This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

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

CPH-401-201324

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Trial Timing

Ended 7 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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

No

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)

Locations

Location

Status