Effectiveness and Safety of STYLAGE® L Lidocaïne in the Treatment of Nasolabial Folds

NCT04844216 | Completed

• 1 other identifier: 2020-A03409-30
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 2

Brief Summary

STYLAGE® L Lidocaine is a CE-marked hyaluronic acid gel intended to fill skin depressions on the face by dermal injection. In this study, 50 healthy subjects between the age of 30 and 65, with moderate to severe nasolabial folds as assessed in live, who have given their informed consent and met all eligibility criteria, will be enrolled. Subjects will randomly receive injection of STYLAGE® L Lidocaine on one nasolabial fold and injection of an active comparator on the other nasolabial fold. A touch-up is possible if required one month after. Subjects will come to a total of 7 visits over a period of 12 months. Variation in severity score of nasolabial folds will be assessed in live and on photographs by independent evaluators. Variation in nasolabial fold depth, global aesthetic improvement, subject satisfaction, pain at injection site and safety will also be assessed.

Conditions

Aging

Keywords

Aging; Hyaluronic acid; Nasolabial fold; Injection; Healthy subjects; Independent evaluators; Prospective; Randomized study; Within-subject; Controlled; Multicenter

Outcome Measures

Primary Outcomes (1)

• Mean change in nasolabial fold severity assessed in live

  Mean change in nasolabial fold severity from baseline to 6 months after treatment initiation, as assessed by an independent blinded live evaluator using the validated 5-point Wrinkles Severity Rating Scale (WSRS). The Wrinkles Severity Rating Scale is a 5-grade scale (from grade 1 to grade 5) with minimum grade representing a better outcome. Grade 1 corresponds to "Absent", grade 2 to "Mild", grade 3 to "Moderate", grade 4 to "Severe" and grade 5 to "Extreme".

  Month 6

Secondary Outcomes (9)

• Mean change in nasolabial fold severity assessed in live

  Month 1, Month 3, Month 9, Month 12

• Mean change in nasolabial fold severity assessed on photographs

  Month 1, Month 3, Month 6, Month 9, Month 12

• Evaluation of WSRS responder rate

  Month 1, Month 3, Month 6, Month 9, Month 12

• Evaluation of global aesthetic improvement

  Month 1, Month 3, Month 6, Month 9, Month 12

• Evaluation of GAIS responder rate

  Month 1, Month 3, Month 6, Month 9, Month 12

Study Arms (2)

Nasolabial fold treated with experimental device

EXPERIMENTAL

STYLAGE® L Lidocaine is a hyalorunic acid injectable gel whose intended purpose is the filling of skin depressions on the face by dermal injection. Up to 2 mL will be injected at Day 0 on a nasolabial fold and, if required, up to 1 mL could be injected 1 month after on the same nasolabial fold (touch-up).

Device: STYLAGE® L Lidocaine

Nasolabial fold treated with comparator

ACTIVE COMPARATOR

The active comparator is a hyalorunic acid injectable gel whose intended purpose is the filling of mid and/or deep depressions of the skin via mid and/or deep dermal injection. Up to 2 mL will be injected at Day 0 on a nasolabial fold and, if required, up to 1 mL could be injected 1 month after on the same nasolabial fold (touch-up).

Device: Active control

Interventions

STYLAGE® L Lidocaine DEVICE

An injection of maximum 2 mL on one nasolabial fold is planned at Day 0. A touch-up of maximum 1 mL on the same nasolabial fold is possible 1 month after D0 (month 1).

Also known as: Injection of hyaluronic acid gel

Nasolabial fold treated with experimental device

Active control DEVICE

An injection of maximum 2 mL on one nasolabial fold is planned at Day 0. A touch-up of maximum 1 mL on the same nasolabial fold is possible 1 month after D0 (month 1).

Also known as: Injection of hyaluronic acid gel

Nasolabial fold treated with comparator

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.
• Sex: female or male.
• Age: between 30 and 65 years.
• Subject having given freely and expressly his/her informed consent and data privacy consent.
• Subject with approximate symmetry, moderate to severe Nasolabial Folds (NLFs) attaining either grade 3 on both sides or grade 4 on both sides on the Wrinkle Severity Rating Scale (WSRS) for NLF, as assessed in live.
• Subject with marionette's lines that do not require to be treated according to investigator.
• Subject willing to have photographs of the face taken.
• Subject, psychologically able to understand the study related information and to give a written informed consent.
• Subject agreeing not to receive another aesthetic procedure on the face (e.g., laser, dermabrasion, surgery, deep chemical peeling, surface peel, tensor threads, injection with a filling product) during the whole study.
• Subject affiliated to a health social security system.
• Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before screening visit and during the whole study.

You may not qualify if:

• Pregnant or breastfeeding woman or planning a pregnancy during the study.
• Subject with a tattoo, a scar, moles or anything on the studied zones which might interfere with the evaluation.
• Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
• Subject in a social or sanitary establishment.
• For France only: 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 suffering from untreated epilepsy.
• 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 and in case of acute rheumatic fever with heart complications.
• Subjects suffering from porphyria.
• Subject suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma…). Subject with recurrent herpes is not eligible even if asymptomatic at time of screening visit.
• Subject having history of allergy or anaphylactic shock including hypersensitivity to hyaluronic acid, to gram positive bacterial proteins, to lidocaine, to one of the components of the tested devices or antiseptic solution or amide-type local anaesthetics.
• Subject having history of severe and/or evolutive / unstable / recent allergy.
• Subject predisposed to develop keloids or hypertrophic scarring.
• Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.

Sponsors & Collaborators

• Laboratoires Vivacy: lead

Study Sites (2)

Eurofins Dermscan Pharmascan

Villeurbanne, 69100, France

Location

Eurofins Dermscan Poland

Gdansk, 80-288, Poland

Location

Study Officials

• Sophie CONVERSET-VIETHEL, MD

  Cabinet de chirugie de la face et du cou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Injectors will be unblinded. All subjects, investigators (in charge of clinical examination, assessment of local tolerance, live and on photograph assessment of nasolabial folds severity), as well as technicians (in charge of photographs and measurement of roughness) will be blinded.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Within-subject study with treatment of one nasolabial fold with the investigational medical device and treatment of the other nasolabial fold with a comparator (another medical device).

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 14, 2021
• Study Start: April 16, 2021
• Primary Completion: January 13, 2022
• Study Completion: July 6, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); PL (1)