Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis.
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|ClinicalTrials.gov Identifier: NCT04692389|
Recruitment Status : Not yet recruiting
First Posted : December 31, 2020
Last Update Posted : January 5, 2021
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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)|
|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.|
|Estimated Study Start Date :||February 1, 2021|
|Estimated Primary Completion Date :||February 1, 2023|
|Estimated Study Completion Date :||March 31, 2023|
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
- 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.
- 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)).
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04692389
|Oncology Institute Of Southern Switzerland -radio oncology unit|
|Bellinzona, Canton Ticino, Switzerland, 6501|
|Contact: Loris Bonetti +41918118957 firstname.lastname@example.org|
|Contact: Giovanni Presta +41918118132 email@example.com|
|Sub-Investigator: Andrea Puliatti|
|Sub-Investigator: Dario Valcarenghi|
|Sub-Investigator: Angela Tolotti|
|Sub-Investigator: Francesco Martucci|
|Sub-Investigator: Davide Sari|