Status:
WITHDRAWN
Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis.
Lead Sponsor:
Welcare Industries SpA
Collaborating Sponsors:
Oncology Institute of Southern Switzerland
Conditions:
Radiodermatitis
Oncology
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
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 ra...
Eligibility Criteria
Inclusion
- Patients aged ≥18 years
- Patients with cancer\* undergoing radiotherapy treatment
- Patients with grade 2 or 3 radiotherapy lesions who are naive to radiodermatitis treatment or unresponsive to previous treatment
- Patients who have given written informed consent
- Patients expected to be followed at the centre for at least 8 weeks
- Patients with Karnofsky Performance Status(KPS) scale ≥ 40
Exclusion
- Patients with grade 1 and grade IV radiodermatitis
- Patients with known intolerance to the components in Jalosome® soothing gel
- Patients who have already received radiotherapy in the past on the irradiated area
- Patients with cognitive impairment that does not allow adequate compliance with the protocol
- Patients with brain metastases
- Pregnant or lactating patients
- Patients with KPS \< 40
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04692389
Start Date
February 1 2021
End Date
March 31 2023
Last Update
February 8 2022
Active Locations (1)
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1
Oncology Institute Of Southern Switzerland -radio oncology unit
Bellinzona, Canton Ticino, Switzerland, 6501