Status:
UNKNOWN
Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel.
Lead Sponsor:
Welcare Industries SpA
Conditions:
Radiation-induced Dermatitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 invest...
Detailed Description
Primary endpoint: * Mean time difference in development of G2 RID (according to CTCA) between Jalosome® and placebo arms. A median difference of at least 7 days is considered of clinical significance...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT05284487
Start Date
March 27 2023
End Date
March 1 2024
Last Update
February 26 2024
Active Locations (1)
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1
IRCCS
Milan, Italy, 20133