Xerosis CutisPENSANTENCT06868771
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
A study testing topical treatment with the pre- and postbiotic study preparation and niacinamide 4% and one with the 10% urea-based preparation. in people with Xerosis Cutis, run by Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerosis Cutis
- What is being tested?
- topical treatment with the pre- and postbiotic study preparation and niacinamide 4% and one with the 10% urea-based preparation.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteItaly
- Study dates
- 29 Jul 2022to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 18 who have been receiving anti-EGFR therapy for more than three months,
- signature of the informed consent.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Irccs Fondazione Policlinico Gemelli
Roma, ROMA, 00168
Ketty MD Peris, 0630154211, ketty.peris@unicatt.it
About this study
Official title: Studio Sulla Efficacia Di Una Crema Emolliente Contenente Pre E Postbiotici E Niacinamide 4% Nel Trattamento Della Xerosi Cutanea E Del Prurito in Pazienti Oncologici in Trattamento Con Anti-EGFR
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.
Read the 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
- Being tested
- topical treatment with the pre- and postbiotic study preparation and niacinamide 4% and one with the 10% urea-based preparation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| cases | Other | topical treatment with the pre- and postbiotic and niacinamide 4% study preparation Receives: 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. Receives: Other: topical treatment with the pre- and postbiotic study preparation and niacinamide 4% and one with the 10% urea-based preparation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin hydration
Evaluation of increased skin hydration by comparing specific epidermal parameters in the RCM at different times.
Measured: 3 months
decrease in surface desquamation
assess the decrease in superficial skin desquamation
Measured: 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
Measured: 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
Measured: 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;
Measured: 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
Measured: 3 months
Secondary outcomes (2)
skin problems on quality of life (SKINDEX-16)
incidence of skin problems on quality of life
Measured: 3 months
Visual Analogue Scale (VAS)
itch scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start29 Jul 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Xerosis CutisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ketty MD Peris, Principal investigator, IRCCS FONDAZIONE POLICLINICO GEMELLI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868771
- Sponsor's protocol ID
- SID04
- Acronym
- PENSANTE
- Status last verified
- Mar 2025
- First submitted
- 25 Jul 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studio Sulla Efficacia Di Una Crema Emolliente Contenente Pre E Postbiotici E Niacinamide 4% Nel Trattamento Della Xerosi Cutanea E Del Prurito in Pazienti Oncologici in Trattamento Con Anti-EGFR
- ClinicalTrials.gov ID
- NCT06868771
- Acronym / sponsor ID
- PENSANTE / SID04
- Conditions
- Xerosis Cutis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente TrasmesseUniversity, hospital or other
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | Other | Other: topical treatment with the pre- and postbiotic study preparation and niacinamide 4% and one with the 10% urea-based preparation.topical treatment with the pre- and postbiotic and niacinamide 4% study preparation |
| control | Other | Other: topical treatment with the pre- and postbiotic study preparation and niacinamide 4% and one with the 10% urea-based preparation.prepared from 10% urea. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged 18 who have been receiving anti-EGFR therapy for more than three months,
- signature of the informed consent.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | cases, control |
Primary outcome
Skin hydration
Time frame: 3 months
Evaluation of increased skin hydration by comparing specific epidermal parameters in the RCM at different times.
decrease in surface desquamation
Time frame: 3 months
assess the decrease in superficial skin desquamation
clinical evaluation the decrease in the size of the skin grooves
Time frame: 3 months
evaluate the decrease in the size of the skin grooves in the stratum corneum at different timepoints
decrease in cellular irregularities
Time frame: 3 months
assess the decrease in cellular irregularities in the stratum corneum and the stratum spinous and inflammation in the superficial dermis at different time points
clinical evaluation the increase in the degree of brilliance of the intercheratinocyte space
Time frame: 3 months
assess the increase in the degree of brilliance of the intercheratinocyte space in the spinous layer the different timepoints;
changes in the arrangement of collagen fibres in the dermis
Time frame: 3 months
assess thickening and changes in the arrangement of collagen fibers in the dermis to the different timepoint
2 secondary outcomes
skin problems on quality of life (SKINDEX-16)
Time frame: 3 months
Visual Analogue Scale (VAS)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Xerosis Cutis
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Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ketty MD Peris principal investigator
IRCCS FONDAZIONE POLICLINICO GEMELLI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing topical treatment with the pre- and postbiotic study preparation and niacinamide 4% and one with the 10% urea-based preparation. in people with Xerosis Cutis, run by Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ketty MD Peris (0630154211, ketty.peris@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin hydration (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.