Topical Cosmetic Products for Hand and Foot Syndrome

Dermophisiologique s.r.l

Status: Completed

Conditions: Hand Foot Skin Syndrome

Treatments: Other: cosmetic products

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06586073

R1633/22-IEO 1748

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

53 participants in 1 patient group

Diagnosed cancer patients receiving different therapies with hand-foot syndrome skin side effects

Description:

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

Treatment:

Other: cosmetic products