Clinical trial NCT06868771: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Xerosis Cutis
Lead sponsor: Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Skin hydration
timeFrame: 3 months
measure: decrease in surface desquamation
timeFrame: 3 months
measure: clinical evaluation the decrease in the size of the skin grooves
timeFrame: 3 months
measure: decrease in cellular irregularities
timeFrame: 3 months
measure: clinical evaluation the increase in the degree of brilliance of the intercheratinocyte space
timeFrame: 3 months
measure: changes in the arrangement of collagen fibres in the dermis
timeFrame: 3 months
Secondary outcomes:
measure: skin problems on quality of life (SKINDEX-16)
timeFrame: 3 months
measure: Visual Analogue Scale (VAS)
timeFrame: 3 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Irccs Fondazione Policlinico Gemelli
Study officials:
affiliation: IRCCS FONDAZIONE POLICLINICO GEMELLI
name: Ketty MD Peris
role: PRINCIPAL_INVESTIGATOR
References: