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

NCT01798498 | Completed Results

• 1 other identifier: PVN1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

• 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 1. Fine wrinkle: visible wrinkle and slight indentation 1.5 Visible wrinkle and clear indentation, \<1 mm wrinkle depth 2. 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 3. Deep wrinkle: deep and furrow wrinkle; more than 3 mm wrinkle depth

  From Day 0 to Day 180

Secondary Outcomes (4)

• Change in the Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Days 30, 90, and 270

  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)

  Days 30, 90, 180, and 270

• Subject Satisfaction

  Days 30, 90, 180, and 270

• Global Aesthetic Improvement Scale (GAIS)

  Days 14, 30, 90, 180, 270

Other Outcomes (2)

• Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day

  Day 0 to Day 14, 30, 90, 180, and 270

• Improvement in MFWS in One or Both Nasolabial Folds Over Time

  Day 0 to Day 30, 90, 180, and 270

Study Arms (1)

Princess® VOLUME

EXPERIMENTAL

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

Interventions

Princess® VOLUME DEVICE

Also known as: highly cross-linked, viscoelastic hyaluronic acid injectable gel implant

Princess® VOLUME

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Croma-Pharma GmbH: lead
• FGK Clinical Research GmbH: collaborator

Study Sites (3)

Medical University Graz

Graz, Austria

Location

Ordination 1

Vienna, Austria

Location

Ordination 2

Vienna, Austria

Location

Results Point of Contact

• Title: Head of Clinical Operations
• Organization: Croma Pharma

clinical.studies@croma.at

+43 2262 68468

Study Officials

• Daisy Kopera, Prof. Dr.

  Department of Dermatology and Gerontology, Medical University Graz

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: February 26, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 25, 2025
• Results First Posted: February 25, 2025

Record last verified: 2024-12

Locations

AU (3)