time Frame: At days 1, 8,15, 21 and 29
Time to success (in days) on ISGA (to clear or almost clear with at least a 2-grade improvement) for intensive group through study completion, an average of 4 weeks, will be summarized by 25th percentile, median, and corresponding 95% CIs via Kaplan-Meier method. Kaplan-Meier plot will be provided as well.
At days 1, 8,15, 21 and 29
Time to success (by week) on ISGA
Time Frame: At days 1, 8,15, 21 and 29
Time to success (by week) on ISGA (to clear or almost clear with at least a 2-grade improvement) for all subjects through study completion, an average of 4 weeks, will be summarized by 25th percentile, median, and corresponding 95% CI via Kaplan-Meier method. Kaplan-Meier plot will be provided as well. (pooled all subjects, at days 1, 8,15, 21 and 29)
At days 1, 8,15, 21 and 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2020

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

December 20, 2019

First Submitted That Met QC Criteria

December 27, 2019

First Posted (Actual)

January 2, 2020

Study Record Updates

Last Update Posted (Actual)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 22, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019P002349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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