Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds (NCT03050710) | Clinical Trial Compass
CompletedNot Applicable
Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds
Austria62 participantsStarted 2016-12-27
Plain-language summary
In this study, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® VOLUME 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
âś“. Male or female 18 years of age or older
âś“. Presence of two fully visible, approximately symmetrical nasolabial folds, with each of the folds scored 2-3 according to the 5-grade Nasolabial Folds Severity Rating Scale (NLF-SRS) as assessed by the investigator
âś“. Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation
âś“. Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation
âś“. Written signed and dated informed consent
Exclusion criteria
âś•. Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only)
âś•. History of mental disorders or emotional instability
âś•. History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine, or any amide-based anaesthetic
âś•. Presence of silicone implant or another non-absorbable substance (permanent fillers) in the nasolabial region
âś•. Facial surgery or implantation of dermal fillers, absorbable and nonabsorbable sutures (thread), laser therapy, dermoabrasion, or botulinum toxin application in the nasolabial region within previous 12 months, or chemical peeling within previous 3 months, or planning to undergo such procedures in the treatment area during the study