Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586073
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Topical Cosmetic Products for Hand and Foot Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Efficacy of Topical Cosmetic Products in Patients with Hand and Foot Syndrome HFS Undergoing Oncological Treatments
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor xerosis andor mild to moderate nail damage to ensure an improvement of the skin condition during therapy
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 andor xerosis andor mild to moderate nail damage to ensure an improvement of the skin condition during therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None