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

A Prospective, Open-label, Multicenter, Post-market Study Evaluating Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds

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.

Study Overview

• Status: Completed
• Conditions: Nasolabial Fold, Hypoplastic
• Intervention / Treatment: Device: Princess® VOLUME Lidocaine

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Medical University Graz
  • Wien, Austria
    • MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien
  • Wien, Austria
    • Ordination Dr. Rudolf Bartsch und Dr. Katrin Bartsch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Princess® VOLUME Lidocaine	Device: Princess® VOLUME Lidocaine; Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NLF-SRS grade of nasolabial folds	The average change versus baseline in the NLF-SRS grade of nasolabial folds at Week 24 as evaluated by the investigator	24 weeks
NLF-SRS grade of nasolabial folds	The proportion of subjects with the NLF-SRS grade reduced by ≥1 point versus baseline at Week 24	24 weeks

Collaborators and Investigators

• Sponsor: Croma-Pharma GmbH

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2016
• Primary Completion (Actual): July 18, 2017
• Study Completion (Actual): February 10, 2018

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 13, 2017

Study Record Updates

• Last Update Posted (Actual): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: CPH-401-201258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No