An interventional study of topical treatment with the pre- and postbiotic study preparation and niacinamide 4% and one with the 10% urea-based preparation. in Xerosis Cutis, sponsored by Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse · Not applicable, Interventional, and Treatment
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.
Epidermal growth factor receptor inhibitors (EGFRi) are drugs approved as treatment options in several solid tumors, such as advanced colon, head-neck, breast and lung cancers, because overexpression or mutation of EGFR is implicated in the pathogenesis of these types of cancer. EGFR, in addition to being expressed by neoplastic cells, is also present constitutively on basal keratinocytes, and its inhibition can determine in these cells apoptotic effects, cell growth inhibition, alteration of physiological cell migration and inflammatory processes through the release of pro-inflammatory cytokines, recruitment of leukocytes and the release of pro-apoptotic molecules.
Among the possible adverse skin events (cae), the papulo-pustular rash is the most frequent in the course of therapy with EGFRi (45-90%). In addition to the papulopustulous rash, xerosis and itching are the main dermatological AE associated with EGFRi therapy, with a significant negative impact on the quality of life (qol) of cancer patients.
The reduction of itching and subsequent scratching can therefore be effective in preventing the exacerbation of skin lesions and improving qol in cancer patients, especially in those who experience intense skin xerosis. Emollients containing urea and ceramides have proved useful in skin hydration in case of cutaneous xerosis and in attenuating the associated itching. However, there are few articles in the literature that compare the moisturizing and antipruritic effects of the various basic components of emollients, especially in patients undergoing oncological treatment with EGFRi.
The goals are to examine the effectiveness of an emollient cream containing the prebiotic α-glucan oligosaccharide, the postbiotic Lactobacillus ferment pure (obtained by patented extraction method BPTech) and niacinamide 4%, in the treatment of xerosis, and to test the effectiveness and superiority of this topical preparation in skin hydration and in soothing pruritic symptoms compared to a 10% urea cream commonly used in clinical practice in patients with skin xerosis.
Exclusion Criteria:
topical treatment with the pre- and postbiotic and niacinamide 4% study preparation
Other: topical treatment with the pre- and postbiotic study preparation and niacinamide 4% and one with the 10% urea-based preparation.
prepared from 10% urea.
Other: 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.
Skin hydration
Evaluation of increased skin hydration by comparing specific epidermal parameters in the RCM at different times.
Time frame: 3 months
decrease in surface desquamation
assess the decrease in superficial skin desquamation
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
clinical evaluation the increase in the degree of brilliance of the intercheratinocyte space
assess the increase in the degree of brilliance of the intercheratinocyte space in the spinous layer the different timepoints;
Time frame: 3 months
changes in the arrangement of collagen fibres in the dermis
assess thickening and changes in the arrangement of collagen fibers in the dermis to the different timepoint
Time frame: 3 months
skin problems on quality of life (SKINDEX-16)
incidence of skin problems on quality of life
Time frame: 3 months
Visual Analogue Scale (VAS)
itch scale
Time frame: 3 months
Plan to share: No
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Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse