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

July 29, 2014 updated by: Croma-Pharma GmbH

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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
Time Frame
Change in Modified Fitzpatrick Wrinkle Scale (MFWS) from Day 0 to Day 180
Time Frame: Day 180
Day 180

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Modified Fitzpatrick Wrinkle Scale (MFWS) from Day 0 to Days 30, 90, and 270
Time Frame: Days 30, 90, and 270
Days 30, 90, and 270
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
Days 30, 90, 180 and Day 270
Subject satisfaction
Time Frame: Days 30, 90, 180, and 270
Subject satisfaction at Days 30, 90, 180, and 270
Days 30, 90, 180, and 270
Global Aesthetic Improvement
Time Frame: Days 30, 90, 180, and 270
Global Aesthetic Improvement Scale (GAIS) at Days 30, 90, 180, and 270
Days 30, 90, 180, and 270
Adverse events
Time Frame: Days 0, 14, 30, 90, 180, 270
Days 0, 14, 30, 90, 180, 270

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (ESTIMATE)

February 26, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 30, 2014

Last Update Submitted That Met QC Criteria

July 29, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PVN1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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