Clinical study of the safety and effectiveness of two hyaluronic acid injectable products (MaiLi Precise® and MaiLi Define®) as fillers in the treatment of lip thinness and wrinkles around the mouth
- Conditions
- For MaiLi Precise® treatment: very thin to thin lip volume and /or moderate to severe perioral wrinklesfor MaiLi Define® treatment: thin to moderate lip volumeNot Applicable
- Registration Number
- ISRCTN30768206
- Lead Sponsor
- Sinclair Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 68
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
10. Subject willing to commit to having no further facial aesthetic treatments below the zygomatic arch for the duration of the study period, including follow-up
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
11. Subject with porphyria
12. Subject with a known history of streptococcal disease (recurrent throat infections, acute rheumatic fever with or without cardiac involvement)
13. Subject suffering from active disease such as inflammation, infection, tumours, inflammatory and/or infectious cutaneous disorders (herpes, acne, rosacea) on or around the lips within 6 months of the study entry
14. Subject predisposed to keloids or hypertrophic scarring
15. Subject with a known bleeding disorder or is receiving medication that will likely increase the risk of bleeding during treatment
16. Subject with a known history of precancerous lesions/skin malignancies
17. 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
18. Subject with a known history of severe allergy or anaphylactic shock
19. Subject having received any medication which may interfere, at the interpretation of the investigator, with the study objectives in terms of efficacy and safety
20. Subject having received treatment with a laser or UV, dermabrasion, surgery, deep chemical peeling or any other procedure based on active dermal response on/around the lips within the past 6 months
21. Subject received within the past 12 months hyaluronic acid injections (not including this study) on or around the lips
22. Subject received at any time permanent filler (e.g. polylactic acid, PMMA, silicone) on or around the lips
23. Subject received at any time a lip threading surgery
24. Subject received oral surgery (e.g. tooth extraction, orthodontia or implantation) within 6 weeks prior to study entry
25. 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
26. 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
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method