Hand Foot Skin SyndromeNCT06586073
Topical Cosmetic Products for Hand and Foot Syndrome
An observational study of Hand Foot Skin Syndrome, run by Dermophisiologique s.r.l at 1 site in Italy.
Trial summary
The aim of the study is to evaluate the efficacy of a dermocosmetic protocol in reducing the main cutaneous side effects that occur in palmar-plantar erythrodysesthesia syndrome in subjects with a tumor diagnosis, undergoing chemotherapy and targeted treatments such as target therapy and radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Foot Skin Syndrome
- What is being tested?
- cosmetic products
- How many people
- 53 participants
- Where
- 1 siteItaly
- Study dates
- 31 Aug 2022to 30 Nov 2023
- How long will I take part?
- 45 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Participants were diagnosed cancer patients recruited from the oncology departments at the European Institute of Oncology, Milan, Italy.
Who may be able to join
- Cancer diagnosis undergoing oncological therapy with chemotherapeutic agents, targeted therapy, immunotherapy hormonal treatments
- Patients with grade 1 of Hand-foot syndrome (HFS) Male and female patients 18 age or more
- Conditions favoring the correct execution of the proposed program
- Signature of informed consent, privacy and the form for the use of the data
Who cannot join
- Pregnancy or breastfeeding in progress
- Other skin toxixities different from HFS
- Patients with HFS adverse skin symptoms higher than grade 1
- Psychic or other disorderes
- Patients with preexisting skin disorders thet could interfere with thw study results (like dermatitis, prosriais)
- Known hypersensitivity or allergy to one of the components of the products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Topical Cosmetic Products in Patients with Hand and Foot Syndrome (HFS) Undergoing Oncological Treatments
The aim of the study is to evaluate the efficacy of a dermocosmetic protocol in reducing the main cutaneous side effects that occur in palmar-plantar erythrodysesthesia syndrome in subjects with a tumor diagnosis, undergoing chemotherapy and targeted treatments such as target therapy and radiotherapy.
Read the detailed description
Cancer patients undergoing active oncological treatment (chemotherapy, biological therapies, radiotherapy) experience multiple side effects, including skin toxicity, which negatively affects their quality of life, increasing the risk of interrupting cancer therapy. Symptomatic therapy is often neglected and prescribed late in the course of the disease. Many patients undergoing anti-cancer therapies experience adverse skin reactions such as dry skin, rashes, redness, and itching. Dry skin, erythema, and nail lesions are particularly common for those undergoing chemotherapy and targeted treatments such as target therapy and radiotherapy.
Cleansing must be done by affinity, that is, with an emulsification mechanism and not solubilization, through the use of "sebum-like" fatty substances to remove only the excess lipids on the skin surface and the dirt attached to them. This eudermic cleansing without the use of surfactants does not solubilize the epidermal lipids that are fundamental in the structure of the hydrolipidic film, maintaining the right protection and hydration of the skin.
Therefore, the main objective of the following study is to evaluate the efficacy of 4 topical cosmetic products specifically formulated for patients undergoing oncological therapy in the management of palmar-plantar erythrodysesthesia syndrome, a skin toxicity typical of oncological treatments, which causes skin alterations such as erythema and/or xerosis and/or mild to moderate nail damage, to ensure an improvement of the skin condition during therapy.
- Conditions
- Hand Foot Skin Syndrome
- Being tested
- cosmetic products
- Keywords
- Hand-foot syndrome, skin toxicity, cancer treatments, quality of life, cosmetic products
- Medical subject headings
- Hand-Foot Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cosmetic productsOther
All patients enrolled were prescribed four cosmetic products (Ontherapy® by Dermophisiologique) for skin treatment: a cleansing cream, a soothing and nourishing cream, an anti-desquamation cream with urea 5%, and an emollient mixture. Patients were instructed to use each product at home for 45 days, following a specific protocol: in the morning, apply the affinity cleansing cream during skin cleansing, followed by the anti-desquamation cream, while in the evening, apply affinity cleansing cream followed by the application of the emollient mixture and then the soothing and nourishing cream.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed cancer patients receiving different therapies with hand-foot syndrome skin side effects | Participants were diagnosed cancer patients receiving chemotherapy and targeted or hormonal treatments. Recruitment was performed by the medical oncologists based on the presence of Hand-foot syndrome (HFS) grade 1 symptoms. The severity of HFS was graded according to the The National Cancer Institute-Common Terminology Criteria for Adverse Events Criteria (NCI-CTCAE) version 5.0. All patients enrolled were provided with a kit of four cosmetic products formulated explicitly for cancer skincare Receives: Other: cosmetic products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the mean skin hydration index at 45 days
Changes from the baseline of skin hydration were assessed using a Corneometer® CM 825 probe that analyze water related changes in the skin's electrical capacitance. All measurements reported are the average of three assessments obtained on two skin areas: the right hand 's dorsum and the right foot's dorsum
Measured: Baseline and 45 days
Secondary outcomes (4)
Change from Baseline in the mean skin redness index at 45 days
Changes from the baseline of skin redness (erythema) were measured photometrically by a Mexameter ® MX 18 30 32 All measurements reported are the average of three assessments obtained on four skin areas: the palm of the right hand, fingertip of the right hand, sole of the right foot and fingertip of the right foot.
Measured: Baseline and 45 days
Change from Baseline in the mean overall Skindex-16 score at 45 days
The impact of skin manifestations on patient Quality of life (QoL) was evaluated using the Skindex 16, a 16 item self report questionnaire. It is composed of three subscales: perceived symptoms (items 1-5), emotions (items 6-11), and daily functions (items 12-16).Responses to each item were transformed into a linear scale of 100, varying from 0 (never bothered) to 100 (corresponding to 6, always bothered). Each raw score was then normalized for the statistical to 100 (corresponding to 6, always bothered). Each raw score was then normalized for the statistical analysis. The final score is the average of the patient\'s responses in each domain.
Measured: Baseline and 45 days
Assessment from baseline of compliance with the study protocol at 45 days
The compliance of patients with the product use protocol was assessed through a specific diary within 45 days, divided into morning and evening, containing two boxes to tick (YES for products applied or NO for products not applied). Additionally, there is a NOTES section where the patient can input the reason for not applying the product
Measured: Baseline and 45 days
Change in the degree of toxicity of hand-foot syndrome using the v5.0 scale of the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE).
The oncologist and dermatologist clinically evaluated HFS severity by comparing patient pictures taken standardized at baseline and at the end of the study (45 days) on four body areas: the back of the hand, the back of the foot, the palm, and the sole. The oncologist assessed the change in the degree of hand-foot syndrome toxicity using the National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 scale. The dermatologist used a three-point evaluation (improvement, stability, worsening) to assess the change in HFS-related skin symptoms (erythema, xerosis, and desquamation). Treatment benefit was evaluated according to the reduction of the NCI CTCAE grade and the improvement of skin symptoms.
Measured: Baseline and 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start31 Aug 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hand Foot Skin SyndromeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 53 participants (actual)
- Target duration
- 45 Days
Sponsor and investigators
- Lead sponsor
- Dermophisiologique s.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Institute of Oncology
- Responsible party
- Sponsor
- Investigators
- Ida Minchella, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586073
- Sponsor's protocol ID
- R1633/22-IEO 1748
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Biswal SG, Mehta RD. Cutaneous Adverse Reactions of Chemotherapy in Cancer Patients: A Clinicoepidemiological Study. Indian J Dermatol. 2018 Jan-Feb;63(1):41-46. doi: 10.4103/ijd.IJD_65_17.
PubMed 29527024Saadet ED, Tek I. Evaluation of chemotherapy-induced cutaneous side effects in cancer patients. Int J Dermatol. 2022 Dec;61(12):1519-1526. doi: 10.1111/ijd.16361. Epub 2022 Jul 22.
PubMed 35867950
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Topical Cosmetic Products in Patients with Hand and Foot Syndrome (HFS) Undergoing Oncological Treatments
- ClinicalTrials.gov ID
- NCT06586073
- Acronym / sponsor ID
- R1633/22-IEO 1748
- Conditions
- Hand Foot Skin Syndrome
- Keywords
- Hand-foot syndrome, skin toxicity, cancer treatments, quality of life, cosmetic products
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Dermophisiologique s.r.lIndustry (pharma, biotech, devices)
- Collaborators
- European Institute of Oncology
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 19 Sep 2024 (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.
The aim of the study is to evaluate the efficacy of a dermocosmetic protocol in reducing the main cutaneous side effects that occur in palmar-plantar erythrodysesthesia syndrome in subjects with a tumor diagnosis, undergoing chemotherapy and targeted treatments such as target therapy and radiotherapy.
Detailed description
Cancer patients undergoing active oncological treatment (chemotherapy, biological therapies, radiotherapy) experience multiple side effects, including skin toxicity, which negatively affects their quality of life, increasing the risk of interrupting cancer therapy. Symptomatic therapy is often neglected and prescribed late in the course of the disease. Many patients undergoing anti-cancer therapies experience adverse skin reactions such as dry skin, rashes, redness, and itching. Dry skin, erythema, and nail lesions are particularly common for those undergoing chemotherapy and targeted treatments such as target therapy and radiotherapy.
Cleansing must be done by affinity, that is, with an emulsification mechanism and not solubilization, through the use of "sebum-like" fatty substances to remove only the excess lipids on the skin surface and the dirt attached to them. This eudermic cleansing without the use of surfactants does not solubilize the epidermal lipids that are fundamental in the structure of the hydrolipidic film, maintaining the right protection and hydration of the skin.
Therefore, the main objective of the following study is to evaluate the efficacy of 4 topical cosmetic products specifically formulated for patients undergoing oncological therapy in the management of palmar-plantar erythrodysesthesia syndrome, a skin toxicity typical of oncological treatments, which causes skin alterations such as erythema and/or xerosis and/or mild to moderate nail damage, to ensure an improvement of the skin condition during therapy.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 45 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosed cancer patients receiving different therapies with hand-foot syndrome skin side effects | – | Other: cosmetic productsParticipants were diagnosed cancer patients receiving chemotherapy and targeted or hormonal treatments. Recruitment was performed by the medical oncologists based on the presence of Hand-foot syndrome (HFS) grade 1 symptoms. The severity of HFS was graded according to the The National Cancer Institute-Common Terminology Criteria for Adverse Events Criteria (NCI-CTCAE) version 5.0. All patients enrolled were provided with a kit of four cosmetic products formulated explicitly for cancer skincare |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants were diagnosed cancer patients recruited from the oncology departments at the European Institute of Oncology, Milan, Italy.
Key inclusion criteria (4 listed)
- Cancer diagnosis undergoing oncological therapy with chemotherapeutic agents, targeted therapy, immunotherapy hormonal treatments
- Patients with grade 1 of Hand-foot syndrome (HFS) Male and female patients 18 age or more
- Conditions favoring the correct execution of the proposed program
- Signature of informed consent, privacy and the form for the use of the data
Key exclusion criteria (6 listed)
- Pregnancy or breastfeeding in progress
- Other skin toxixities different from HFS
- Patients with HFS adverse skin symptoms higher than grade 1
- Psychic or other disorderes
- Patients with preexisting skin disorders thet could interfere with thw study results (like dermatitis, prosriais)
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 |
|---|---|---|
| cosmetic productsAll patients enrolled were prescribed four cosmetic products (Ontherapy® by Dermophisiologique) for skin treatment: a cleansing cream, a soothing and nourishing cream, an anti-desquamation cream with urea 5%, and an emollient mixture. Patients were instructed to use each product at home for 45 days, following a specific protocol: in the morning, apply the affinity cleansing cream during skin cleansing, followed by the anti-desquamation cream, while in the evening, apply affinity cleansing cream followed by the application of the emollient mixture and then the soothing and nourishing cream. | Other | Diagnosed cancer patients receiving different therapies with hand-foot syndrome skin side effects |
Primary outcome
Change from Baseline in the mean skin hydration index at 45 days
Time frame: Baseline and 45 days
Changes from the baseline of skin hydration were assessed using a Corneometer® CM 825 probe that analyze water related changes in the skin's electrical capacitance. All measurements reported are the average of three assessments obtained on two skin areas: the right hand 's dorsum and the right foot's dorsum
4 secondary outcomes
Change from Baseline in the mean skin redness index at 45 days
Time frame: Baseline and 45 days
Change from Baseline in the mean overall Skindex-16 score at 45 days
Time frame: Baseline and 45 days
Assessment from baseline of compliance with the study protocol at 45 days
Time frame: Baseline and 45 days
Change in the degree of toxicity of hand-foot syndrome using the v5.0 scale of the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE).
Time frame: Baseline and 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 29527024Biswal SG, Mehta RD. Cutaneous Adverse Reactions of Chemotherapy in Cancer Patients: A Clinicoepidemiological Study. Indian J Dermatol. 2018 Jan-Feb;63(1):41-46. doi: 10.4103/ijd.IJD_65_17.
- Background: PubMed 35867950Saadet ED, Tek I. Evaluation of chemotherapy-induced cutaneous side effects in cancer patients. Int J Dermatol. 2022 Dec;61(12):1519-1526. doi: 10.1111/ijd.16361. Epub 2022 Jul 22.
- Individual participant dataSharing planned: Undecided
Related trials for Hand Foot Skin Syndrome
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TAR-0520 Gel in Hand and Foot Syndrome
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Patients With Solid Tumors
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. This study is not recruiting at the moment.
Ida Minchella principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Foot Skin Syndrome, run by Dermophisiologique s.r.l 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the mean skin hydration index at 45 days (time frame: Baseline and 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06586073, which also lists 2 linked publications.
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 19 Sep 2024.