Clinical trial · Interventional
Preemptive Treatment With XONRID to Reduce Radiation Induced Dermatitis in Head and Neck Cancer Patients
Preemptive Treatment With XONRID a Medical Device to Reduce Radiation Induced Dermatitis in Head and Neck Cancer Patients Receiving Curative Treatment
NCT02261181CI-TRIAL-00054168completedN/AClinicalTrials.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)
There is a strong need to study products with a preemptive role in radiation dermatitis development, with a trial design taking in account patient subjective evaluation and compliance. XONRID is a promising device for radiation high grade dermatitis prevention; it is a topical gel that prevents and treats skin symptoms such as erythema, itching, burning sensation and pruritus, induced by radiotherapy or other causes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| XONRID | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- XONRID
- description
- Patients will be treated with XONRID + standard of care (SOC) preemptive treatment adopted during radiation treatment for head and neck cancer patients. Patients will be instructed to apply the study cream (XONRID) on the irradiated area two times daily, the first application 1-2 h after the morning radiotherapy session, the second in the evening, starting on the first day of irradiation and continuing until 2 weeks after the completion of the radiation treatments or the development of Grade 3 or 4 skin toxicity. When G3 toxicity will occur the patient will be discontinued from the study medication and the skin toxicity will be managed according to internal guidelines. The use of other topical medications for the treatment of dermatitis will be not permitted during the study.
- interventionNames
- Device: XONRID
Primary outcomes (1)
- measure
- Worst skin toxicity
- timeFrame
- 14 months
- description
- Worst skin toxicity during treatment and until 2 weeks after according to CTCAE , as assessed independently by 2 physicians
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \> 18 years * Performance status \< 2 * Epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus and salivary glands * Planned to receive at least 50 Gy on one side of the neck with at least the 2nd level of neck nodes irradiated * Postoperative or curative radiation treatment * Concurrent platinum based chemotherapy is accepted, but not mandatory * Conventional fractionation (1.8-2.12 GY per fraction, one daily fraction, 5 fractions a week ) Exclusion Criteria: * Pregnant or lactating women * Planned to receive concurrent cetuximab * Previous radiation therapy on the head and neck area * Cutaneous and connettive 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 * Use of over-the-counter topical medications containing steroids * Presence of rashes or unhealed wounds in the radiation field * Recent sun exposure * Mental conditions that could adversely affect patients' adherence to the study
References
Publications (1)
- DERIVEDIngargiola R, De Santis MC, Iacovelli NA, Facchinetti N, Cavallo A, Ivaldi E, Dispinzieri M, Franceschini M, Giandini C, Romanello DA, Di Biaso S, Sabetti M, Locati L, Alfieri S, Bossi P, Guglielmo M, Macchi F, Lozza L, Valdagni R, Fallai C, Pignoli E, Orlandi E. A monocentric, open-label randomized standard-of-care controlled study of XONRID(R), a medical device for the prevention and treatment of radiation-induced dermatitis in breast and head and neck cancer patients. Radiat Oncol. 2020 Aug 13;15(1):193. doi: 10.1186/s13014-020-01633-0. PMID 32791985