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Clinical Trial Summary

Testing the efficacy of the Jalosome® Soothing gel in 2 or 3 grade radiodermatitis healing in oncological patients. The investigators would like to know also the efficacy of the device on quality of life and pain.


Clinical Trial Description

The overall objective of the study is to evaluate the efficacy of the class IIA medical device Jalosome® soothing gel in the healing of grade 2 or 3 radiodermatitis, in oncology patients undergoing radiotherapy treatment, during a 8-week observation period. The secondary endpoints are radiodermatitis pain control and quality of life. The investigators would like to involve 30 oncology patients. All oncology diagnosis will be included in this pilot study. The study will adopt a quasi-experimental design with one arm. The results will be used to determine the sample size for a clinical trial in which the class IIA medical device Jalosome® soothing gel will be compared to usual care. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04692389
Study type Interventional
Source Welcare Industries SpA
Contact
Status Withdrawn
Phase N/A
Start date February 1, 2021
Completion date March 31, 2023

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