Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis.

Pain Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04692389
• Other study ID #: Welcare 012020
• Status: Withdrawn
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: January 2022
• Source: Welcare Industries SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Neoplasms
• Oncology
• Pain
• Quality of Life
• Radiodermatitis

Intervention

Device:
• Jalosome soothing gel
This study has not got other intervention

Locations

Country	Name	City	State
Switzerland	Oncology Institute Of Southern Switzerland -radio oncology unit	Bellinzona	Canton Ticino

Sponsors (2)

Lead Sponsor	Collaborator
Welcare Industries SpA	Oncology Institute of Southern Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade 2 or 3 radiodermatitis healing	The primary endpoint is the number of grade 2 or 3 radiodermatitis healed by the application of Jalosome® soothing gel during the observation period, out of the total number of patients treated. This endpoint will be assessed by photographic documentation of lesion improvement and healing and with the aid of the RGOT scale (which should regress from grade 2 or 3 to grade 0 or 1).; The time to regression of the lesion will also be monitored on this same endpoint in order to establish the rate of efficacy of the product against grade 2 and 3 lesions.	8 weeks
Secondary	Pain quality and intensity	The first secondary endpoint will be the intensity and quality of pain, measured respectively by the NRS scale and by questions on the type of pain perceived (twinge, burning, pins, allodynia (i.e. a painful impulse following a harmless stimulus), cramp-like, piercing (stab-like)).	8 weeks
Secondary	Skindex questionnaire - 16 for quality of life	Quality of life will then be assessed as a second enpoint, using the Skindex questionnaire - 16	at the beginning, after 4 weeks and after 8 weeks