Clinical trial · Interventional
Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel.
Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel in the Prevention and Treatment of Radiation-induced Dermatitis in Patients With Head and Neck Cancer.
- 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)
Primary objective \- To investigate the effectiveness of Jalosome® compared with placebo in the prevention and treatment of RID in patients with HNC undergoing RT. Secondary objectives: * To investigate the effectiveness of Jalosome® in reducing the maximum severity of RID compared with placebo. * To investigate the effect of Jalosome®, compared with placebo, on patients' quality of life. * To investigate safety and tolerability of Jalosome®. * To investigate patient's compliance to Jalosome® treatment. * To investigate patient's global satisfaction with Jalosome® treatment.
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 |
|---|---|---|---|
| Radiation-induced Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Jalosome® soothing gel | Device | — | UNRESOLVED |
| Placebo | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group 1: Jalosome® Soothing gel
- description
- Jalosome® soothing gel ((L-Acetyl Carnitine chloridrate, Allantoin, Hydrogenated phosphatidylcholine, Sodium Hyaluronate) will be applied to the irradiated area two times daily (morning after RT and evening). The first application will start in the morning after the first RT session and will continue up to two weeks after completion of RT. Visit 1: Screening (days -7 to 0) Visit 2: Randomization and start of RT (day 1) Visit 3 -Visit 9/10: RT treatment Last visit: 2 weeks after last RT
- interventionNames
- Device: Jalosome® soothing gel
- type
- PLACEBO_COMPARATOR
- label
- Group 2: Placebo
- description
- Placebo will be applied to the irradiated area two times daily (morning after RT and evening). The first application will start in the morning after the first RT session and will continue up to two weeks after completion of RT. Visit 1: Screening (days -7 to 0) Visit 2: Randomization and start of RT (day 1) Visit 3 -Visit 9/10: RT treatment Last visit: 2 weeks after last RT
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female subject aged ≥18 years old. * Performance status 0-1. * Diagnosis of HNC (epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinuses or salivary glands). * Postoperative or curative RT (total radiation dose of at least 60 Gy), with or without concurrent chemotherapy. * Willingness and ability to give informed consent and comply with study procedures. Exclusion Criteria: * Pregnant or lactating women. * Previous RT on the head and neck area. * Planned to receive concurrent cetuximab. * Cutaneous and/or connective 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 (\<1 month). * Mental conditions that could adversely affect subject's adherence to the study.
References
Publications (0)
Data not yet available