A Study to Evaluate Effectiveness and Safety of Hyaluronic Acid (HA) Fillers (05DF1707)

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

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).

Study Overview

• Status: Completed
• Conditions: Volume Deficiency of the Midface
• Intervention / Treatment: Device: Restylane Volyme; Device: Restylane Defyne; Device: Restylane Lyft Lidocaine

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 80636
    • Galderma Research Site
• Italy
  • Palermo, Italy, 90141
    • Galderma Research Site
• United Kingdom
  • Edinburgh, United Kingdom, EH10 4BE
    • Galderma Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Restylane Volyme; According to the treatment algorithm, treated with Restylane Volyme	Device: Restylane Volyme; Hyaluronic based filler
EXPERIMENTAL: Restylane Defyne; According to the treatment algorithm, treated with Restylane Defyne	Device: Restylane Defyne; Hyaluronic based filler
EXPERIMENTAL: Restylane Lyft Lidocaine; According to the treatment algorithm, treated with Restylane Lyft Lidocaine	Device: Restylane Lyft Lidocaine; Hyaluronic based filler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Aesthetic Improvement of Midface	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Improved Midface Volume	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.	8 weeks
Percentage of Participants Assessed as Having Natural Treatment Results	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.	8 weeks

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 9, 2018
• Primary Completion (ACTUAL): August 30, 2019
• Study Completion (ACTUAL): August 30, 2019

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (ACTUAL): March 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Immunologic Factors; Protective Agents; Membrane Transport Modulators; Adjuvants, Immunologic; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Viscosupplements; Lidocaine; Hyaluronic Acid
• Other Study ID Numbers: 05DF1707

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No