Clinical trial · Interventional
A Novel Skin Barrier Protectant for Acute Radiodermatitis
Evaluating the Effectiveness of a Novel Skin Barrier Protectant in the Prevention and Management of Acute Radiodermatitis in Patients With Head and Neck Cancer: a Prospective Cohort Study With Historical Controls
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Covid-19
Summary
Brief summary (as posted)
Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing radiotherapy (RT). To date, there is still no general approved guideline for the prevention and management of acute radiodermatitis. The 3M™ Cavilon™ Advanced Skin Protectant is a novel skin barrier protectant that acts as a physical barrier against abrasion, moisture, and irritants. Moreover, it enables an environment for wound healing. The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the prevention and management of ARD in patients with head and neck cancer.
Conditions
Conditions (5)
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 |
| Radiation Dermatitis | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
| Radiodermatitis | — | UNRESOLVED | — |
| Skin Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cavilon Advanced Skin Protectant | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cavilon Advanced Skin Protectant
- description
- Cavilon Advanced Skin Protectant forms a film barrier intended to protect intact or damaged skin. It is effective in conditions where skin is frequently or continuously exposed to moisture and caustic irritants such as feces, digestive fluids, wound drainage and urine. Cavilon Advanced Skin Protectant also can be used in areas exposed to friction and shear from bedding, clothing, shoes or any other material that would rub against the skin. The skin barrier protectant will be applied on the irradiated skin from the third week of radiotherapy until 1 week after the final radiotherapy session.
- interventionNames
- Device: Cavilon Advanced Skin Protectant
Primary outcomes (12)
- measure
- Radiodermatitis grading
- timeFrame
- Day 1
- description
- National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of head and neck squamous cell carcinomas (HNSCC) starting in the lip, salivary gland, oral cavity (mouth), nasal cavity (inside the nose), paranasal sinuses, pharynx, or larynx. * Scheduled for bilateral neck radiotherapy (\>60 Gy) with or without concomitant chemotherapy either as primary or as post-operative treatment to the head and neck region * Age ≥ 18 years * Able to comply to the study protocol * Able to sign written informed consent * Signed written informed consent Exclusion Criteria: * Previous irradiation to the head and/or neck region * Metastatic disease * Patients with pre-existing skin rash, ulceration or open wound in the treatment area * Patients with known allergic and other systemic skin diseases even when not directly affecting irradiated fields * Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator * Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator * Patients using high doses of non-steroidal anti-inflammatory drugs * Patients allergic to the ingredients of the 3M™ Cavilon™ Advanced Skin Protectant
References
Publications (0)
Data not yet available