Crisaborole ointment for skin issues caused by cancer treatment
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
This study is testing if crisaborole ointment can help relieve skin problems caused by cancer treatment in people with metastatic colorectal cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | Cetuximab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06118047 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial investigates the effectiveness and safety of crisaborole ointment in patients with metastatic colorectal cancer experiencing skin toxicity due to cetuximab treatment. The study will enroll 33 participants who will apply the ointment twice daily for 12 weeks. The primary focus is on alleviating acneiform eruptions, a common side effect that can significantly impact patients' quality of life and treatment adherence.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with metastatic colorectal cancer undergoing cetuximab treatment and experiencing moderate to severe skin toxicity.
Not a fit: Patients with active skin diseases or those who have had severe allergic reactions to crisaborole ointment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve the quality of life for patients suffering from skin toxicity related to cetuximab.
How similar studies have performed: While this approach is novel in the context of cetuximab-related skin toxicity, similar interventions for managing skin side effects in cancer treatments have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosed mCRC and undergoing Cetuximab treatment; 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: 1. The presence of any active skin disease； 2. Undergoing any current hormone therapy for any other disease; 3. Prior allergic reaction or severe intolerance to crisaborole ointment
Where this trial is running
Guangzhou, Guangdong
- WeiWei Xiao — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Weiwei Xiao — Sun Yat-sen University
- Study coordinator: Weiwei Xiao
- Email: xiaoww@sysucc.org.cn
- Phone: +8613710390520
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.