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

NCT04214197

Last updated date
Study Location
MGH Clinical Unit for Research Trials in Skin (CURTIS)
Boston, Massachusetts, 02114, United States
Contact
6177265066

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

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


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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Crisaborole Ointment 2% in Mild to Moderate Atopic Dermatitis
Official Title  ICMJE An Open Label, Photo Documentation Study of Crisaborole Ointment 2% in Mild to Moderate Atopic Dermatitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Drug: Crisaborole 2% Top Oint
Publications *

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 27, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2022
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gideon P Smith, MD6177265066[email protected]
Contact: Elvida Y Arias6177265066[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04214197
Other Study ID Numbers  ICMJE 2019P002349
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 Gideon Piers Smith, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account Massachusetts General Hospital
Verification Date September 2020

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