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

NCT05087732 | Completed

• 1 other identifier: VIV-STYL-LIDO-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging

Keywords

hyaluronic acid; Nasolabial Folds; Injection; Healthy subjects; Prospective; Randomized; Pain; Within-subjects

Outcome Measures

Primary Outcomes (2)

• Difference of aesthetic improvement on the Wrinkle Severity Rating Scale (WSRS),

  First co-primary endpoint will be the difference of aesthetic improvement on the Wrinkle Severity Rating Scale (WSRS), as evaluated by the BLE, at the side of the face treated with Stylage® M lidocaïne compared to the side of the face treated with Stylage® M, in a double non-inferiority statistical model.

  6 months

• Within-subject difference in injection site pain

  Second co-primary endpoint will be the (STYLAGE® M Side - STYLAGE® M lidocaine Side), self-assessed by the subjects on a 100 mm Visual Analogue Scale (VAS), in a superiority statistical model.

  immediatly after injection of each side

Secondary Outcomes (14)

• WSRS change from baseline

  4 days, 3, and 12 months after baseline

• WSRS change from baseline on photographs

  14 days, 3, 6, and 12 months after baseline

• Responder rate for WSRS in live

  14 days, 3, 6, and 12 months after baseline

• Responder rate for WSRS on photograph

  14 days, 3, 6 and 12 months after baseline

• Global Aesthetic Improvement assessed by the BLE

  14 days, 3, 6, and 12 months after baseline

Study Arms (2)

Stylage® M Lidocaïne

EXPERIMENTAL

STYLAGE® M Lidocaine is a hyalorunic acid injectable gel with Lidocaine hydrochloride whose intended purpose is the filling of skin depressions on the face by dermal injection.

Device: STYLAGE® M Lidocaïne; Device: STYLAGE® M

Stylage® M

ACTIVE COMPARATOR

STYLAGE® M Lidocaine is a hyalorunic acid injectable gel whose intended purpose is the filling of skin depressions on the face by dermal injection.

Device: STYLAGE® M Lidocaïne; Device: STYLAGE® M

Interventions

STYLAGE® M Lidocaïne DEVICE

Up to 2 mL will be injected at Day 0 on a nasolabial fold and, if required, up to 1 mL could be injected 14 days after on the same nasolabial fold (touch-up).

Stylage® M; Stylage® M Lidocaïne

STYLAGE® M DEVICE

Up to 2 mL will be injected at Day 0 on a nasolabial fold and, if required, up to 1 mL could be injected 14 days after on the same nasolabial fold (touch-up).

Stylage® M; Stylage® M Lidocaïne

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subject.
• Age: between 30 and 65 years.
• Subject with right and left NLF rating grade 3 or 4 (Moderate or Severe) on the Wrinkle Severity Rating Scale (WSRS), as assessed by a Blinded Live Evaluator.
• Subject having the same WSRS grade on both NLFs (i.e., symmetrical NLFs).
• Subject with marionette's lines that do not require to be treated in addition to nasolabial folds, according to the Blinded Live Evaluator.
• Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures (i.e., dermal fillers, toxin treatments, facial ablative or fractional laser, microdermal abrasion, chemical peels, non-invasive skin-tightening) below the level of the lower orbital rim, for the duration of the study.
• Subjects agreeing not to take Anti-histamines within 2 weeks prior to touch-up visit
• Subject able to comply with protocol requirements and to complete all required visits.
• Subject, psychologically able to understand the study related information and to give a written informed consent.
• Subject having given freely and expressly his/her informed consent to participate in the study, and use of data privacy, prior to any study-related procedure being performed.
• Subject agreeing to have photographs taken.
• Female of childbearing potential must have a negative urinary pregnancy test (UPT) at Visit 1 and practice a reliable method of contraception throughout the study, and for at least 12 weeks prior to study enrolment.
• Subject affiliated to a health social security.

You may not qualify if:

• Subject presenting any symptom which can be related to a medical condition that is likely to make the subject not being compliant with the study schedule, at the discretion of the investigator
• Pregnant or breastfeeding woman or planning a pregnancy during the study.
• Had prior surgery in the mid- and/or lower-face area, including the nasolabial fold(s), or has a permanent implant or graft in the mid- and/or lower-face area, or a tattoo, a scar, moles, or anything that could interfere with effectiveness assessments. (NOTE: Rhinoplasty is permitted if the procedure was ≥ 12 months prior to study enrolment).
• Subject in a social or sanitary establishment.
• Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
• Subject having received 4500 euros indemnities for participation in researches involving human beings in France in the 12 previous months, including participation in the present study.
• Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.
• Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
• Subject with a past history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats with cardiac localisation.
• Subjects suffering from porphyria.
• Subject having history of severe allergy or anaphylactic shock including hypersensitivity to hyaluronic acid, to gram positive bacterial proteins, to lidocaine or antiseptic solution or amide type local anaesthetics.
• Subject predisposed to develop keloids or hypertrophic scarring.
• Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.
• Subject having received treatment with a laser, a dermabrasion, a surgery, a peeling or other ablative procedure below the inferior orbital rim within the past 6 months prior to study start.
• Subject having received injection with a resorbable filling product (eg, hyaluronic acid, collagen) below the inferior orbital rim within the past 12 months prior to study start.

Sponsors & Collaborators

• Laboratoires Vivacy: lead

Study Sites (1)

Eurofins Dermscan Pharmascan

Villeurbanne, 69100, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Siham RHARBAOUI

  Dermscan Pharmascan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treating investigators (Injectors) , subjects, blinded live evaluator and Independant Photographic reviewer are blinded. The product name will not be printed on the labels of investigational device (outside boxes, blisters and syringes )
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Within-subject study with treatment of one nasolabial fold with STYLAGE® M and STYLAGE® M Lidocaïne of the other nasolabial fold

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 21, 2021
• Study Start: October 19, 2021
• Primary Completion: May 18, 2022
• Study Completion: November 24, 2022
• Last Updated: December 2, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)