Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds (VINO)

Croma-Pharma

Status

Completed

Conditions

Nasolabial Fold, Hypoplastic

Treatments

Device: Princess® VOLUME Lidocaine

Study type

Interventional

Funder types

Industry

Identifiers

NCT03050710

CPH-401-201258

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 Nasolabial Folds Severity Rating Scale
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 allergic reaction or hypersensitivity to hyaluronic acid, lidocaine, or any amide-based anesthetic
Presence of silicone implant or another non-absorbable substance (permanent fillers) in the nasolabial region
Presence of infectious, inflammatory, or proliferative lesions in the nasolabial region
Cutaneous lesions in the treatment area
History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy
Use of anticoagulant, antiplatelet or thrombolytic medication
Any medical condition which, in the investigator's opinion, prohibits the inclusion in the study