NCT05252325

Clinical Study on Hyaluronic Acid With Lidocaine for the Treatment of Moderate to Severe Nasolabial Folds

Prospective, Controlled, Randomized, Blinded Evaluator, Split-face Clinical Study to Evaluate the Efficacy and Safety of Hyaluronic Acid Hydrogel With Lidocaine Lidocaine for the Treatment of Moderate to Severe Nasolabial Folds

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Centro Medico Polispecialistico · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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, one (HAL: Hyaluronic Acid plus Lidocaine ) on the one side of the face, the other (HA: Hyaluronic Acid) on the other side, in randomized fashion.

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, one (HAL) on the one side of the face, the other (HA) on the other side, in randomized fashion. The products will be administered by the Investigator/Co-Investigator (Treating Investigator), while the evaluations will be done by a Co-Investigator not aware of the side type treatment (Blinded Evaluator). The investigational plan include a Visit 1, during which subjects will be screened for entry (inclusion/exclusion) criteria; eligible subjects will be treated with the medical devices and followed for the next hour for pain and safety evaluation. Visit 2, 3 and Visit 4 are schedule after 2 (± 2 days), 12 (± 10 days) e 24 (± 10 days) weeks for the assessment of safety and clinical efficacy. Subjects prematurely discontinued from the investigation after the treatment will perform an 'Early termination visit', in which procedures scheduled for Visit 4 (24 weeks, final visit) will be performed (whenever feasible). In case of premature discontinuation of the investigation, the Investigator will duly record the reason for premature withdrawal in the appropriate section of the case report form (CRF). Visit 4 (or the 'Early termination Visit') will represent the conclusion of subject's participation in the investigation. Adverse events will be recorded during the entire investigational period by investigator's assessment and subjects' spontaneous reporting. Vital signs (blood pressure and heart rate) will be measured at each visit in the investigational site

Conditions

• Nasolabial Folds

Interventions

Type	Name	Description
DEVICE	hyaluronic acid plus lidocaine	local injection for correction of nasolabials fold
DEVICE	hyaluronic acid without lidocaine	local injection for correction of nasolabial folds

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2022-02-23
• Last updated: 2022-02-23