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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crisaborole | Other | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crisaborole 2% Top Oint | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to success (in days) on ISGA | 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 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH Clinical Unit for Research Trials in Skin (CURTIS) | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26377142 | Background | 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. | |
| 29569785 | Background | 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 << OBJECTIFS PEAU >> study. J Eur Acad Dermatol Venereol. 2018 Nov;32(11):1967-1971. doi: 10.1111/jdv.14959. Epub 2018 Jul 16. |
| Label | URL |
|---|---|
| MGH Dermatology | View source |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C543085 | crisaborole |
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| 22808063 | Background | 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. |
| 28577797 | Background | 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. |
| 23703374 | Background | 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. |
| 29559812 | Background | 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. |
| 9559883 | Background | 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. |
| 8389777 | Background | 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. |
| 26777394 | Background | 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. |
| 27417017 | Background | 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. |
| 26461821 | Background | 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. |
| Background | 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. |
| 30729499 | Background | 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. |
| 8033378 | Background | 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. |
| 26686685 | Background | 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. |
| 22306060 | Background | 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. |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |