Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds

Nasolabial Fold, Hypoplastic Clinical Trial

— VINO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03050710
• Other study ID #: CPH-401-201258
• Status: Completed
• Phase: N/A
• Start date: December 27, 2016
• Est. completion date: February 10, 2018

Study information

• Verified date: August 2018
• Source: Croma-Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 10, 2018
• Est. primary completion date: July 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nasolabial Fold, Hypoplastic

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz
Austria	MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien	Wien
Austria	Ordination Dr. Rudolf Bartsch und Dr. Katrin Bartsch	Wien

Sponsors (1)

Lead Sponsor	Collaborator
Croma-Pharma GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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