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

Volume Deficiency of the Midface Clinical Trial

— 05DF1707  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03869450
• Other study ID #: 05DF1707
• Status: Completed
• Phase: N/A
• Start date: November 9, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: April 2020
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Volume Deficiency of the Midface

Intervention

Device:
• Restylane Volyme
Hyaluronic based filler
• Restylane Defyne
Hyaluronic based filler
• Restylane Lyft Lidocaine
Hyaluronic based filler

Locations

Country	Name	City	State
Germany	Galderma Research Site	Munich
Italy	Galderma Research Site	Palermo
United Kingdom	Galderma Research Site	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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