Clinical study to evaluate the safety and effectiveness of the use of two hyaluronic acid injectable products (Perfectha® Derm Lidocaine and Perfectha® Deep Lidocaine) in the treatment of lips
- Conditions
- For Perfectha® Derm Lidocaine: very thin to thin lip volume and with lip contour somewhat well-defined to poorly definedfor Perfectha® Deep Lidocaine: thin to moderate lip volumeNot Applicable
- Registration Number
- ISRCTN72858148
- 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
3.1. For group 1: subject seeking treatment for lip volume and for lip contour redefinition
3.2. For group 2: subject seeking treatment for lip volume
4.1. For group 1: subject with very thin to thin lip volume (grade 1 to 2 for superior and/or inferior lip on the Rossi scale) and with lip contour somewhat well-defined to poorly defined (grade 2 or 3 on the Draelos vermilion border scale)
4.2. For group 2: subject with thin to moderate lip volume (grade 2 to 3 for superior and/or inferior lip on the Rossi scale)
5. Subject having given freely and expressly his/her informed consent and data privacy consent
6. 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
7. Subject willing and able to comply with study follow-up procedures and schedule
8. Subject affiliated with a health social security system
9. Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks prior to study entry and during the study
10. Subject willing to commit to having no further facial aesthetic treatments on the nose, lips, perioral lines and marionette lines 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 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 not eligible for scientific reasons at the interpretation of the investigator
8. Subject under epidemiologic surveillance/in quarantine linked to the COVID-19 pandemic
9. Subject having a medical history which may interfere, at the interpretation of the investigator, with the study objectives in terms of effectiveness and safety
10. 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
11. Subject with a known history of or suffering from autoimmune disease and/or immune deficiency
12. Subject with uncontrolled epilepsy
13. Subject with porphyria
14. Subject with a known history of streptococcal disease (recurrent throat infections, acute rheumatic fever with or without cardiac involvement)
15. Subject suffering from active disease such as inflammation, infection, tumours, inflammatory and/or infectious cutaneous disorders (recurrent herpes, acne, rosacea) on or around the lips within 6 months of the study entry
16. Subject predisposed to keloids or hypertrophic scarring
17. Subject with known bleeding/clotting disorder or is receiving medication that will likely increase the risk of bleeding during treatment (taking thrombolytics, anticoagulants, aspirin, non-steroidal anti-inflammatory drugs or vitamin C) during 10 days before each injection
18. Subject with a known history of precancerous lesions/skin malignancies on/around the lips
19. Subject with hypersensitivity or with known allergy to hyaluronic acid, lidocaine, local disinfectant containing quaternary ammonium salts, amide-type local anaesthetics, avian proteins, feathers and egg or to one of the antiseptic solution
20. Subject with a known history of severe allergy or anaphylactic shock
21. Subject having received any medication which may interfere, at the interpretation of the investigator, with the study objectives in terms of effectiveness and safety
22. Subject receiving medical treatment that reduces or inhibits liver metabolism (cimetidine, beta-blockers)
23. Subject having received treatment with a laser or UV, dermabrasion, deep chemical peel, prolonged sun exposure or any other procedure based on active dermal response on/around the lips within the past 6 months
24. Subject having received surgery anywhere on the face within the past 6 months (12 months of washout are required for the cervicofacial lifting)
25. Subject having received within the past 12 months any hyaluronic acid filler
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Aesthetic improvement is measured using the Global Aesthetic Improvement Scale (GAIS) evaluated by an independent live assessor 3 months after treatment (M3)
- Secondary Outcome Measures
Name Time Method