Effect of a special cream on dry skin and itching in cancer patients receiving anti-EGFR treatment
Studio Sulla Efficacia Di Una Crema Emolliente Contenente Pre E Postbiotici E Niacinamide 4% Nel Trattamento Della Xerosi Cutanea E Del Prurito in Pazienti Oncologici in Trattamento Con Anti-EGFR
This study is testing a special cream to see if it can help cancer patients on anti-EGFR treatment with dry skin and itching.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse Academic / other |
| Locations | 1 site (Roma, ROMA) |
| Trial ID | NCT06868771 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a topical emollient cream containing pre and postbiotics along with 4% niacinamide in treating skin xerosis and itching in patients undergoing anti-EGFR therapy for cancer. The research focuses on addressing common dermatological side effects associated with EGFR inhibitors, which can significantly impact the quality of life of patients. Participants will be treated with either the study cream or a 10% urea-based preparation to compare their effects on skin hydration and itching relief. The study aims to provide a better management strategy for skin-related adverse events in oncological patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been receiving anti-EGFR therapy for more than three months.
Not a fit: Patients with severe skin reactions or those with a history of certain skin conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve skin hydration and reduce itching, enhancing the quality of life for cancer patients undergoing anti-EGFR therapy.
How similar studies have performed: While there are few studies directly comparing similar treatments, existing literature suggests that emollients can be beneficial for skin hydration in xerosis, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. patients aged 18 who have been receiving anti-EGFR therapy for more than three months, 2. signature of the informed consent. Exclusion Criteria: 1. Patients diagnosed with Grade II papulopustulous skin reaction according to the Common Terminology Criteria for Adverse Event (CTCAE) scale at the time of enrolment; 2. concomitant use of emollients and/or steroidal creams; 3. personal history of xerotic pathologies (e.g. lichen, ichthyosis) and/or itching of n.d.d.; 4. inability to provide informed consent or inability to complete the procedures required for enrollment in the study.
Where this trial is running
Roma, ROMA
- Irccs Fondazione Policlinico Gemelli — Roma, Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Ketty MD Peris — Irccs Fondazione Policlinico Gemelli
- Study coordinator: Ketty MD Peris
- Email: ketty.peris@unicatt.it
- Phone: 0630154211
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.