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

NCT06868771 | Recruiting

• 1 other identifier: SID04
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Xerosis Cutis

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• skin problems on quality of life (SKINDEX-16)

  3 months

• Visual Analogue Scale (VAS)

  3 months

Study Arms (2)

cases

OTHER

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.

control

OTHER

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.

Interventions

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

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

cases; control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 18 who have been receiving anti-EGFR therapy for more than three months,
• signature of the informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Irccs Fondazione Policlinico Gemelli

Roma, ROMA, 00168, Italy

RECRUITING

MeSH Terms

Interventions

Therapeutics; Niacinamide

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Ketty MD Peris

  IRCCS FONDAZIONE POLICLINICO GEMELLI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ketty MD Peris

CONTACT

0630154211; ketty.peris@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: March 11, 2025
• Study Start: July 29, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)