Clinical Trials in Italy / NCT06868771
Recruiting
Not applicable
Study on the Effectiveness of an Emollient Cream Containing Pre and Postbiotic and Niacinamide 4% in the Treatment of Skin Xerosis and Itching in Oncological Patients Treated with Anti-EGFR
NCT06868771 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Xerosis Cutis
Investigational drug(s) / intervention(s)
topical treatment with the pre- and postbiotic study preparation and niacinamide 4% and one with the 10% urea-based preparation.
topical treatment with the pre- and postbiotic study preparation and niacinamide 4% and one with the 10% urea-based preparation.: Application of the topical preparation in both groups will be performed twice a day for a total duration of 3 months.
Study summary
Study on the Effectiveness of an Emollient Cream Containing Pre and Postbiotic and Niacinamide 4% in the Treatment of Skin Xerosis and Itching in Oncological Patients Treated With Anti-EGFR.
Eligibility
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.
Primary outcome measure(s)
- Skin hydration — 3 months
Evaluation of increased skin hydration by comparing specific epidermal parameters in the RCM at different times. - decrease in surface desquamation — 3 months
assess the decrease in superficial skin desquamation - clinical evaluation the decrease in the size of the skin grooves — 3 months
evaluate the decrease in the size of the skin grooves in the stratum corneum at different timepoints - decrease in cellular irregularities — 3 months
assess the decrease in cellular irregularities in the stratum corneum and the stratum spinous and inflammation in the superficial dermis at different time points - clinical evaluation the increase in the degree of brilliance of the intercheratinocyte space — 3 months
assess the increase in the degree of brilliance of the intercheratinocyte space in the spinous layer the different timepoints; - changes in the arrangement of collagen fibres in the dermis — 3 months
assess thickening and changes in the arrangement of collagen fibers in the dermis to the different timepoint
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Irccs Fondazione Policlinico Gemelli | Roma | ROMA | Recruiting |
More Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse trials in Italy
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06868771 on ClinicalTrials.gov ↗ ← All trials in Italy