CPH-401-201258

About this trial

Last updated 7 years ago

Study ID

CPH-401-201258

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

18+ Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 8 years ago

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.

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

Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds