Crisaborole Ointment for Skin Toxicity Induced by Cetuximab
NCT ID: NCT06118047
Last Updated: 2023-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
33 participants
INTERVENTIONAL
2023-08-01
2025-12-31
Brief Summary
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Detailed Description
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This prospective, single-arm, phase II clinical trial aims to explore the efficacy and safety of crisaborole ointment in Cetuximab-Related Skin Toxicity. A total of 33 mCRC patients with acneiform eruption will be enrolled. All of the participants will receive crisaborole ointment twice daily. The total follow-up time is 12 weeks.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention group
crisaborole ointment
Crisaborole Ointment
Crisaborole ointment to be applied twice daily.
Cetuximab
Cetuximab
Interventions
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Crisaborole Ointment
Crisaborole ointment to be applied twice daily.
Cetuximab
Cetuximab
Eligibility Criteria
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Inclusion Criteria
2. ≥2 grade EGFR inhibitor-related acneiform eruption, evaluated by National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE）5.0;
3. Age 18 years and older；
4. ECOG performance status 0-2.；
5. Bone marrow ,brain, heart, kidney and other organ function well;；
6. Expected survival time more than 3 months;
Exclusion Criteria
2. Undergoing any current hormone therapy for any other disease;
3. Prior allergic reaction or severe intolerance to crisaborole ointment
18 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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WeiWei Xiao
Chief physician
Principal Investigators
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Weiwei Xiao
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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WeiWei Xiao
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Kim YS, Ji JH, Oh SY, Lee S, Huh SJ, Lee JH, Song KH, Son CH, Roh MS, Lee GW, Lee J, Kim ST, Kim CK, Jang JS, Hwang IG, Ahn HK, Park LC, Oh SY, Kim SG, Lee SC, Lim DH, Lee SI, Kang JH. A Randomized Controlled Trial of Epidermal Growth Factor Ointment for Treating Epidermal Growth Factor Receptor Inhibitor-Induced Skin Toxicities. Oncologist. 2020 Jan;25(1):e186-e193. doi: 10.1634/theoncologist.2019-0221. Epub 2019 Sep 6.
Klufa J, Bauer T, Hanson B, Herbold C, Starkl P, Lichtenberger B, Srutkova D, Schulz D, Vujic I, Mohr T, Rappersberger K, Bodenmiller B, Kozakova H, Knapp S, Loy A, Sibilia M. Hair eruption initiates and commensal skin microbiota aggravate adverse events of anti-EGFR therapy. Sci Transl Med. 2019 Dec 11;11(522):eaax2693. doi: 10.1126/scitranslmed.aax2693.
Hofheinz RD, Lorenzen S, Trojan J, Ocvirk J, Ettrich TJ, Al-Batran SE, Schulz H, Homann N, Feustel HP, Schatz M, Kripp M, Schulte N, Tetyusheva M, Heeger S, Vlassak S, Merx K. EVITA-a double-blind, vehicle-controlled, randomized phase II trial of vitamin K1 cream as prophylaxis for cetuximab-induced skin toxicity. Ann Oncol. 2018 Apr 1;29(4):1010-1015. doi: 10.1093/annonc/mdy015.
Pinto C, Barone CA, Girolomoni G, Russi EG, Merlano MC, Ferrari D, Maiello E; American Society of Clinical Oncology; European Society of Medical Oncology. Management of skin toxicity associated with cetuximab treatment in combination with chemotherapy or radiotherapy. Oncologist. 2011;16(2):228-38. doi: 10.1634/theoncologist.2010-0298. Epub 2011 Jan 27.
Pinto C, Barone CA, Girolomoni G, Russi EG, Merlano MC, Ferrari D, Maiello E. Management of Skin Reactions During Cetuximab Treatment in Association With Chemotherapy or Radiotherapy: Update of the Italian Expert Recommendations. Am J Clin Oncol. 2016 Aug;39(4):407-15. doi: 10.1097/COC.0000000000000291.
Other Identifiers
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B2022-648
Identifier Type: -
Identifier Source: org_study_id
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