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Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess® VOLUME in Nasolabial Folds

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: NCT01798498
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : July 30, 2014
Sponsor:
Collaborator:
FGK Clinical Research GmbH
Information provided by (Responsible Party):
Croma-Pharma GmbH

Brief Summary:
The aim of this clinical trial is to evaluate the efficacy and safety of Princess® VOLUME for the correction of nasolabial folds.

Condition or disease Intervention/treatment Phase
Nasolabial Folds Device: Princess® VOLUME Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Uncontrolled, Multicenter Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess® VOLUME in Nasolabial Folds
Study Start Date : April 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Princess® VOLUME

Injection of Princess® VOLUME into the deep dermis or subcutis of both nasolabial folds.

A touch-up treatment may be performed at Day 14 if correction is not complete after the first injection.

The injected volumes will be estimated by the investigator and depend on the depth of the nasolabial folds

Device: Princess® VOLUME
Other Name: highly cross-linked, viscoelastic hyaluronic acid injectable gel implant




Primary Outcome Measures :
  1. Change in Modified Fitzpatrick Wrinkle Scale (MFWS) from Day 0 to Day 180 [ Time Frame: Day 180 ]

Secondary Outcome Measures :
  1. Change in Modified Fitzpatrick Wrinkle Scale (MFWS) from Day 0 to Days 30, 90, and 270 [ Time Frame: Days 30, 90, and 270 ]
  2. Improvement of at least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS) [ Time Frame: Days 30, 90, 180 and Day 270 ]
    Percentage of subjects with an improvement of at least 0.5 on the MFWS at Days 30, 90, 180 and Day 270

  3. Subject satisfaction [ Time Frame: Days 30, 90, 180, and 270 ]
    Subject satisfaction at Days 30, 90, 180, and 270

  4. Global Aesthetic Improvement [ Time Frame: Days 30, 90, 180, and 270 ]
    Global Aesthetic Improvement Scale (GAIS) at Days 30, 90, 180, and 270

  5. Adverse events [ Time Frame: Days 0, 14, 30, 90, 180, 270 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Major Inclusion Criteria:

  • Male or female subjects between 30 years and 65 years
  • Wrinkle score of at least 2 according to the Modified Fitzpatrick Wrinkle Scale (MFWS)

Major Exclusion Criteria:

  • For females: pregnancy, lactating, planned pregnancy or unwilling to use contraceptives
  • History of allergic reaction to hyaluronic acid products
  • Facial surgery or implantation of dermal fillers in the nasolabial region within the last 24 months
  • Skin of the nasolabial region affected by cosmetic treatments (e.g. laser therapy within the last 12 months, chemical peeling within the last 3 months, dermabrasion within the last 12 months, botulinum toxin within the last 12 months )
  • Connective tissue diseases
  • Diabetes mellitus or uncontrolled systemic diseases
  • Known human immune deficiency virus-positive individuals
  • Presence of silicone implant or another non-absorbable substance (permanent fillers) in the area of product application
  • Cutaneous lesions in the evaluated area
  • Tendency to keloid formation and/or hypertrophic scars
  • Autoimmune disease
  • History of allergies against cosmetic filling products and re-current herpes simplex
  • History of immune system degradation

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): NCT01798498


Locations
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Austria
Medical University Graz
Graz, Austria
Ordination
Wien, Austria
Sponsors and Collaborators
Croma-Pharma GmbH
FGK Clinical Research GmbH
Investigators
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Principal Investigator: Daisy Kopera, Prof. Dr. Department of Dermatology and Gerontology, Medical University Graz
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Responsible Party: Croma-Pharma GmbH
ClinicalTrials.gov Identifier: NCT01798498    
Other Study ID Numbers: PVN1
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents