Restylane Defyne in a Stepwise Treatment Approach

Completed · Not applicable

Conditions studied: Lower Face Folds and Lines

In brief

This was a 12-week study to evaluate the effectiveness and safety of Restylane Defyne when using two different injection approaches, stepwise down-up vs. top-down, when treating the lower face.

Key facts

Study ID

NCT04520997

Run by

Galderma R&D

People needed

62

Starts

2020-12-07

Expected to finish

2021-09-15

Last updated by the study team

2023-04-14

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects willed to comply with the requirements of the study and provided a signed written informed consent
• Subjects willed to undergo augmentation and correction therapy in the studied indications
• Adult males or non-pregnant, non-breastfeeding females and women of non-child bearing potential over the age of 21

You may not qualify if…

• Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram-positive bacterial proteins
• Previous use of any permanent (non-biodegradable) treatment, lifting threads, permanent implants or autologous fat below the level of the horizontal line from the lower orbital rim
• Participation in any interventional clinical study within 30 days of screening

Where it is running

• Galderma Research Site — Birmingham, Alabama, United States
• Galderma Research Site — Chicago, Illinois, United States
• Galderma Research Site — Belo Horizonte, Brazil
• Galderma Research Site — São Paulo, Brazil
• Galderma Research Site — Palermo, Italy

Full record on ClinicalTrials.gov

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