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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04214197
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Gideon Piers Smith, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Crisaborole 2% Top Oint Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Photo Documentation Study of Crisaborole Ointment 2% in Mild to Moderate Atopic Dermatitis
Estimated Study Start Date : December 20, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Crisaborole

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Time to success (in days) on ISGA [ Time Frame: Through study completion, an average of 4 weeks ]
    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.

  2. Time to success (by week) on ISGA [ Time Frame: Through study completion, an average of 4 weeks ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04214197


Contacts
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Contact: Gideon P Smith, MD 6177265066 harvardskinstudies@partners.org
Contact: Elvida Y Arias 6177265066 harvardskinstudies@partners.org

Locations
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United States, Massachusetts
MGH Clinical Unit for Research Trials in Skin (CURTIS) Recruiting
Boston, Massachusetts, United States, 02114
Contact: Elvida Arias    617-726-5066    harvardskinstudies@partners.org   
Principal Investigator: Gideon Smith, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Pfizer
Additional Information:
Publications:
Defining a responder on the Peak Pruritus Numerical Rating Scale (NRS) in patients with moderate-to-severe atopic dermatitis: Detailed analysis from randomized trials of dupilumab. Journal of the American Academy of Dermatology. 2017;76(6):AB93.

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Responsible Party: Gideon Piers Smith, Associate Director, CURTIS, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04214197    
Other Study ID Numbers: 2019P002349
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases