Clinical study for the safety and effectiveness of the use of Perfectha® Derm lidocaine in the treatment of medium lines and depressions

Sinclair Pharma0 sites70 target enrollmentNovember 9, 2022

Overview

No summary available.

Registry

who.int

Start Date

November 9, 2022

End Date

November 8, 2023

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Sinclair Pharma

•1\. Sex: female or male
•2\. Age between 25 and 65 years
•3\. Subject seeking an improvement of her/his face aspect with a hyaluronic acid filler product
•4\. Subject presenting mild to medium lines and depressions such as:
•4\.1\. Mild to moderate NLFs (score 2 or 3 on both sides of the face \[identical score on both sides required] on the Wrinkle Severity Rating Scale \[WSRS]) as assessed live by the independent investigator
•4\.2\. Shallow to moderate marionette lines (score 1 or 2 on both sides of the face \[identical score on both sides required] on the Marionette Lines Grading Scale \[MLGS]) as assessed live by the independent investigator
•5\. The extent(s) of the subject’s nasolabial folds or marionette lines is/are sufficient that it is possible to achieve at least a 1\-point improvement on the WSRS or MLGS scale with study intervention based on the judgement of the live independent investigator
•6\. Subject having given freely and expressly his/her informed consent and data privacy consent
•7\. Subject affiliated with a health social security system
•8\. Subject willing to have photographs of the face taken and who are willing to provide approval for the use of their study data and anonymized photographs in published literature

•1\. Pregnant or nursing woman or planning a pregnancy during the study
•2\. Subject who has been deprived of their freedom by administrative or legal decision or who is under guardianship
•3\. Subject in a social or sanitary establishment
•4\. Subject is an employee of the investigational site, the CRO or the study sponsor
•5\. Subject with scar(s), mole(s) or anything on the studied zones which might interfere with the evaluation (tattoo, permanent make\-up)
•6\. Subject with major dental problems or major dental procedure within 6 weeks before screening visit or planned during the study
•7\. Subject under epidemiologic surveillance or in quarantine linked to the COVID\-19 pandemic
•8\. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study result and/or subject safety
•9\. Subject with a known history of or suffering from autoimmune disease and/or immune deficiency
•10\. Subject with uncontrolled epilepsy