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

Atopic Dermatitis Clinical Trial

Official title:

An Open Label, Photo Documentation Study of Crisaborole Ointment 2% in Mild to Moderate Atopic Dermatitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04214197
• Other study ID #: 2019P002349
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 3, 2020
• Est. completion date: August 2021

Study information

• Verified date: February 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: August 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.

Locations

Country	Name	City	State
United States	MGH Clinical Unit for Research Trials in Skin (CURTIS)	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (16)

Castellsague J, Kuiper JG, Pottegård A, Anveden Berglind I, Dedman D, Gutierrez L, Calingaert B, van Herk-Sukel MP, Hallas J, Sundström 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. — View Citation

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. — View Citation

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. Review. — View Citation

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.

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. — View Citation

Gantner F, Götz 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Yosipovitch G, Reaney M, Mastey V, Eckert L, Abbé 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   MGH Dermatology