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Completed

NCT Number: NCT01798498

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.

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Key information

Conditions

Nasolabial Folds

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Princess® VOLUME

Device

Other names: highly cross-linked, viscoelastic hyaluronic acid injectable gel implant

Primary outcomes

  1. Change in Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Day 180

    Time frame: 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

Secondary outcomes

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

    Time frame: 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

  2. Percentage of Subjects With an Improvement of at Least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS)

    Time frame: Days 30, 90, 180, and 270

    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

  3. Subject Satisfaction

    Time frame: Days 30, 90, 180, and 270

    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 improved
    • Much improved
    • Slightly improved
    • No change
    • Worsened
    • Question 2: How satisfied are you with the treatment (to be asked at Days 30 and 270):
    • Very satisfied
    • Satisfied
    • Not satisfied
    • Question 3: Would you recommend the treatment to your friends and acquaintances (to be asked at Days 30 and 270):
    • Yes
    • Perhaps
    • No

  4. Global Aesthetic Improvement Scale (GAIS)

    Time frame: Days 14, 30, 90, 180, 270

    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'.

Other outcomes

  1. Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day

    Time frame: Day 0 to Day 14, 30, 90, 180, and 270

    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

  2. Improvement in MFWS in One or Both Nasolabial Folds Over Time

    Time frame: Day 0 to Day 30, 90, 180, and 270

    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

Sponsors and collaborators

Lead sponsor

Croma-Pharma GmbH

Industry

Collaborators

  • FGK Clinical Research GmbH

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 26, 2013
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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