Clinical trial · Interventional
Jalosome® Soothing Gel Efficacy Grade 2 or 3 Radiodermatitis.
The Efficacy of the Medical Device Jalosome® Soothing Gel in the Healing of Grade of 2 or 3 Radiodermatitis, Pain Intensity Reduction, as Well as Improvement of QoL in Oncology Patients: a Pilot Study.
NCT04692389CI-TRIAL-00056385withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): difficulties in patients recruitment
Summary
Brief summary (as posted)
Testing the efficacy of the Jalosome® Soothing gel in 2 or 3 grade radiodermatitis healing in oncological patients. The investigators would like to know also the efficacy of the device on quality of life and pain.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oncology | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Radiodermatitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Jalosome soothing gel | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Jalosome® Soothing gel
- description
- The medical device will be applied by the patient himself, after appropriate training carried out by the nurse, twice a day, in the quantity necessary to cover the lesion (0.2g of gel /16 cm2 of skin (one spray), repeated as many times as necessary to cover the entire lesion). The treatment will last 8 weeks. The medical device will be delivered in the quantity strictly necessary to carry out the therapies between visits, in order to monitor its use. Patients will be seen weekly by the nurse, in order to ensure the best continuity of care and promote adherence to the study. Patients will be asked to keep a weekly diary, in which they will report their level of pain, analgesic therapy and medication. Nurses will be available for telephone counselling, if necessary.
- interventionNames
- Device: Jalosome soothing gel
Primary outcomes (1)
- measure
- Grade 2 or 3 radiodermatitis healing
- timeFrame
- 8 weeks
- description
- The primary endpoint is the number of grade 2 or 3 radiodermatitis healed by the application of Jalosome® soothing gel during the observation period, out of the total number of patients treated. This endpoint will be assessed by photographic documentation of lesion improvement and healing and with the aid of the RGOT scale (which should regress from grade 2 or 3 to grade 0 or 1). The time to regression of the lesion will also be monitored on this same endpoint in order to establish the rate of efficacy of the product against grade 2 and 3 lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged ≥18 years * Patients with cancer\* undergoing radiotherapy treatment * Patients with grade 2 or 3 radiotherapy lesions who are naive to radiodermatitis treatment or unresponsive to previous treatment * Patients who have given written informed consent * Patients expected to be followed at the centre for at least 8 weeks * Patients with Karnofsky Performance Status(KPS) scale ≥ 40 Exclusion Criteria: * Patients with grade 1 and grade IV radiodermatitis * Patients with known intolerance to the components in Jalosome® soothing gel * Patients who have already received radiotherapy in the past on the irradiated area * Patients with cognitive impairment that does not allow adequate compliance with the protocol * Patients with brain metastases * Pregnant or lactating patients * Patients with KPS \< 40
References
Publications (0)
Data not yet available
No reference posted for this study.