Study of Crisaborole Ointment 2% in Mild to Moderate Atopic Dermatitis
An Open Label, Photo Documentation Study of Crisaborole Ointment 2% in Mild to Moderate Atopic Dermatitis
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 4
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- MGH Clinical Unit for Research Trials in Skin (CURTIS)
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject is a male or female aged at least 2 years of age.
- Subject has confirmed clinical diagnosis of active atopic dermatitis (AD) according to the Hanifin and Rajka criteria.
- AD diagnosed at least 6 months prior to the screening visit and severity of disease has been stable for the past month.
- 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]
- Subject has a global ISGA of mild (2) or moderate (3) at the baseline visit.
- Subject must be willing to avoid excessive exposure to natural or artificial ultraviolet radiation.
- 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.
- Women of childbearing potential must have a negative pregnancy test at the baseline visit.
- Willingness to participate in medical photography with end use by Pfizer for publication and medical education purposes
- 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:
- Clinically significant medical disorder, condition, or disease including other dermatologic conditions that may interfere with study assessments and photographs.
- Recent psychiatric condition (within the past year) or active suicidal ideation or behavior.
- Unstable AD (not having stable severity over the past month).
- Significant active infection requiring systemic antibiotics.
- Treatment with topical corticosteroids or topical calcineurin inhibitors within 2 weeks of the baseline visit.
- 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.
- Treatment with biologics within 5 half-lives (if known) or 16 weeks before the baseline visit, whichever is longer.
- Subject with any planned surgical or medical procedure that would overlap with study participation from screening through end of study
- 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).
- Is pregnant, nursing, or planning a pregnancy (women).
- Previous failure of efficacy following crisaborole use.
- History of angioedema or anaphylaxis to topical products.
- Known allergies, hypersensitivity, or intolerance to crisaborole or its components.
- Participation in another clinical research study with an investigational drug within 4 weeks before randomization in this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Time to success (in days) on ISGA
Time Frame: At days 1, 8,15, 21 and 29
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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.
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At days 1, 8,15, 21 and 29
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Time to success (by week) on ISGA
Time Frame: At days 1, 8,15, 21 and 29
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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)
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At days 1, 8,15, 21 and 29
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Publications and helpful links
General Publications
- Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
- Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016 Mar 12;387(10023):1109-1122. doi: 10.1016/S0140-6736(15)00149-X. Epub 2015 Sep 13.
- Paller AS, Tom WL, Lebwohl MG, Blumenthal RL, Boguniewicz M, Call RS, Eichenfield LF, Forsha DW, Rees WC, Simpson EL, Spellman MC, Stein Gold LF, Zaenglein AL, Hughes MH, Zane LT, Hebert AA. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016 Sep;75(3):494-503.e6. doi: 10.1016/j.jaad.2016.05.046. Epub 2016 Jul 11. Erratum In: J Am Acad Dermatol. 2017 Apr;76(4):777.
- Richard MA, Corgibet F, Beylot-Barry M, Barbaud A, Bodemer C, Chaussade V, D'Incan M, Joly P, Leccia MT, Meurant JM, Petit A, Geffroy BR, Sei JF, Taieb C, Misery L, Ezzedine K. Sex- and age-adjusted prevalence estimates of five chronic inflammatory skin diseases in France: results of the > study. J Eur Acad Dermatol Venereol. 2018 Nov;32(11):1967-1971. doi: 10.1111/jdv.14959. Epub 2018 Jul 16.
- Deckers IA, McLean S, Linssen S, Mommers M, van Schayck CP, Sheikh A. Investigating international time trends in the incidence and prevalence of atopic eczema 1990-2010: a systematic review of epidemiological studies. PLoS One. 2012;7(7):e39803. doi: 10.1371/journal.pone.0039803. Epub 2012 Jul 11.
- Silverberg JI. Public Health Burden and Epidemiology of Atopic Dermatitis. Dermatol Clin. 2017 Jul;35(3):283-289. doi: 10.1016/j.det.2017.02.002. Epub 2017 Apr 22.
- Siegfried EC, Jaworski JC, Hebert AA. Topical calcineurin inhibitors and lymphoma risk: evidence update with implications for daily practice. Am J Clin Dermatol. 2013 Jun;14(3):163-78. doi: 10.1007/s40257-013-0020-1.
- Castellsague J, Kuiper JG, Pottegard A, Anveden Berglind I, Dedman D, Gutierrez L, Calingaert B, van Herk-Sukel MP, Hallas J, Sundstrom A, Gallagher AM, Kaye JA, Pardo C, Rothman KJ, Perez-Gutthann S. A cohort study on the risk of lymphoma and skin cancer in users of topical tacrolimus, pimecrolimus, and corticosteroids (Joint European Longitudinal Lymphoma and Skin Cancer Evaluation - JOELLE study). Clin Epidemiol. 2018 Mar 13;10:299-310. doi: 10.2147/CLEP.S146442. eCollection 2018.
- Gantner F, Gotz C, Gekeler V, Schudt C, Wendel A, Hatzelmann A. Phosphodiesterase profile of human B lymphocytes from normal and atopic donors and the effects of PDE inhibition on B cell proliferation. Br J Pharmacol. 1998 Mar;123(6):1031-8. doi: 10.1038/sj.bjp.0701688.
- Chan SC, Reifsnyder D, Beavo JA, Hanifin JM. Immunochemical characterization of the distinct monocyte cyclic AMP-phosphodiesterase from patients with atopic dermatitis. J Allergy Clin Immunol. 1993 Jun;91(6):1179-88. doi: 10.1016/0091-6749(93)90321-6.
- Tom WL, Van Syoc M, Chanda S, Zane LT. Pharmacokinetic Profile, Safety, and Tolerability of Crisaborole Topical Ointment, 2% in Adolescents with Atopic Dermatitis: An Open-Label Phase 2a Study. Pediatr Dermatol. 2016 Mar-Apr;33(2):150-9. doi: 10.1111/pde.12780. Epub 2016 Jan 18.
- Murrell DF, Gebauer K, Spelman L, Zane LT. Crisaborole Topical Ointment, 2% in Adults With Atopic Dermatitis: A Phase 2a, Vehicle-Controlled, Proof-of-Concept Study. J Drugs Dermatol. 2015 Oct;14(10):1108-12.
- 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.
- Yosipovitch G, Reaney M, Mastey V, Eckert L, Abbe A, Nelson L, Clark M, Williams N, Chen Z, Ardeleanu M, Akinlade B, Graham NMH, Pirozzi G, Staudinger H, Plaum S, Radin A, Gadkari A. Peak Pruritus Numerical Rating Scale: psychometric validation and responder definition for assessing itch in moderate-to-severe atopic dermatitis. Br J Dermatol. 2019 Oct;181(4):761-769. doi: 10.1111/bjd.17744. Epub 2019 May 1.
- Olsen JR, Gallacher J, Finlay AY, Piguet V, Francis NA. Quality of life impact of childhood skin conditions measured using the Children's Dermatology Life Quality Index (CDLQI): a meta-analysis. Br J Dermatol. 2016 Apr;174(4):853-61. doi: 10.1111/bjd.14361. Epub 2016 Mar 6.
- Mirfeizi M, Jafarabadi MA, Toorzani ZM, Mohammadi SM, Azad MD, Mohammadi AV, Teimori Z. Feasibility, reliability and validity of the Iranian version of the Diabetes Quality of Life Brief Clinical Inventory (IDQOL-BCI). Diabetes Res Clin Pract. 2012 May;96(2):237-47. doi: 10.1016/j.diabres.2011.12.030. Epub 2012 Feb 1.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2019P002349
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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