Clinical trial • Phase II | Phase IV • Other
DEXAMETHASONE ACETATE for Benign parotid tumor
Phase II | Phase IV trial of DEXAMETHASONE ACETATE for Benign parotid tumor. open-label, none/not specified-controlled. 10 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Benign parotid tumor
- Trial Stage
- Phase II | Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 01-12-2025
- First CTIS Authorization Date
- 19-03-2026
Trial design
open-label, none/not specified-controlled Phase II | Phase IV trial across 1 site in France.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 10
- Trial Duration For Participant
- 15
Eligibility
Recruits 10 No vulnerable population selected; participants must be age ≥ 18 years. Informed consent is by adult participants (subject information and informed consent form documents L1_SIS and ICF adult are provided). No assent procedures described..
- Vulnerable Population
- No vulnerable population selected; participants must be age ≥ 18 years. Informed consent is by adult participants (subject information and informed consent form documents L1_SIS and ICF adult are provided). No assent procedures described.
Inclusion criteria
- {"criterion_text":"- Validated surgical indication for partial parotidectomy for parotid tumor.\n- Age ≥ 18 years\n- For patients of childbearing age, active contraception method.\n- Person affiliated with or beneficiary of a social security system."}
Exclusion criteria
- {"criterion_text":"- History of allergic reaction to aminoamide local anesthetics.\n- Severe neurological history (epilepsy, peripheral neuropathies).\n- History of cardiovascular risk factors (severe hypertension, arrhythmias, complete or incomplete heart block, heart failure, coronary artery disease, treatment with type 2 antiarrhythmic drugs).\n- Severe liver or kidney disease (severe liver or kidney failure).\n- Acidosis, sepsis."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Collection within 15 days of injection of any local side effects related to the injection of bupivacaine.","definition_or_measurement_approach":"Collection of any local side effects related to the injection of bupivacaine within 15 days following the injection."}
Secondary endpoints
- {"endpoint_text":"- Pain level (VAS 0-10) on D0, D1, D2, D4, D6, D9, D12, and at the D15 consultation.","definition_or_measurement_approach":"Pain measured using Visual Analog Scale (VAS) 0-10 at specified post-operative days (D0, D1, D2, D4, D6, D9, D12) and at day 15 consultation."}
- {"endpoint_text":"- Collection of data on the occurrence of salivary fistula or clinical sialoma at the post-operative consultation on D15 : yes/no.","definition_or_measurement_approach":"Occurrence of salivary fistula or clinical sialoma assessed at the D15 post-operative consultation and recorded as yes/no."}
- {"endpoint_text":"- Administration of a questionnaire on the quality of healing (dehiscence, inflammation, infection) at the 15-day follow-up.","definition_or_measurement_approach":"Questionnaire administered at 15-day follow-up assessing wound healing quality (dehiscence, inflammation, infection)."}
- {"endpoint_text":"- Feasibility questionnaire, to be completed by the surgeon on the day of surgery.","definition_or_measurement_approach":"Surgeon-completed feasibility questionnaire administered on the day of surgery."}
Recruitment
- Planned Sample Size
- 10
- Recruitment Window Months
- 17
- Consent Approach
- Informed consent obtained from adult participants (age ≥18) using the adult subject information sheet and informed consent form (documents: L1_SIS and ICF adult). No assent or minor-specific consent described.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 10
France
- Earliest CTIS Part Ii Submission Date
- 20-02-2026
- Latest Decision Or Authorization Date
- 19-03-2026
- Processing Time Days
- 27
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- O.R.L
- Principal Investigator Name
- Benjamin LALLEMANT
- Principal Investigator Email
- benjamin.lallemant@chu-nimes.fr
- Contact Person Name
- Benjamin LALLEMANT
- Contact Person Email
- benjamin.lallemant@chu-nimes.fr
- Number Of Participants
- 10
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire De Nimes
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- DEXAMETHASONE
- Active Substance
- DEXAMETHASONE ACETATE
- Modality
- Small molecule
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Authorisation Status
- MarketingAuthNumber: -; prodAuthStatus: 2
- Starting Dose
- 2 mg
- Dose Levels
- 2 mg
- Frequency
- Single administration (intra-parotid injection)
- Maximum Dose
- 2 mg
- Investigational Product Name
- BUPIVACAINE
- Active Substance
- BUPIVACAINE HYDROCHLORIDE, EPINEPHRINE
- Modality
- Small molecule
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Authorisation Status
- MarketingAuthNumber: -; prodAuthStatus: 2
- Starting Dose
- 100 mg
- Dose Levels
- 100 mg
- Frequency
- Single administration (intra-parotid injection)
- Maximum Dose
- 100 mg
- Combination Treatment
- Yes
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