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skin · 1 trial · 1 indication
Common Terminology Criteria for Adverse Events (CTCAE) V.4 will be used to evaluate the toxicity
| Arm | Type | Description |
|---|---|---|
| Mepitel Film | EXPERIMENTAL | Mepitel film will be placed on the patients' skin just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of the toxicities. In case of new skin toxicities appearance the patient will be retreated with Mepitel. |
| Excipial U hydrolotion, Flammazin skin cream | ACTIVE_COMPARATOR | Patients will be treated with aqueous (Excipial U hydrolotion) or antiseptic (Flammazine or Ialugen Plus) cream in case of skin erythema due to radiotherapy. In case of new skin toxicities appearance the patient will be retreated with standard of care treatment. |
| Name | Type | Description |
|---|---|---|
| Mepitel Film | DEVICE | Placement of Mepitel Film to prevent skin toxicity |
| skin cream | DRUG | cream to treat skin erythema due to radiotherapy |
Inclusion Criteria: * patients with breast cancer treated with conservative surgery who need radiotherapy treatment * capability and willness to participate to the study * informed consent form signature Exclusion Criteria: * contraindication to the correct placement of the Mepitel Film * previou...
Skin, also known as Mepitel Film, is an investigational small molecule being studied for the prevention and management of cutaneous toxicity due to post-surgery radiotherapy. It is intended for use in patients undergoing radiation therapy after surgery to help protect the skin from radiation-induced damage.
Skin is being developed by DarioHealth Corp. (NASDAQ: DRIO). The company is conducting clinical research on this product for the prevention and treatment of skin toxicity associated with post-surgery radiotherapy.
Skin is currently in Phase 3 clinical development. It has completed a Phase 3 trial, and the product remains investigational, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical evaluation.
Skin has been studied in one completed Phase 3 clinical trial, identified as NCT02741258. This trial, titled 'Mepitel Film Treatment for the Prevention and Cutaneous Toxicity Due to Radiotherapy,' enrolled 164 female participants aged 18 years and older in Switzerland.
Yes, skin is also known as Mepitel Film. The clinical trial NCT02741258 refers to the product as Mepitel Film, which is the name used in the study for the investigational treatment being evaluated for the prevention of cutaneous toxicity due to radiotherapy.