Topical Cosmetic Products for Hand and Foot Syndrome

NCT06586073 | Completed DMC

• 1 other identifier: R1633/22-IEO 1748
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Foot Skin Syndrome

Keywords

Hand-foot syndrome; skin toxicity; cancer treatments; quality of life; cosmetic products

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and 45 days

Secondary Outcomes (4)

• Change from Baseline in the mean skin redness index at 45 days

  Baseline and 45 days

• Change from Baseline in the mean overall Skindex-16 score at 45 days

  Baseline and 45 days

• Assessment from baseline of compliance with the study protocol at 45 days

  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).

  Baseline and 45 days

Study Arms (1)

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

Other: cosmetic products

Interventions

cosmetic products 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dermophisiologique s.r.l: lead
• European Institute of Oncology: collaborator

Study Sites (1)

European Institute of Oncology (IEO)

Milan, Milan, 20141, Italy

Location

Related Publications (2)

• 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.

  PMID: 29527024 BACKGROUND

• 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.

  PMID: 35867950 BACKGROUND

MeSH Terms

Conditions

Hand-Foot Syndrome

Interventions

Cosmetics

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses; Household Products; Technology, Industry, and Agriculture

Study Officials

• Ida Minchella

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 45 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 19, 2024
• Study Start: August 31, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-08

Locations

IT (1)