Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis.
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Oncology
- Pain
- Quality of Life
- Radiodermatitis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: The investigators would like to involve 30 oncology patients with 2 or 3 grade radiodermatitis (based on RTOG score). All oncology diagnosis will be included.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 radiodermatiti...
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.
Tracking Information
- NCT #
- NCT04692389
- Collaborators
- Oncology Institute of Southern Switzerland
- Investigators
- Not Provided
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