Evaluation of the Efficacy of Topical Cosmetic Products in Patients with Hand and Foot Syndrome (HFS) Undergoing Oncological Treatments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Change from Baseline in the mean skin hydration index at 45 days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from Baseline in the mean skin hydration index at 45 days
时间窗: 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
次要结局
- 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)