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

Open-label Uncontrolled, Multicenter Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess® VOLUME in Nasolabial Folds

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

Study Overview

• Status: Completed
• Conditions: Nasolabial Folds
• Intervention / Treatment: Device: Princess® VOLUME

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Medical University Graz
  • Wien, Austria
    • Ordination 1
  • Wien, Austria
    • Ordination 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: highly cross-linked, viscoelastic hyaluronic acid injectable gel implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Day 180	The primary efficacy endpoint was the absolute change in MFWS from Day 0 to Day 180 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments. The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle; Fine wrinkle: visible wrinkle and slight indentation 1.5 Visible wrinkle and clear indentation, <1 mm wrinkle depth; Moderate wrinkle: clear visible wrinkle 1 - 2 mm wrinkle 2.5 Prominent and visible wrinkle: more than 2 mm and less than 3 mm wrinkle depth; Deep wrinkle: deep and furrow wrinkle; more than 3 mm wrinkle depth	From Day 0 to Day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Days 30, 90, and 270	The change in absolute Modified Fitzpatrick Wrinkle Scale (MFWS) from Day 0 was additionally assessed at Days 30, 90, and 270 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle; Fine wrinkle: visible wrinkle and slight indentation 1.5 Visible wrinkle and clear indentation, <1 mm wrinkle depth; Moderate wrinkle: clear visible wrinkle 1 - 2 mm wrinkle 2.5 Prominent and visible wrinkle: more than 2 mm and less than 3 mm wrinkle depth; Deep wrinkle: deep and furrow wrinkle; more than 3 mm wrinkle depth	Day 0 to Days 30, 90, and 270
Percentage of Subjects With an Improvement of at Least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS)	Percentage of subjects with an improvement of at least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS) at Days 30, 90, 180, and 270 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle; Fine wrinkle: visible wrinkle and slight indentation 1.5 Visible wrinkle and clear indentation, <1 mm wrinkle depth; Moderate wrinkle: clear visible wrinkle 1 - 2 mm wrinkle 2.5 Prominent and visible wrinkle: more than 2 mm and less than 3 mm wrinkle depth; Deep wrinkle: deep and furrow wrinkle; more than 3 mm wrinkle depth	Days 30, 90, 180, and 270
Subject Satisfaction	Subject satisfaction at Days 30, 90, 180, and 270 To assess subject's satisfaction, subjects were asked to indicate their level of satisfaction on 3- or 5-point scales as follows: Question 1: How would you judge the change of your appearance after treatment (asked at Days 30, 90, 180, and 270):Very much improvedMuch improvedSlightly improvedNo changeWorsened; Question 2: How satisfied are you with the treatment (to be asked at Days 30 and 270):Very satisfiedSatisfiedNot satisfied; Question 3: Would you recommend the treatment to your friends and acquaintances (to be asked at Days 30 and 270):YesPerhapsNo	Days 30, 90, 180, and 270
Global Aesthetic Improvement Scale (GAIS)	Investigator rating of aesthetic improvement based on GAIS The GAIS is a 5-point scale that rates global aesthetic improvement in appearance, compared to pre-treatment, as judged by the investigator. The rating categories were 'worse', 'no change', 'improved', 'much improved', and 'very much improved'.	Days 14, 30, 90, 180, 270

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day	Percentage of subjects with an improvement of at least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS) at Days 14, 30, 90, 180, and 270 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle; Fine wrinkle: visible wrinkle and slight indentation 1.5 Visible wrinkle and clear indentation, <1 mm wrinkle depth; Moderate wrinkle: clear visible wrinkle 1 - 2 mm wrinkle 2.5 Prominent and visible wrinkle: more than 2 mm and less than 3 mm wrinkle depth; Deep wrinkle: deep and furrow wrinkle; more than 3 mm wrinkle depth	Day 0 to Day 14, 30, 90, 180, and 270
Improvement in MFWS in One or Both Nasolabial Folds Over Time	Percentage of subjects with an improvement of at least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS) from Day 0 to Days 30, 90, 180, and 270 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments. The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle; Fine wrinkle: visible wrinkle and slight indentation 1.5 Visible wrinkle and clear indentation, <1 mm wrinkle depth; Moderate wrinkle: clear visible wrinkle 1 - 2 mm wrinkle 2.5 Prominent and visible wrinkle: more than 2 mm and less than 3 mm wrinkle depth; Deep wrinkle: deep and furrow wrinkle; more than 3 mm wrinkle depth	Day 0 to Day 30, 90, 180, and 270

Collaborators and Investigators

• Sponsor: Croma-Pharma GmbH
• Collaborators: FGK Clinical Research GmbH
• Investigators: Principal Investigator: Daisy Kopera, Prof. Dr., Department of Dermatology and Gerontology, Medical University Graz

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: February 22, 2013
• First Submitted That Met QC Criteria: February 22, 2013
• First Posted (Estimated): February 26, 2013

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immunologic Factors; Physiological Effects of Drugs; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: PVN1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No