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

ConditionXerosis Cutis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSocieta Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients aged 18 who have been receiving anti-EGFR therapy for more than three months,

signature of the informed consent.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

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

Treatment groups

164 Participants
are divided into 2 treatment groups
Group A: casesOther 1 intervention
Group B: controlOther 1 intervention

Trial outcomes

Primary outcomes

1

Skin hydration

Evaluation of increased skin hydration by comparing specific epidermal parameters in the RCM at different times.

Time frame
3 months
2

decrease in surface desquamation

assess the decrease in superficial skin desquamation

Time frame
3 months
3

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

Time frame
3 months
4

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

Time frame
3 months

Secondary outcomes

1

skin problems on quality of life (SKINDEX-16)

incidence of skin problems on quality of life

Time frame
3 months
2

Visual Analogue Scale (VAS)

itch scale

Time frame
3 months

Other outcomes

Sponsors and contacts

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