An interventional study of Xonrid® gel and Standard of Care in Radiodermatitis and Quality of Life, sponsored by Helsinn Healthcare SA. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-16.
Sponsored by Helsinn Healthcare SA · Not applicable, Interventional, and Other
To evaluate the performance of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head \& neck cancer patients.
The aim of this clinical investigation is to evaluate if the use of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head \& neck cancer patients can be a valid support, when compared to the Standard of Care as defined by MASCC (Multinational Association for Supportive Care in Cancer) guidelines.
127 studies on the registry are indexed under Radiodermatitis; 26 are open to participants now.
This study's enrollment of 80 is above the median of 55 across 104 interventional studies indexed under Radiodermatitis.
Browse Radiodermatitis studies →Helsinn Healthcare SA is the lead sponsor of 32 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Xonrid® is a medical device for radiation dermatitis
Device: Xonrid® gel · Other: Standard of Care
Standard of care suggested by MASCC guidelines
Device: Xonrid® gel
Water based gel for the management of toxicity skin symptoms induced by Radiotherapy
Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines
Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5
The primary endpoint of this clinical investigation was the proportion of patients without G2 radiation dermatitis (radiation dermatitis \< G2) at week 5
Time frame: 5 weeks over 7 weeks
Median Time to G2 Radiodermatitis Development
Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation
Time frame: 5 weeks over 7 weeks
The Proportion of Patients Without G2 Radiation Dermatitis at Week 6 for Both Cancer Sites, at Week 7 for Head & Neck Cancer and 2 Weeks After the Last Radiation for Both Cancer Sites
Definition of RD grade according to CTCAE v4.0 Scale by trained physicinans
Time frame: 5 weeks over 7 weeks
The Worst Skin Toxicity During Treatment and Until 2 Weeks After the Last Radiation
Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation for both cancer sites, at week 7 for head \& neck cancer and 2 weeks after the last radiation for both cancer sites.
Time frame: 6 weeks over 7 weeks
The Changes in Skin Erythema and Pigmentation, According to the ITA (Individual Typological Angle) Degrees Measured Throughout the Study.
The changes in skin erythema and pigmentation, according to the ITA (individual Typological Angle) degrees measured throughout the study by the Investigators.
Time frame: Follow-up: 2 weeks after the completion of radiation treatment
The Changes in Trans-epidermal Water Loss (TEWL) Assessed Through the Evaporation
Changes of skin characteristics in terms of TEWL according to the progression of the Radiotherapy and consequent erythema
Time frame: weekly during teratment (7 weeks)
The Mean and Worst Score of Skindex-16 Questionnaire
Evaluate the patient's QoL changes occurred during the RT trough the validated self-assessed questionnaire Skindex-16
Time frame: 5 weeks over 7 weeks
The Compliance to Experimental Treatment, Assessed Through the Number of Daily Product Applications Reported on the Patient's Diary, Compared to the Amount of Used Product
Compliance is based on the total amount ( weight) of Xonrid used over the treatment period
Time frame: 5 weeks over 7 weeks
The Patients' Global Satisfaction With Treatment, Assessed by Likert Scale
Global patient's satisfaction recorded by the Linkert Scale
Time frame: 6 weeks over 7 weeks
FPI: June 2017 LPO: July 2018
| Milestone | Breast Cancer Group: Xonrid+SOC | Breast Cancer Group: SOC | Head and Neck Cancer Group: Xonrid + SOC | Head and Neck Cancer Group: SOC |
|---|---|---|---|---|
| Started | 20 | 20 | 20 | 20 |
| Completed | 17 | 12 | 14 | 8 |
| Not completed | 3 | 8 | 6 | 12 |
| Withdrew: Grade =>3 skin toxicity | 1 | 4 | 6 | 5 |
| Withdrew: Adverse event | 1 | 1 | 0 | 1 |
| Withdrew: Lack of compliance to study or assessmen | 0 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 | 0 | 3 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 3 |
The primary endpoint of this clinical investigation was the proportion of patients without G2 radiation dermatitis (radiation dermatitis \< G2) at week 5
| participants | Breast Cancer Group: Xonrid+SOC | Breast Cancer Group: SOC | Head and Neck Cancer Group: Xonrid + SOC | Head and Neck Cancer Group: SOC |
|---|---|---|---|---|
| Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5 | 10 | 5 | 13 | 11 |
Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation
Results for this outcome have not been posted.
Definition of RD grade according to CTCAE v4.0 Scale by trained physicinans
Results for this outcome have not been posted.
Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation for both cancer sites, at week 7 for head \& neck cancer and 2 weeks after the last radiation for both cancer sites.
Results for this outcome have not been posted.
The changes in skin erythema and pigmentation, according to the ITA (individual Typological Angle) degrees measured throughout the study by the Investigators.
Results for this outcome have not been posted.
Changes of skin characteristics in terms of TEWL according to the progression of the Radiotherapy and consequent erythema
Results for this outcome have not been posted.
Evaluate the patient's QoL changes occurred during the RT trough the validated self-assessed questionnaire Skindex-16
Results for this outcome have not been posted.
Compliance is based on the total amount ( weight) of Xonrid used over the treatment period
Results for this outcome have not been posted.
Global patient's satisfaction recorded by the Linkert Scale
Results for this outcome have not been posted.
Collected over 13 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Breast Cancer: Xonrid® +SOC | 0/20 (0%) | 1/20 (5%) | 1/20 (5%) |
| Breast Cancer: Standard Of Care | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Head and Neck Cancer: Xonrid + SOC | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Head and Neck Cancer: Standard of Care | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Event | Breast Cancer: Xonrid® +SOC | Breast Cancer: Standard Of Care | Head and Neck Cancer: Xonrid + SOC | Head and Neck Cancer: Standard of Care |
|---|---|---|---|---|
| pruritusSkin and subcutaneous tissue disorders | 1/20 | 0/20 | 0/20 | 0/20 |
| Event | Breast Cancer: Xonrid® +SOC | Breast Cancer: Standard Of Care | Head and Neck Cancer: Xonrid + SOC | Head and Neck Cancer: Standard of Care |
|---|---|---|---|---|
| Ear InfectionInfections and infestations | 1/20 | 0/20 | 0/20 | 0/20 |
Descriptive statistics of all relevant variables were performed
| Age, Continuous(years) | Breast Cancer Group: Xonrid+SOC | Breast Cancer Group: SOC | Head and Neck Cancer Group: Xonrid + SOC | Head and Neck Cancer Group: SOC | Total |
|---|---|---|---|---|---|
| Mean | 49.56 ± 4.80 | 49.01 ± 4.54 | 55.73 ± 12.46 | 59.49 ± 12.34 | 53.45 ± 8.52 |
| Sex: Female, Male(Participants) | Breast Cancer Group: Xonrid+SOC | Breast Cancer Group: SOC | Head and Neck Cancer Group: Xonrid + SOC | Head and Neck Cancer Group: SOC | Total |
|---|---|---|---|---|---|
| Female | 20 | 20 | 4 | 4 | 48 |
| Male | 0 | 0 | 16 | 16 | 32 |
| Race/Ethnicity, Customized(Caucasian) | Breast Cancer Group: Xonrid+SOC | Breast Cancer Group: SOC | Head and Neck Cancer Group: Xonrid + SOC | Head and Neck Cancer Group: SOC | Total |
|---|---|---|---|---|---|
| Number | 20 | 20 | 20 | 20 | 80 |
| Region of Enrollment(participants) | Breast Cancer Group: Xonrid+SOC | Breast Cancer Group: SOC | Head and Neck Cancer Group: Xonrid + SOC | Head and Neck Cancer Group: SOC | Total |
|---|---|---|---|---|---|
| Italy | 20 | 20 | 20 | 20 | 80 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2017 to primary completion in Feb 2019, 20 months.
Results were first posted in Dec 2020, 1 year 9 months after primary completion.
Of 39 interventional studies with no phase under Radiodermatitis, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 54. This study's 20 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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