Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles
- Conditions
- Nasolabial Fold
- Registration Number
- NCT06471933
- Lead Sponsor
- Nordberg Medical AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Signed Informed Consent Form<br><br> - Male or female, =18 years old.<br><br> - Immune-competent individuals.<br><br> - Presenting NLF contour deficiencies with a WSRS score between 2 (shallow wrinkle)<br> and 4 (deep wrinkle) on both the left and right side of the face.<br><br>Exclusion Criteria:<br><br> - Having received a prior facial surgery for NLF correction, and/or received any local<br> therapeutic treatment (e.g., dermal fillers).<br><br> - Having received in the past 2 weeks any local therapeutic treatment of the face<br> below zygomatic arch.<br><br> - Pigmentation in NLF or having a history of hypo melanosis.<br><br> - Susceptibility to keloid formation or hypertrophic scarring.<br><br> - History of a known allergic reaction (e.g., any subject allergic to lidocaine or<br> amide anesthetics, has a history of allergy to Gram-positive bacterial protein, or<br> known to be allergic to any of the constituents of the product: PLLA, sodium<br> carboxymethyl cellulose, mannitol, or sodium hyaluronate).<br><br> - History of herpes eruption, or a history of malignant skin disorder, or a history of<br> any other serious disease.<br><br> - Hemorrhagic disease or receiving anti-coagulant therapy.<br><br> - Presenting with acute inflammation, infection, or having a history of chronic or<br> recurrent infection potentially affecting the safety or performance of the device or<br> increasing risk for adverse events.<br><br> - Having received in the past 2 months immunosuppressant or systemic steroid therapy.<br><br> - Having any disease that may affect wound healing, such as connective tissue disorder<br> or serious malnutrition.<br><br> - Female who is pregnant and/or lactating<br><br> - Any other condition that as judged by the investigator may make follow-up or<br> Investigation procedures inappropriate
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement on Wrinkle Severity Rating Scale (WSRS) of at least 1 grade.
- Secondary Outcome Measures
Name Time Method Percentage of subjects with improvement of at least 1 grade on the WSRS.;Change in WSRS score;Mean WSRS of <2 at each follow-up time;Time to at least one grade improvement in mean WSRS and time to mean WSRS <2.;Change Face-Q score of Nasolabial Fold;Change in Global Aesthetic in Improvement Scale;Subject Satisfaction Scores