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 range18 Years

SexALL

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

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 range18 Years

SexALL

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