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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

Tracking Information
First Submitted Date  ICMJE February 9, 2017
First Posted Date  ICMJE February 13, 2017
Last Update Posted Date August 10, 2018
Actual Study Start Date  ICMJE December 27, 2016
Actual Primary Completion Date July 18, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds
Official Title  ICMJE A Prospective, Open-label, Multicenter, Post-market Study Evaluating Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Nasolabial Fold, Hypoplastic
Intervention  ICMJE 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
Study Arms  ICMJE Princess® VOLUME Lidocaine
Intervention: Device: Princess® VOLUME Lidocaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 10, 2018
Actual Primary Completion Date July 18, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03050710
Other Study ID Numbers  ICMJE CPH-401-201258
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Croma-Pharma GmbH
Study Sponsor  ICMJE Croma-Pharma GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Croma-Pharma GmbH
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP