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

NCT ID: NCT06868771

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-29
• Study Completion Date: 2025-04-30

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.

Conditions

Xerosis Cutis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

cases

topical treatment with the pre- and postbiotic and niacinamide 4% study preparation

Group Type: OTHER

topical treatment with the pre- and postbiotic study preparation and niacinamide 4% and one with the 10% urea-based preparation.

Intervention Type: OTHER

Application of the topical preparation in both groups will be performed twice a day for a total duration of 3 months.

control

prepared from 10% urea.

Group Type: OTHER

topical treatment with the pre- and postbiotic study preparation and niacinamide 4% and one with the 10% urea-based preparation.

Intervention Type: OTHER

Application of the topical preparation in both groups will be performed twice a day for a total duration of 3 months.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ketty MD Peris

Role: PRINCIPAL_INVESTIGATOR

IRCCS FONDAZIONE POLICLINICO GEMELLI

Locations

Irccs Fondazione Policlinico Gemelli

Roma, ROMA, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Ketty MD Peris

Role: CONTACT

ketty.peris@unicatt.it

0630154211

Facility Contacts

Ketty MD Peris

Role: primary

ketty.peris@unicatt.it

0630154211

Other Identifiers

SID04

Identifier Type: -

Identifier Source: org_study_id