NCT03255980

Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Xonrid®

Monocenter, Open Label Clinical Investigation on the Treatment With Xonrid®, a Medical Device for the Prevention and Treatment of Radiotherapy-induced Dermatitis, in Breast and Head & Neck Cancer Patients Receiving Curative Treatment.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Helsinn Healthcare SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the performance of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head \& neck cancer patients.

Detailed description

The aim of this clinical investigation is to evaluate if the use of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head \& neck cancer patients can be a valid support, when compared to the Standard of Care as defined by MASCC (Multinational Association for Supportive Care in Cancer) guidelines.

Conditions

• Radiodermatitis
• Quality of Life

Interventions

Type	Name	Description
DEVICE	Xonrid® gel	Water based gel for the management of toxicity skin symptoms induced by Radiotherapy
OTHER	Standard of Care	Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines

Timeline

• Start date: 2017-06-15
• Primary completion: 2019-02-20
• Completion: 2020-01-22
• First posted: 2017-08-21
• Last updated: 2020-12-16
• Results posted: 2020-12-16

Locations

1 site across 1 country: Italy