Study of Crisaborole Ointment 2% in Mild to Moderate Atopic Dermatitis
NCT04214197
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
6177265066
Adult Trials: 18+ Years
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).
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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Chicago, Illinois
- Charleston, South Carolina
- Boston, Massachusetts
| 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 | 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:
Exclusion Criteria:
| ||||||||
| Sex/Gender ICMJE |
| ||||||||
| Ages ICMJE | 2 Years and older (Child, Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
| ||||||||
| 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 |
| ||||||||
| IPD Sharing Statement ICMJE |
| ||||||||
| 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 | |||||||||