Post Market Study Evaluating Princess Filler Lidocaine for the Correction of Nasolabial Folds
Sponsored by Croma-Pharma GmbH
About this trial
Last updated 6 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 7 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
1. Male or female 18 years of age or older 2. Presence of two fully visible, approximately symmetrical nasolabial folds, with each of the folds scored 2-3 according to the 5-grade NLF-SRS as assessed by the investigator 3. Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation 4. Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation 5. Written signed and dated informed consent
Exclusion Criteria
Subjects meeting any of the following criteria should not be enrolled: 1. Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only) 2. History of mental disorders or emotional instability 3. History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine, or any amide-based anaesthetic 4. Presence of silicone implant or another non-absorbable substance (permanent fillers) in the nasolabial region 5. Facial surgery or implantation of dermal fillers, absorbable and non-absorbable sutures, laser therapy, dermoabrasion, or botulinum toxin application in the nasolabial region within previous twelvemonths, or chemical peeling within previous three months, or planning to undergo such procedures in the treatment area during the study 6. Presence of infectious, inflammatory, or proliferative lesions in the nasolabial region 7. Cutaneous lesions in the treatment area 8. Known human immune deficiency virus-positive individuals 9. History of allergies against aesthetic filling products and recurrent herpes simplex 10. Tendency to hypertrophic scars, keloid formation and/or pigmentation disorders 11. History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy 12. Diabetes mellitus or uncontrolled systemic diseases 13. Use of anticoagulant, antiplatelet or thrombolytic medication from ten days pre- to three days post injection 14. Any medical condition which, in the investigator's opinion, prohibits the inclusion in the study 15. Current or previous (within 30 days of enrolment) treatment with another investigational drug and/or medical device or participation in another clinical study 16. Previous enrolment in this clinical investigation 17. Subjects whose participation in clinical trials is prohibited by the Austrian Medical Devices Act (e.g., persons with a legal custodian appointed due to mental disability, prisoners, soldiers and other members of the armed forces, civil servants)