TEOSYAL RHA® 1 for Neck Lines, Perioral Lines and Smiling Lines

Launched by TEOXANE SA · Apr 26, 2022

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria (General):
• • 1. Healthy adults, 35 to 70 years old seeking an improvement of their aesthetic appearance and beautification of their skin in 3 areas: perioral lines, smiling lines and neck lines.
• • 2. Subjects having given their informed consent.
• • 3. Subjects having wrinkle severity ranked as mild to moderate neck lines (grade 2 or grade 3 on the NLDS)
• • Inclusion Criteria (Cohort) 4. Healthy adult having wrinkle severity in at least one of the two indications (50% for each of the following cohort): i. Moderate to severe perioral rhytids (grade 2 or grade 3 on the PR-SRS) ii. Moderate to severe smiling lines (grade 3 or grade 4 on the SLDS)
• Exclusion Criteria:
• • 1. Minor subjects
• • 2. Subjects who already had fillers and/or other skin quality treatment(s) in the 6 months preceding the study.
• • 3. Subjects undergoing or planning to undergo peeling treatment or laser/ultrasound-based treatment during the study or having had one of these treatments in the 6 months preceding the study.
• • 4. Subjects showing cutaneous disorders, inflammation or infection (acne, herpes, scars...) at the treatment site or near to this site.
• • 5. Subjects having a known hypersensibility to lidocaine and/or amide local anesthetic agents or hyaluronic acid, or with history of severe allergy or anaphylactic shock.
• • 6. Subjects with autoimmune or cardiac diseases and/or undergoing treatment for heart diseases (beta blockers).
• • 7. Subjects with hepatocellular insufficiency and/or undergoing treatment for liver disease.
• • 8. Subjects suffering from epilepsy or porphyria.
• • 9. Subjects with severe, ongoing and/or uncontrolled disease that may pose a health risk to the subject during the study and/or may have an impact on the study assessments.
• • 10. Subjects receiving or planning to receive high dose Vitamin E, aspirin, anti-inflammatories, or anti-coagulant during the week preceding each injection.
• • 11. Subjects receiving any long-term medical treatment or any treatment that, in the opinion of the clinical investigator, may interfere with test results or put the subject at undue risk.
• • 12. Subjects under guardianship/tutorship.
• • 13. Pregnant women or breastfeeding mother.
• • 14. Subjects participating to another research on human beings or being in an exclusion period for a previous study.