About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
patients aged 18 who have been receiving anti-EGFR therapy for more than three months,
signature of the informed consent.
Disqualifiers
Patients diagnosed with Grade II papulopustulous skin reaction according to the Common Terminology Criteria for Adverse Event (CTCAE) scale at the time of enrolment;
concomitant use of emollients and/or steroidal creams;
personal history of xerotic pathologies (e.g. lichen, ichthyosis) and/or itching of n.d.d.;
inability to provide informed consent or inability to complete the procedures required for enrollment in the study.
Trial design
Parallel
Treatments tested in this trial
topical treatment with the pre- and postbiotic study preparation and niacinamide 4% and one with the 10% urea-based preparation.
Other interventionApplication of the topical preparation in both groups will be performed twice a day for a total duration of 3 months.
Treatment groups
Trial outcomes
Primary outcomes
Skin hydration
Evaluation of increased skin hydration by comparing specific epidermal parameters in the RCM at different times.
decrease in surface desquamation
assess the decrease in superficial skin desquamation
clinical evaluation the decrease in the size of the skin grooves
evaluate the decrease in the size of the skin grooves in the stratum corneum at different timepoints
decrease in cellular irregularities
assess the decrease in cellular irregularities in the stratum corneum and the stratum spinous and inflammation in the superficial dermis at different time points
Secondary outcomes
skin problems on quality of life (SKINDEX-16)
incidence of skin problems on quality of life
Visual Analogue Scale (VAS)
itch scale
Sponsors and contacts
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