Post Market Study Evaluating Princess Filler Lidocaine for the Correction of Nasolabial Folds (NCT03611491) | Clinical Trial Compass
CompletedNot Applicable
Post Market Study Evaluating Princess Filler Lidocaine for the Correction of Nasolabial Folds
Austria60 participantsStarted 2017-09-20
Plain-language summary
In this study, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® FILLER Lidocaine and will return for follow-up assessments 2, 4, 24 and 36 weeks after the treatment. A Touch-up treatment may be done at Week 2, if deemed appropriate by the investigator
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female 18 years of age or older
✓. 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
✓. Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation
✓. Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation
✓. Written signed and dated informed consent
Exclusion criteria
✕. Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only)
✕. History of mental disorders or emotional instability
✕. History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine, or any amide-based anaesthetic
✕. Presence of silicone implant or another non-absorbable substance (permanent fillers) in the nasolabial region
✕. Facial surgery or implantation of dermal fillers, absorbable and non-absorbable sutures, laser therapy, dermabrasion, or botulinum toxin application in the nasolabial region within previous twelve months, or chemical peeling within previous three months, or planning to undergo such procedures in the treatment area during the study
✕
What they're measuring
1
Change From Baseline in Average Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Week 24
Timeframe: Baseline and Week 24
2
Proportion of Subjects With ≥1 Point Reduction in Nasolabial Folds-Severity Rating Scale (NLF-SRS) Grade Based on Investigator Assessment at Week 24