RadiodermatitisNCT04692389
Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis.
A study testing Jalosome soothing gel in people with Radiodermatitis and Oncology, run by Welcare Industries SpA at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiodermatitis, Oncology, Quality of Life
- What is being tested?
- Jalosome soothing gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Oncology Institute Of Southern Switzerland -radio oncology unit
Bellinzona, Canton Ticino, 6501
About this study
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.
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.
Read the 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.
- Conditions
- Radiodermatitis, Oncology, Quality of Life, Pain
- Being tested
- Jalosome soothing gel
- Keywords
- radiodermatitis, oncology, quality of life, pain, wound healing
- Medical subject headings
- Radiodermatitis, Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jalosome soothing gelDevice
Also called No other intervention
This study has not got other intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Jalosome soothing gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (2)
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)).
Measured: 8 weeks
Skindex questionnaire - 16 for quality of life
Quality of life will then be assessed as a second enpoint, using the Skindex questionnaire - 16
Measured: at the beginning, after 4 weeks and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Feb 2021
- Primary completion1 Feb 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Why it stopped: difficulties in patients recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiodermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Welcare Industries SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oncology Institute of Southern Switzerland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692389
- Sponsor's protocol ID
- Welcare 012020
- Status last verified
- Jan 2022
- First submitted
- 29 Dec 2020
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04692389
- Acronym / sponsor ID
- Welcare 012020
- Conditions
- Radiodermatitis, Oncology, Quality of Life, Pain
- Keywords
- radiodermatitis, oncology, quality of life, pain, wound healing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: difficulties in patients recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Welcare Industries SpAIndustry (pharma, biotech, devices)
- Collaborators
- Oncology Institute of Southern Switzerland
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Jalosome® Soothing gel | Experimental | Device: Jalosome soothing gelThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jalosome soothing gelAlso: No other interventionThis study has not got other intervention | Device | Jalosome® Soothing gel |
Primary outcome
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.
2 secondary outcomes
Pain quality and intensity
Time frame: 8 weeks
Skindex questionnaire - 16 for quality of life
Time frame: at the beginning, after 4 weeks and after 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jalosome soothing gel in people with Radiodermatitis and Oncology, run by Welcare Industries SpA at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 2 or 3 radiodermatitis healing (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.