Clinical study of the safety and effectiveness of MaiLi Precise® and MaiLi Define® in the treatment of facial skin depressions

Sinclair Pharma0 sites68 target enrollmentFebruary 16, 2022

Overview

Phase: 未知
Intervention: Not specified
Conditions: For MaiLi Precise® treatment: mild to moderate nasolabial folds and/or subjects with mild to moderate tear trough. For MaiLi Define® treatment: moderate to severe nasolabial folds and/or moderate to severe marionette lines.
Sponsor: Sinclair Pharma
Enrollment: 68
Status: Completed
Last Updated: last year

No summary available.

Registry

who.int

Start Date

February 16, 2022

End Date

July 30, 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 hyaluronic acid filler product
•4\.1\. For group 1: subject with mild to moderate nasolabial folds (score 2 to 3 on the Wrinkle Severity Rating Scale \[WSRS]) and/or subjects with mild to moderate tear trough (score 1 to 2 on the Barton scale)
•4\.2\. For group 2: subject with moderate to severe nasolabial folds (score 3 to 4 on the WSRS scale) and/or subjects with moderate to severe marionette lines (score 2 and 3 on the Marionette Lines Grading Scale (MLGS)
•5\. Subject having given freely and expressly his/her informed consent
•6\. Subject willing to have photographs of the face taken and who are willing provide approval for the use of their study data and photographs in published literature
•7\. Subject willing and able to comply with study follow\-up procedures and schedule
•8\. Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks prior to study entry and during all the study
•9\. Subjects willing to commit to having no further facial aesthetic treatments below the level of the eyes for the duration of the study period, including follow\-up

•1\. Pregnant or nursing woman or planning a pregnancy during the study
•2\. Subject in a social or sanitary establishment
•3\. Subject suspected to be non\-compliant according to the investigator’s judgment
•4\. Subject is an employee of the investigational site, the CRO or study sponsor
•5\. Subject with scar(s), mole(s) or anything on the studied zones which might interfere with the evaluation
•6\. 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
•7\. Subject with a known history of or suffering from autoimmune disease and/or immune deficiency
•8\. Subject with porphyria
•9\. Subject with a known history of streptococcal disease (recurrent throat infections, acute rheumatic fever with or without cardiac involvement)
•10\. Subject suffering from active disease such as inflammation, infection, tumours, inflammatory and/or infectious cutaneous disorders (herpes, acne, rosacea) on the face within 6 months of the study entry