RecruitingNot Applicable

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

Italy164 participantsStarted 2022-07-29

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Skin hydration

Timeframe: 3 months

decrease in surface desquamation

Timeframe: 3 months

clinical evaluation the decrease in the size of the skin grooves

Timeframe: 3 months

decrease in cellular irregularities

Timeframe: 3 months

clinical evaluation the increase in the degree of brilliance of the intercheratinocyte space

Timeframe: 3 months

changes in the arrangement of collagen fibres in the dermis

Timeframe: 3 months

Trial details

NCT IDNCT06868771

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-30

Contact for this trial

Ketty MD Peris

0630154211 ketty.peris@unicatt.it

View on ClinicalTrials.gov More Xerosis Cutis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Skin hydration

Timeframe: 3 months

decrease in surface desquamation

Timeframe: 3 months

clinical evaluation the decrease in the size of the skin grooves

Timeframe: 3 months

decrease in cellular irregularities

Timeframe: 3 months

clinical evaluation the increase in the degree of brilliance of the intercheratinocyte space

Timeframe: 3 months

changes in the arrangement of collagen fibres in the dermis

Timeframe: 3 months