Clinical trial · Interventional
Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Xonrid®
Monocenter, Open Label Clinical Investigation on the Treatment With Xonrid®, a Medical Device for the Prevention and Treatment of Radiotherapy-induced Dermatitis, in Breast and Head & Neck Cancer Patients Receiving Curative Treatment.
NCT03255980CI-TRIAL-00048838completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the performance of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head \& neck cancer patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Quality of Life | — | UNRESOLVED | — |
| Radiodermatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard of Care | Other | — | UNRESOLVED |
| Xonrid® gel | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Xonrid®
- description
- Xonrid® is a medical device for radiation dermatitis
- interventionNames
- Device: Xonrid® gel
- Other: Standard of Care
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care
- description
- Standard of care suggested by MASCC guidelines
- interventionNames
- Device: Xonrid® gel
Primary outcomes (1)
- measure
- Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5
- timeFrame
- 5 weeks over 7 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male and female which are 18 years of age or older 2. Performance status \< 2 3. Epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus and salivary glands or breast cancer, planned to receive a total dose of at least 50 Gy 4. Postoperative or curative radiation treatment 5. Concurrent chemotherapy is accepted, in head \& neck cancer patients 6. Patients willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the Clinical Investigation Plan tests and procedures. Exclusion Criteria: 1. Pregnant or lactating women 2. Planned to receive concurrent cetuximab 3. Previous radiation therapy on the head and neck area or breast and thorax areas 4. Cutaneous and connective diseases (i.e. lupus erythematosus or scleroderma) 5. Systemic diseases known to delay the skin healing process such as diabetes mellitus or severe renal failure 6. Use of a tissue-equivalent bolus 7. Use of over-the-counter topical medications containing steroids 8. Presence of rashes or unhealed wounds in the radiation field 9. Recent sun exposure 10. Mental conditions that could adversely affect patients' adherence to the study.
References
Publications (0)
Data not yet available
No reference posted for this study.