Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds

Not Applicable

Completed

• Conditions: Nasolabial Fold, Hypoplastic
• Interventions: Device: Princess® VOLUME Lidocaine

• Registration Number: NCT03050710
• Lead Sponsor: Croma-Pharma GmbH

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-27
• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-13
• Primary Completion: 2017-07-18
• Study Completion: 2018-02-10
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Princess® VOLUME Lidocaine	Princess® VOLUME Lidocaine	-

Primary Outcome Measures

Name	Time	Method
NLF-SRS grade of nasolabial folds	24 weeks	The proportion of subjects with the NLF-SRS grade reduced by ≥1 point versus baseline at Week 24

Trial Locations

Locations (3)

Medical University Graz; 🇦🇹 Graz, Austria

MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien; 🇦🇹 Wien, Austria

Ordination Dr. Rudolf Bartsch und Dr. Katrin Bartsch; 🇦🇹 Wien, Austria