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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: topical treatment with the pre- and postbiotic study preparation and niacinamide 4% and one with the 10% urea-based preparation..
- Who it may be relevant to
- Registry conditions: Xerosis Cutis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Skin hydration [Time frame: 3 months]
- decrease in surface desquamation [Time frame: 3 months]
- clinical evaluation the decrease in the size of the skin grooves [Time frame: 3 months]
- decrease in cellular irregularities [Time frame: 3 months]
- clinical evaluation the increase in the degree of brilliance of the intercheratinocyte space [Time frame: 3 months]
- changes in the arrangement of collagen fibres in the dermis [Time frame: 3 months]
Secondary outcome measures (2)
- skin problems on quality of life (SKINDEX-16) [Time frame: 3 months]
- Visual Analogue Scale (VAS) [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- patients aged 18 who have been receiving anti-EGFR therapy for more than three months,
- signature of the informed consent.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Irccs Fondazione Policlinico Gemelli — Roma
Identifiers
NCT: NCT06868771 · SID04