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 (PENSANTE)

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 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.

Study Overview

• Status: Recruiting
• Conditions: Xerosis Cutis
• Intervention / Treatment: Other: topical treatment with the pre- and postbiotic study preparation and niacinamide 4% and one with the 10% urea-based preparation.

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.

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ketty MD Peris; Phone Number: 0630154211; Email: ketty.peris@unicatt.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • IRCCS Fondazione Policlinico Gemelli
    • Contact: Ketty MD Peris; Phone Number: 0630154211; Email: ketty.peris@unicatt.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: cases; 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.; Application of the topical preparation in both groups will be performed twice a day for a total duration of 3 months.
Other: control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin hydration	Evaluation of increased skin hydration by comparing specific epidermal parameters in the RCM at different times.	3 months
decrease in surface desquamation	assess the decrease in superficial skin desquamation	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	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	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;	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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
skin problems on quality of life (SKINDEX-16)	incidence of skin problems on quality of life	3 months
Visual Analogue Scale (VAS)	itch scale	3 months

Collaborators and Investigators

• Sponsor: Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse
• Investigators: Principal Investigator: Ketty MD Peris, IRCCS Fondazione Policlinico Gemelli

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Micronutrients; Vitamin B Complex; Vitamins; Vasodilator Agents; Hypolipidemic Agents; Lipid Regulating Agents; Niacin; Niacinamide; Nicotinic Acids
• Other Study ID Numbers: SID04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No