Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis.

• ClinicalTrials.gov Identifier: NCT04692389
• Recruitment Status: Withdrawn
• First Posted: December 31, 2020
• Last Update Posted: February 8, 2022
• Sponsor: Welcare Industries SpA
• Collaborator: Oncology Institute of Southern Switzerland
• Information provided by (Responsible Party): Welcare Industries SpA

Study Description

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 life and pain.

Condition or disease	Intervention/treatment	Phase
Radiodermatitis; Oncology; Quality of Life; Pain	Device: Jalosome soothing gel	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment

Intervention 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
• 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.
• Actual Study Start Date: February 1, 2021
• Estimated Primary Completion Date: February 1, 2023
• Estimated Study Completion Date: March 31, 2023

Arms and Interventions

Arm

Intervention/treatment

Experimental: Jalosome® Soothing gel; The medical device will be applied by the patient himself, after appropriate training carried out by the nurse, twice a day, in the quantity necessary to cover the lesion (0.2g of gel /16 cm2 of skin (one spray), repeated as many times as necessary to cover the entire lesion). The treatment will last 8 weeks. The medical device will be delivered in the quantity strictly necessary to carry out the therapies between visits, in order to monitor its use. Patients will be seen weekly by the nurse, in order to ensure the best continuity of care and promote adherence to the study. Patients will be asked to keep a weekly diary, in which they will report their level of pain, analgesic therapy and medication. Nurses will be available for telephone counselling, if necessary.

Device: Jalosome soothing gel; This study has not got other intervention; Other Name: No other intervention

Outcome Measures

Primary Outcome Measures :

1. Grade 2 or 3 radiodermatitis healing [ Time Frame: 8 weeks ]

   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.

Secondary Outcome Measures :

1. Pain quality and intensity [ Time Frame: 8 weeks ]
   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)).
2. Skindex questionnaire - 16 for quality of life [ Time Frame: at the beginning, after 4 weeks and after 8 weeks ]
   Quality of life will then be assessed as a second enpoint, using the Skindex questionnaire - 16

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Switzerland

Oncology Institute Of Southern Switzerland -radio oncology unit

Bellinzona, Canton Ticino, Switzerland, 6501

Sponsors and Collaborators

Welcare Industries SpA

Oncology Institute of Southern Switzerland

More Information

• Responsible Party: Welcare Industries SpA
• ClinicalTrials.gov Identifier: NCT04692389
• Other Study ID Numbers: Welcare 012020
• First Posted: December 31, 2020
• Last Update Posted: February 8, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Welcare Industries SpA:

radiodermatitis; oncology; quality of life; pain; wound healing

Additional relevant MeSH terms:

Neoplasms; Radiodermatitis; Dermatitis; Skin Diseases; Radiation Injuries; Wounds and Injuries