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OpenTrials
Completed

NCT Number: NCT03869450

A Study to Evaluate Effectiveness and Safety of Hyaluronic Acid (HA) Fillers

The purpose of the study is to investigate the degree of improvement in appearance after treatment with different hyaluronic acid (HA) fillers. Product selection is based on Investigator assessment of participant tissue coverage and main treatment goal (volumizing, lifting or contouring).

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Key information

Conditions

Volume Deficiency of the Midface

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Galderma Research Site, Munich, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male/Female 25 to 55 years old that needs lifting, contouring or volumization of the midface
  • Signed and dated informed consent

Exclusion criteria

  • Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel and lidocain
  • Previous use of any permanent or semi-permanent facial tissue augmentation therapy or contouring with, lifting threads, permanent implants, or autologous fat in the treatment area
  • Previous use of any HA or collagen based facial tissue augmentation therapy in the facial area, any previous use of neurotoxin or any previous facial surgery
  • Any medical condition that in the opinion of the Investigator would make the participant unsuitable for inclusion

Treatment and study plan

Restylane Volyme

Device

Hyaluronic based filler

Restylane Defyne

Device

Hyaluronic based filler

Restylane Lyft Lidocaine

Device

Hyaluronic based filler

Primary outcomes

  1. Percentage of Participants With Aesthetic Improvement of Midface

    Time frame: 8 weeks

    A blinded evaluator assesses the improvement compared to baseline (pre-treatment) using a 5-graded scale; Worse, No change, Improved, Much improved or Very much improved. Aesthetic improvement of midface is defined as those participants assessed as Improved, Much improved or Very much improved.

Secondary outcomes

  1. Percentage of Participants With Improved Midface Volume

    Time frame: 8 weeks

    A blinded evaluator assessed the fullness of the midface by using a 4-graded scale where 1= fairly full and 4= substantial loss of fullness.

    Improved midface volume was defined as at least a 1-grade decrease from baseline.

  2. Percentage of Participants Assessed as Having Natural Treatment Results

    Time frame: 8 weeks

    Blinded evaluator assessed participants by answering Strongly agree/Agree/Neither agree nor disagree/Disagree/Strongly disagree to the question "Are the subject's treatment results natural looking?". Having natural treatment results is defined as being assessed with answers Strongly agree or Agree.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Multi-center, Evaluator-blinded Study to Evaluate Effectiveness and Safety of HA Fillers for Lifting, Contouring and Correcting Volume Deficiency of the Midface Using an Individualized Treatment Algorithm

Acronym: 05DF1707

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 11, 2019
Registry last updated
Aug 26, 2022

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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