Radiation-induced DermatitisJALOSOME-01NCT05284487
Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel.
A study testing Jalosome® soothing gel in people with Radiation-induced Dermatitis, run by Welcare Industries SpA at 1 site in Italy.
Trial summary
Primary objective To investigate the effectiveness of Jalosome® compared with placebo in the prevention and treatment of RID in patients with HNC undergoing RT. Secondary objectives: To investigate the effectiveness of Jalosome® in reducing the maximum severity of RID compared with placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation-induced Dermatitis
- What is being tested?
- Jalosome® soothing gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteItaly
- Study dates
- 27 Mar 2023to Mar 2024
- 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
- Male and female subject aged ≥18 years old.
- Performance status 0-1.
- Diagnosis of HNC (epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinuses or salivary glands).
- Postoperative or curative RT (total radiation dose of at least 60 Gy), with or without concurrent chemotherapy.
- Willingness and ability to give informed consent and comply with study procedures.
Who cannot join
- Pregnant or lactating women.
- Previous RT on the head and neck area.
- Planned to receive concurrent cetuximab.
- Cutaneous and/or connective diseases (i.e. lupus erythematosus or scleroderma).
- Systemic diseases known to delay the skin healing process, such as diabetes mellitus or severe renal failure.
- Use of a tissue-equivalent bolus.
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- Use of over-the-counter topical medications containing steroids.
- Presence of rashes or unhealed wounds in the radiation field.
- Recent sun exposure (<1 month).
- Mental conditions that could adversely affect subject's adherence to the study.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS
Milan, 20133
Nicola Alessandro Iacovelli, MD, +39 02 2390, NicolaAlessandro.Iacovelli@istitutotumori.mi.it
About this study
Official title: Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel in the Prevention and Treatment of Radiation-induced Dermatitis in Patients With Head and Neck Cancer.
Primary objective
- To investigate the effectiveness of Jalosome® compared with placebo in the prevention and treatment of RID in patients with HNC undergoing RT.
Secondary objectives:
- To investigate the effectiveness of Jalosome® in reducing the maximum severity of RID compared with placebo.
- To investigate the effect of Jalosome®, compared with placebo, on patients' quality of life.
- To investigate safety and tolerability of Jalosome®.
- To investigate patient's compliance to Jalosome® treatment.
- To investigate patient's global satisfaction with Jalosome® treatment.
Read the detailed description
Primary endpoint:
- Mean time difference in development of G2 RID (according to CTCA) between Jalosome® and placebo arms. A median difference of at least 7 days is considered of clinical significance.
- Secondary endpoints:
- Proportion of subjects without G2 RID at the end of RT, in the Jalosome® and placebo arms.
- Proportion of subjects without G2 RID at different timepoints (week 5, week 6 and two weeks after the last radiation) in the Jalosome® and placebo arms.
- Worst skin toxicity during treatment and up to 2 weeks after the last radiation, according to CTCAE, in the Jalosome® and placebo arms.
- RID grade (mean and worst) on the RISRAS scale, assessed weekly, in the Jalosome® and placebo arms.
- Mean and worst score of PRO-Skindex-16 questionnaire performed weekly, in the Jalosome® and placebo arms.
- Mean pain measured by the 11-point NRS of the Brief Pain Inventory (BPI), as reported in patients' diary (daily) and assessed during visits (weekly), in the Jalosome® and placebo arms.
- Patient's compliance to Jalosome® treatment.
- Patient's global satisfaction with Jalosome® treatment.
- Jalosome® overall safety and tolerability.
Study design:
Monocentric, randomized, double-blind, placebo controlled clinical trial.
- Conditions
- Radiation-induced Dermatitis
- Being tested
- Jalosome® soothing gel, Placebo
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jalosome® soothing gelDevice
Jalosome® Soothing gel is a phospholipid based vesicular system based on hyaluronic acid (HA). HA supports the process of formation of extracellular matrix and collagen synthesis by fibroblasts, favoring the formation of a well-vascularized granulation tissue and thus accelerating the healing process. Jalosome® Soothing gel contains other active ingredients: Acetyl-L-carnitine which plays an important role as shuttle for energy production and is involved in cellular metabolism. It is an effective cytoprotective, anti-inflammatory, neuroprotective, metal chelator, anti-apoptotic and anti-oxidant agent. Allantoin is a key constituent of comfrey (Symphytum officinale L), it has moisturizing and keratolytic effect, increasing the water content of the extracellular matrix and enhancing desquamation of upper layers of dead skin cells. Hydrogenated phosphatidylcholine is a permeation enhancers, which increases the solubilization of active ingredients, improving their skin permeation ability.
PlaceboDevice
The placebo does not contain the active ingredients of Jalosome, only the co-formulants.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Jalosome® Soothing gel | Active comparator | Jalosome® soothing gel ((L-Acetyl Carnitine chloridrate, Allantoin, Hydrogenated phosphatidylcholine, Sodium Hyaluronate) will be applied to the irradiated area two times daily (morning after RT and evening). The first application will start in the morning after the first RT session and will continue up to two weeks after completion of RT.
Visit 1: Screening (days -7 to 0) Visit 2: Randomization and start of RT (day 1) Visit 3 -Visit 9/10: RT treatment Last visit: 2 weeks after last RT Receives: Device: Jalosome® soothing gel |
| Group 2: Placebo | Placebo comparator | Placebo will be applied to the irradiated area two times daily (morning after RT and evening). The first application will start in the morning after the first RT session and will continue up to two weeks after completion of RT.
Visit 1: Screening (days -7 to 0) Visit 2: Randomization and start of RT (day 1) Visit 3 -Visit 9/10: RT treatment Last visit: 2 weeks after last RT Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to development of G2 RID
Mean number of days in development of G2 RID (according to CTCA), in the Jalosome® and placebo arms.
Measured: 9 weeks
Secondary outcomes (8)
Subjects without G2 RID at the end of RT
Number and percentage of subjects without G2 RID at the end of RT, in the Jalosome® and placebo arms..
Measured: 9 weeks
Subjects without G2 RID at different timepoints
Number and percentage of subjects without G2 RID at different timepoints (week 5, week 6 and two weeks after the last radiation) in the Jalosome® and placebo arms.
Measured: 9 weeks
Worst skin toxicity
Number and percentage of subjects with worst skin toxicity G3, G2 and G1 RID according to CTCAE v.4.0, during treatment and up to 2 weeks after the last administration of RT, in the Jalosome® and placebo arms.
Measured: 9 weeks
RID grade on the RISRAS
Mean RID grade on the Radiation-Induced Skin Reaction Assessment Scale scale (RISRAS), assessed weekly, in the Jalosome® and placebo arms.
RISRAS score varies from 0 to 36, where 0 is normal skin/no symptoms at all and 36 is the worst conditions in terms of erythema-Dry desquamation - Moist desquamation - necrosis of derma (14 points) and very severe symptoms (12 points).
Measured: 9 weeks
PRO-Skindex-16 questionnaire score
Mean score of each item (16 items) of PRO-Skindex-16 questionnaire performed weekly, in the Jalosome® and placebo arms. Each item is about skin discomfort, ancd the scores vary from 0 (no discomfort) to 6 (full discomfort).
Measured: 9 weeks
Pain measured by NRS
Mean pain measured by the 11-point Numeric rating scale (NRS) of the Brief Pain Inventory (BPI), as reported in patients' diary (daily) and assessed during visits (weekly), in the Jalosome® and placebo arms.
NRS score varies from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
Measured: 9 weeks
Compliance
Number and percentage of patients with compliance to Jalosome® treatment ≥80%.
Measured: 9 weeks
Adverse events
Number and percentage of adverse events by grade, according to the CTCAE v.4.0, and relationship with the treatment.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start27 Mar 2023
- Primary completionFeb 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-induced DermatitisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Welcare Industries SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicola Alessandro Iacovelli, Principal investigator, Fondazione IRCCS ISTITUTO NAZIONALE TUMORI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284487
- Sponsor's protocol ID
- JALOSOME-01
- Acronym
- JALOSOME-01
- Status last verified
- Mar 2023
- First submitted
- 4 Feb 2022
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel in the Prevention and Treatment of Radiation-induced Dermatitis in Patients With Head and Neck Cancer.
- ClinicalTrials.gov ID
- NCT05284487
- Acronym / sponsor ID
- JALOSOME-01 / JALOSOME-01
- Conditions
- Radiation-induced Dermatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Welcare Industries SpAIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 17 Mar 2022 (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.
Primary objective
- To investigate the effectiveness of Jalosome® compared with placebo in the prevention and treatment of RID in patients with HNC undergoing RT.
Secondary objectives:
- To investigate the effectiveness of Jalosome® in reducing the maximum severity of RID compared with placebo.
- To investigate the effect of Jalosome®, compared with placebo, on patients' quality of life.
- To investigate safety and tolerability of Jalosome®.
- To investigate patient's compliance to Jalosome® treatment.
- To investigate patient's global satisfaction with Jalosome® treatment.
Detailed description
Primary endpoint:
- Mean time difference in development of G2 RID (according to CTCA) between Jalosome® and placebo arms. A median difference of at least 7 days is considered of clinical significance.
- Secondary endpoints:
- Proportion of subjects without G2 RID at the end of RT, in the Jalosome® and placebo arms.
- Proportion of subjects without G2 RID at different timepoints (week 5, week 6 and two weeks after the last radiation) in the Jalosome® and placebo arms.
- Worst skin toxicity during treatment and up to 2 weeks after the last radiation, according to CTCAE, in the Jalosome® and placebo arms.
- RID grade (mean and worst) on the RISRAS scale, assessed weekly, in the Jalosome® and placebo arms.
- Mean and worst score of PRO-Skindex-16 questionnaire performed weekly, in the Jalosome® and placebo arms.
- Mean pain measured by the 11-point NRS of the Brief Pain Inventory (BPI), as reported in patients' diary (daily) and assessed during visits (weekly), in the Jalosome® and placebo arms.
- Patient's compliance to Jalosome® treatment.
- Patient's global satisfaction with Jalosome® treatment.
- Jalosome® overall safety and tolerability.
Study design:
Monocentric, randomized, double-blind, placebo controlled clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Jalosome® Soothing gel | Active comparator | Device: Jalosome® soothing gelJalosome® soothing gel ((L-Acetyl Carnitine chloridrate, Allantoin, Hydrogenated phosphatidylcholine, Sodium Hyaluronate) will be applied to the irradiated area two times daily (morning after RT and evening). The first application will start in the morning after the first RT session and will continue up to two weeks after completion of RT. Visit 1: Screening (days -7 to 0) Visit 2: Randomization and start of RT (day 1) Visit 3 -Visit 9/10: RT treatment Last visit: 2 weeks after last RT |
| Group 2: Placebo | Placebo comparator | Device: PlaceboPlacebo will be applied to the irradiated area two times daily (morning after RT and evening). The first application will start in the morning after the first RT session and will continue up to two weeks after completion of RT. Visit 1: Screening (days -7 to 0) Visit 2: Randomization and start of RT (day 1) Visit 3 -Visit 9/10: RT treatment Last visit: 2 weeks after last RT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subject aged ≥18 years old.
- Performance status 0-1.
- Diagnosis of HNC (epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinuses or salivary glands).
- Postoperative or curative RT (total radiation dose of at least 60 Gy), with or without concurrent chemotherapy.
- Willingness and ability to give informed consent and comply with study procedures.
Key exclusion criteria (10 listed)
- Pregnant or lactating women.
- Previous RT on the head and neck area.
- Planned to receive concurrent cetuximab.
- Cutaneous and/or connective diseases (i.e. lupus erythematosus or scleroderma).
- Systemic diseases known to delay the skin healing process, such as diabetes mellitus or severe renal failure.
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 gelJalosome® Soothing gel is a phospholipid based vesicular system based on hyaluronic acid (HA). HA supports the process of formation of extracellular matrix and collagen synthesis by fibroblasts, favoring the formation of a well-vascularized granulation tissue and thus accelerating the healing process. Jalosome® Soothing gel contains other active ingredients: Acetyl-L-carnitine which plays an important role as shuttle for energy production and is involved in cellular metabolism. It is an effective cytoprotective, anti-inflammatory, neuroprotective, metal chelator, anti-apoptotic and anti-oxidant agent. Allantoin is a key constituent of comfrey (Symphytum officinale L), it has moisturizing and keratolytic effect, increasing the water content of the extracellular matrix and enhancing desquamation of upper layers of dead skin cells. Hydrogenated phosphatidylcholine is a permeation enhancers, which increases the solubilization of active ingredients, improving their skin permeation ability. | Device | Group 1: Jalosome® Soothing gel |
| PlaceboThe placebo does not contain the active ingredients of Jalosome, only the co-formulants. | Device | Group 2: Placebo |
Primary outcome
Time to development of G2 RID
Time frame: 9 weeks
Mean number of days in development of G2 RID (according to CTCA), in the Jalosome® and placebo arms.
8 secondary outcomes
Subjects without G2 RID at the end of RT
Time frame: 9 weeks
Subjects without G2 RID at different timepoints
Time frame: 9 weeks
Worst skin toxicity
Time frame: 9 weeks
RID grade on the RISRAS
Time frame: 9 weeks
PRO-Skindex-16 questionnaire score
Time frame: 9 weeks
Pain measured by NRS
Time frame: 9 weeks
Compliance
Time frame: 9 weeks
Adverse events
Time frame: 9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
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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.
Nicola Alessandro Iacovelli principal investigator
Fondazione IRCCS ISTITUTO NAZIONALE TUMORI
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 Radiation-induced Dermatitis, run by Welcare Industries SpA at 1 site in Italy.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 26 Feb 2024. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Gobbino (+39 (0)763 316353, r&s@welcaremedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to development of G2 RID (time frame: 9 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 26 Feb 2024.