Topical Cosmetic Products for Hand and Foot Syndrome

NCT ID: NCT06586073

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-31
• Study Completion Date: 2023-11-30

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.

Conditions

Hand Foot Skin Syndrome

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

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

cosmetic products

Intervention Type: OTHER

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.

Interventions

cosmetic products

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: collaborator

Dermophisiologique s.r.l

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ida Minchella

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

European Institute of Oncology (IEO)

Milan, Milan, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 29527024 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35867950 (View on PubMed)

Other Identifiers

R1633/22-IEO 1748

Identifier Type: -

Identifier Source: org_study_id