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

Launched by LABORATOIRES VIVACY · Oct 12, 2021

Keywords

ClinConnect Summary

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 consen...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy subject.
• • 2. Age: between 30 and 65 years.
• • 3. 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.
• • 4. Subject having the same WSRS grade on both NLFs (i.e., symmetrical NLFs).
• • 5. Subject with marionette's lines that do not require to be treated in addition to nasolabial folds, according to the Blinded Live Evaluator.
• • 6. 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.
• • 7. Subjects agreeing not to take Anti-histamines within 2 weeks prior to touch-up visit
• • 8. Subject able to comply with protocol requirements and to complete all required visits.
• • 9. Subject, psychologically able to understand the study related information and to give a written informed consent.
• • 10. 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.
• • 11. Subject agreeing to have photographs taken.
• • 12. 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.
• • 13. Subject affiliated to a health social security.
• Exclusion Criteria:
• • 1. 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
• • 2. Pregnant or breastfeeding woman or planning a pregnancy during the study.
• • 3. 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).
• • 4. Subject in a social or sanitary establishment.
• • 5. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
• • 6. Subject participating to another research on human beings or who is in an exclusion period of one.
• • 7. 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.
• • 8. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.
• • 9. Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
• • 10. Subject with a past history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats with cardiac localisation.
• • 11. Subjects suffering from porphyria.
• • 12. 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 inclusion.
• • 13. 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.
• • 14. Subject predisposed to develop keloids or hypertrophic scarring.
• • 15. Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.
• • 16. 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.
• • 17. 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.
• • 18. Subject having received at any time injection with a slowly resorbable filling product (polylactic acid, calcium hydroxyapatite, combinations of hyaluronic acid (HA) and hypromellose, HA and dextran microbeads or HA and TriCalcium Phosphate (TCP), etc.) or with a non-resorbable filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles, etc.).
• • 19. Subject having received at any time a treatment with tensor threads below the inferior orbital rim.
• • 20. Subject who received oral surgery (tooth extraction, orthodontia or implantation) within 6 weeks prior to study start or who plans to undergo any of these procedures during the study.
• • 21. Subject having started or changed her oral contraceptive or any other hormonal treatment during 12 weeks prior to study start or planning to change it during the study.
• • 22. Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAID) (ibuprofen, naproxen, etc.), antiplatelet agents, anticoagulants, vitamin C or other substances known to increase coagulation time within one week prior to treatment dates.
• • 23. Subject using medication that reduce or inhibit hepatic metabolism (cimetidine, beta-blockers, etc.).
• 24. Subject undergoing a topical treatment on the test area or a systemic treatment:
• • Anti-histamines during the 2 weeks prior to study start;
• • Immunosuppressors and/or corticoids during the 4 weeks prior to study start;
• • Retinoids during the 6 months prior to study start.