Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis.

NCT04692389 | Withdrawn

• 1 other identifier: Welcare 012020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiodermatitis; Oncology; Quality of Life; Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain quality and intensity

  8 weeks

• Skindex questionnaire - 16 for quality of life

  at the beginning, after 4 weeks and after 8 weeks

Study Arms (1)

Jalosome® Soothing gel

EXPERIMENTAL

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

Interventions

Jalosome soothing gel DEVICE

This study has not got other intervention

Also known as: No other intervention

Jalosome® Soothing gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Welcare Industries SpA: lead
• Oncology Institute of Southern Switzerland: collaborator

Study Sites (1)

Oncology Institute Of Southern Switzerland -radio oncology unit

Bellinzona, Canton Ticino, 6501, Switzerland

Location

MeSH Terms

Conditions

Radiodermatitis; Neoplasms; Pain

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: December 31, 2020
• Study Start: February 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: March 31, 2023
• Last Updated: February 8, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)