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Completed

NCT Number: NCT06586073

Topical Cosmetic Products for Hand and Foot Syndrome

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

European Institute of Oncology (IEO)

Milan, 20141, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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

  4. 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

    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.

Sponsors and collaborators

Lead sponsor

Dermophisiologique s.r.l

Industry

Collaborators

  • European Institute of Oncology

Registry information

Official study title

Evaluation of the Efficacy of Topical Cosmetic Products in Patients with Hand and Foot Syndrome (HFS) Undergoing Oncological Treatments

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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