Crisaborole Ointment for Skin Toxicity Induced by Cetuximab

Study Overview
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Brief Summary
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This is a prospective, single-arm, phase II clinical trial that will enroll metastatic colorectal cancer patients with Cetuximab-Related Skin Toxicity, who will receive crisaborole ointment twice daily.

Detailed Description
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The efficacy of cetuximab has been demonstrated in treating metastatic colorectal cancer (mCRC). Skin toxicities, especially acneiform eruption, are the major side effects associated with cetuximab, which affect patients' quality of life and can lead to treatment discontinuation and cetuximab dose reduction. 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.

Official Title
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Efficacy and Safety of Crisaborole Ointment, a Phosphodiesterase 4 (PDE4) Inhibitor, for the Topical Treatment of Cetuximab-Related Skin Toxicity Among Metastatic Colorectal Cancer Patients：A Prospective, Single-arm, Phase II Clinical Trial

Conditions
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Metastatic Colorectal Cancer, Cetuximab, Skin Toxicity

Intervention / Treatment
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* Drug: Crisaborole Ointment
* Drug: Cetuximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed mCRC and undergoing Cetuximab treatment; ≥2 grade EGFR inhibitor-related acneiform eruption, evaluated by National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE）5.0; Age 18 years and older； ECOG performance status 0-2.； Bone marrow ,brain, heart, kidney and other organ function well;； Expected survival time more than 3 months; Exclusion Criteria: The presence of any active skin disease； Undergoing any current hormone therapy for any other disease; Prior allergic reaction or severe intolerance to crisaborole ointment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>crisaborole ointment | Drug: Crisaborole Ointment<br>* Crisaborole ointment to be applied twice daily.<br>Drug: Cetuximab<br>* Cetuximab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rate of EGFR inhibitor-related acneiform eruption | Grading of acneiform eruption would be assessed according to National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE) 5.0. Remission was defined as a reduction in acneiform eruption from grade 2 to grade 1 or grade 3 to grade 2 sustained for at least 2 weeks. | From date of randomization until the date of remission，assessed up to 8 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission time of EGFR inhibitor-related acneiform eruption | Grading of acneiform eruption would be assessed according to NCI-CTCAE 5.0. Remission was defined as a reduction in acneiform eruption from grade 2 to grade 1 or grade 3 to grade 2 sustained for at least 2 weeks | From date of randomization until the date of remission，assessed up to 8 weeks. | 
| Cetuximab treatment discontinuation rate | Rate of Cetuximab treatment discontinuation due to skin toxicity | 8 weeks from randomization. | 
| Cetuximab dose reduction rate | Rate of Cetuximab dose reduction due to skin toxicity | 8 weeks from randomization. | 
| Level of paronychia, xeroderma and pruritus | Grading of paronychia, xeroderma and pruritus would be assessed according to NCI-CTCAE 5.0. | 8 weeks from randomization. | 
| Quality of life (FACT-EGFRI-18) | Functional Assessment of Cancer Therapy （FACT）questionnaire to assess dermatologic symptoms associated with epidermal growth factor receptor inhibitors （FACT-EGFRI-18） | The 0,2,4,6,8,10,12 weeks from randomization. | 
| Quality of life（EORTC QLQ-C30) | Questionnaire of the European Organisation for Research and Treatment of Cancer quality of life (EORTC QLQ-C30) | The 0,2,4,6,8,10,12 weeks from randomization. |