NCT04692389

Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis.

The Efficacy of the Medical Device Jalosome® Soothing Gel in the Healing of Grade of 2 or 3 Radiodermatitis, Pain Intensity Reduction, as Well as Improvement of QoL in Oncology Patients: a Pilot Study.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Welcare Industries SpA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Radiodermatitis
• Oncology
• Quality of Life
• Pain

Interventions

Type	Name	Description
DEVICE	Jalosome soothing gel	This study has not got other intervention

Timeline

• Start date: 2021-02-01
• Primary completion: 2023-02-01
• Completion: 2023-03-31
• First posted: 2020-12-31
• Last updated: 2022-02-08

Locations

1 site across 1 country: Switzerland