Aging Clinical Trial - Effectiveness & Safety of STYLAGE® M LIDOCAINE

Status Completed

Clinical Trial Summary

This clinical investigation is designed to compare the STYLAGE® M Lidocaïne to STYLAGE® M in terms of correction of nasolabial folds severity and pain felt by the subject, and to assess and compare the safety and effectiveness of both products. Subjects with moderate to severe nasolabial folds will receive both treatments in a split-face design at D0, and a touch-up will be done 14 days after if necessary. The subjects will be followed-up over a 12-month period after initial injection.

Clinical Trial Description

The study will be prospective, triple-blinded (Subject, Treating Investigator, and Blinded Live Evaluator),randomized,within-subjects (split-face),active-controlled, monocenter with blinded subjects and evaluators assessing the efficacy , safety and pain of STYLAGE® M Lidocaïne and STYLAGE® M in the treatment of nasolabial folds. Sixty five healthy subjects between the age of 30 and 65, with symetrical moderate to severe nasolabial folds with grade 3 or 4 on both sides on the Wrinkle Severity Rating Scale (WSRS) for nasolabial folds as assessed in live, who have given their informed consent and met all eligibility criteria, will be enrolled. STYLAGE® M Lidocaïne will be injected in one nasolabial fold (right or left according to the randomization list). STYLAGE® M will be injected in the contralateral nasolabial fold. A touch-up is possible if required 14 days after. Subjects will be followed up at 14 days, 3, 6 and 12 months timepoints. All the effectiveness and safety evaluations will be done by a Blinded Live Evaluator (BLE) who will be different from the Treating Investigators. Variation in severity score of nasolabial folds will be assessed in live by the BLE and retrospectively assessed on photographs (2D) by an Independent Photographic Reviewer using the validated 5-point Wrinkles Severity Rating Scale (WSRS) at each time point The subjects and the independent blinded evaluator will assess the overall aesthetic improvement level of the face, for each side independently, at each time point after treatment initiation The subjects will be asked to score the pain felt during injection, and 5, 15 and 30 minutes after injection on a Visual Analog Scale . ;

Study Design

Related Conditions & MeSH terms

Aging

Clinical Trial Details

NCT number	NCT05087732
Study type	Interventional
Source	Laboratoires Vivacy
Contact
Status	Completed
Phase	N/A
Start date	October 19, 2021
Completion date	November 24, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effectiveness and Safety of STYLAGE® M LIDOCAINE Versus STYLAGE® M in Filling Nasolabial Folds — MLIDOM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms