Clinical study of the safety and effectiveness of the use of two hyaluronic acid injectable products (MaiLi Precise® and MaiLi Define®) in the treatment of facial skin depressions of the mid-face
- 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.Skin and Connective Tissue Diseases
- Registration Number
- ISRCTN10761529
- Lead Sponsor
- Sinclair Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 68
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
11. Subject predisposed to keloids or hypertrophic scarring
12. Subject with a known bleeding disorder or is receiving medication that will likely increase the risk of bleeding during treatment
13. Subject with a known history of precancerous lesions/skin malignancies
14. Subject with hypersensitivity or with known allergy to: hyaluronic acid, lidocaine, amide-type local anaesthetics or to one of the components of the tested devices or antiseptic solution
15. Subject with a known history of severe allergy or anaphylactic shock
16. Any medication which may interfere, at the interpretation of the investigator, with the study objectives in term of efficacy and safety
17. Subject having received treatment with a laser or UV, dermabrasion, surgery, deep chemical peeling or any other procedure based on active dermal below the level of the eyes within the past 6 months
18. Subject having received within the past 12 months hyaluronic acid injections (not including this study) below the level of the eyes
19. Subject having received at any time permanent filler (e.g. polylactic acid, PMMA, silicone) below the level of the eyes
20. Subject having received at any time threading surgery
21. Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, thrombolytics or anticoagulants within one week prior to injection visit and 1 month after treatment
22. Subject having started or changed his/her oral contraceptive or any other hormonal treatment during 12 weeks prior to study entry
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method