Clinical trial NCT06586073: Topical Cosmetic Products for Hand and Foot Syndrome
Official title: Evaluation of the Efficacy of Topical Cosmetic Products in Patients with Hand and Foot Syndrome (HFS) Undergoing Oncological Treatments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hand Foot Skin Syndrome
Keywords: Hand-foot syndrome
skin toxicity
cancer treatments
quality of life
cosmetic products
Lead sponsor: Dermophisiologique s.r.l
Sponsor class: INDUSTRY
Collaborators: name: European Institute of Oncology
First posted: 2024-09-19
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were diagnosed cancer patients recruited from the oncology departments at the European Institute of Oncology, Milan, Italy.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from Baseline in the mean skin hydration index at 45 days
timeFrame: Baseline and 45 days
Secondary outcomes:
measure: Change from Baseline in the mean skin redness index at 45 days
timeFrame: Baseline and 45 days
measure: Change from Baseline in the mean overall Skindex-16 score at 45 days
timeFrame: Baseline and 45 days
measure: Assessment from baseline of compliance with the study protocol at 45 days
timeFrame: Baseline and 45 days
measure: 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).
timeFrame: Baseline and 45 days
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology (IEO)
Study officials:
affiliation: European Institute of Oncology
name: Ida Minchella
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Saadet 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.