Status:
UNKNOWN
Clinical Study on Hyaluronic Acid With Lidocaine for the Treatment of Moderate to Severe Nasolabial Folds
Lead Sponsor:
Centro Medico Polispecialistico
Conditions:
Nasolabial Folds
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This will be a pre-CE mark controlled, prospective, randomized, blinded evaluator, single centre, split-face clinical investigation. Each subject will receive both medical devices under investigation...
Detailed Description
This will be a pre-CE mark controlled, prospective, randomized, blinded evaluator, single centre, split-face clinical investigation. Each subject will receive both medical devices under investigation...
Eligibility Criteria
Inclusion
- Presence of moderate to severe nasolabials folds (WSRS grade 3-4);
- Reasonable potential benefit from correction;
- Subjects able to understand the full nature and the purpose of the investigation, including possible risks and side effects, able to cooperate with the Investigator and to comply with the requirements of the entire investigation (ability to attend all the planned investigation visits according to the time limits included) based on Investigator's judgement;
- Subjects must voluntarily give written informed consent, adhere to the protocol and report events and concomitant medication for the entire duration of investigation.
Exclusion
- Pregnant (as determined by a urine pregnancy test at the screening visit) or lactating women. For the entire duration of the investigation, female subjects of childbearing potential (i.e., not permanently sterilised - post hysterectomy or tubal ligation status - or not postmenopausal from at least one year) must adopt an appropriate method of contraception according to the definition of Note 3 of ICH M3 Guideline;
- Prior treatment of the face (e.g. other permanent or biodegradable injectable fillers or surgical correction such as a face-lift, etc.) within 3 months prior to entry into the study or planned to undergo such therapy during the study;
- Previous tissue augmentation with permanent implants (e.g., silicone) in the area to be treated;
- Presence of active inflammation, infection (acne, herpes, dermatitis, etc.) or unhealed wound of the face;
- Presence of varices in the area to be treated;
- History of hypertrophic scarring;
- Medical history or clinical examination positive for metabolic or endocrine serious diseases (e.g. uncontrolled diabetes or diabetes complications), anaphylaxis, severe allergies, immune disorders affecting the skin, other local or systemic concomitant diseases that may interfere with healing or with protocol evaluation parameters;
- Use of non-steroidal anti-inflammatory drugs (NSAIDs), analgesics, antiplatelets and anticoagulants in the week before treatment;
- Use of any other treatment or medication that, according to its pharmacological properties and in the opinion of the Investigator, can alter the perception of pain, started in the week before the screening visit;
- Use of narcotic agents, antineoplastics, immunosuppressants or of any other agent that may interfere with healing in the 4 weeks before the screening visit;
- Neurological or psychiatric diseases that may threaten the obtaining of informed consent or the adherence to investigation procedures;
- Ongoing neoplastic (including skin cancer) and/or immunodepressive diseases;
- Subjects with known allergy or hypersensitivity to at least one component of any of the investigational medical devices;
- Ongoing or scheduled during the study radiation, laser, ultrasound, chemical peels treatment in the target area;
- Known hypocoagulability state;
- History of drugs and/or alcohol abuse;
- Subjects unable to measure pain properly by means of a visual analogue scale (VAS);
- Subjects considered to be unsuitable to participate, in the investigators opinion, for any other reason;
- Planned relocation during the study, which would make follow-up visits impossible;
- Concomitant participation in other clinical investigations or participation in the evaluation of any investigational drugs/devices during 3 months before this investigation or previous participation in the same investigation or planned to receive other investigational products during the study .
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05252325
Start Date
February 1 2022
End Date
March 1 2023
Last Update
February 23 2022
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