ISRCTN30768206
Active, not recruiting
未知
Clinical study of the safety and effectiveness of the use of MaiLi Precise® and MaiLi Define® in the treatment of lips and perioral area
Sinclair Pharma0 sites68 target enrollmentMarch 29, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sinclair Pharma
- Enrollment
- 68
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Sex: female or male
- •2\. Age: between 18 and 65 years
- •3\. Subject seeking an improvement of her/his lip volume and/or perioral area
- •4\.1\. For group 1: subject with very thin to thin lips volume (score 1 to 2 on Rossi scale) and /or subject with moderate to severe perioral wrinkles (score 2 to 6 on the Bazin scale)
- •4\.2\. For group 2: subject with thin to moderate lips volume (score 2 to 3 on Rossi scale)
- •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\. Subject affiliated to a health social security system
- •9\. Females of childbearing potential should use a medically accepted contraceptive regimen for at least 12 weeks prior to study entry and during the study
Exclusion Criteria
- •1\. Pregnant or nursing woman or planning a pregnancy during the study
- •2\. Subject who had 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 suspected to be non\-compliant according to the investigator’s judgment
- •5\. Subject is an employee of the investigational site, the CRO or the study sponsor
- •6\. Subject with scar(s), mole(s) or anything on the studied zones which might interfere with the evaluation (tattoo, permanent make\-up)
- •7\. Subject with major dental problems
- •8\. Subject under epidemiologic surveillance / in quarantine linked to the COVID\-19 pandemic
- •9\. 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
- •10\. Subject with a known history of or suffering from autoimmune disease and/or immune deficiency
Outcomes
Primary Outcomes
Not specified
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