Xerosis Cutis
Conditions
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.
Interventions
OTHERtopical 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.
Sponsors
Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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; |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) | 3 months | itch scale |
| skin problems on quality of life (SKINDEX-16) | 3 months | incidence of skin problems on quality of life |
Countries
Italy
Contacts
Primary ContactKetty MD Peris
Outcome results
None listed