Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel. (JALOSOME-01)
Radiation-induced Dermatitis
About this trial
This is an interventional prevention trial for Radiation-induced Dermatitis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Group 1: Jalosome® Soothing gel
Group 2: Placebo
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
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