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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03050710
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Croma-Pharma GmbH

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nasolabial Fold, Hypoplastic Device: Princess® VOLUME Lidocaine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Princess® VOLUME Lidocaine for the correction of nasolabial folds
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Prospective, Open-label, Multicenter, Post-market Study Evaluating Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds
Actual Study Start Date : December 27, 2016
Actual Primary Completion Date : July 18, 2017
Actual Study Completion Date : February 10, 2018

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. NLF-SRS grade of nasolabial folds [ Time Frame: 24 weeks ]
    The average change versus baseline in the NLF-SRS grade of nasolabial folds at Week 24 as evaluated by the investigator

  2. NLF-SRS grade of nasolabial folds [ Time Frame: 24 weeks ]
    The proportion of subjects with the NLF-SRS grade reduced by ≥1 point versus baseline at Week 24


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050710


Locations
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Austria
Medical University Graz
Graz, Austria
MÄZ WIEN Medizinisch Ästhetisches Zentrum Wien
Wien, Austria
Ordination Dr. Rudolf Bartsch und Dr. Katrin Bartsch
Wien, Austria
Sponsors and Collaborators
Croma-Pharma GmbH
More Information
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Responsible Party: Croma-Pharma GmbH
ClinicalTrials.gov Identifier: NCT03050710    
Other Study ID Numbers: CPH-401-201258
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
 Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action