NCT04520997

Restylane Defyne in a Stepwise Treatment Approach

A Randomized, Evaluator-Blinded Study to Evaluate Facial Harmony and Subject Satisfaction Using Restylane Defyne in a Stepwise Treatment Approach

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lower Face Folds and Lines

Interventions

Type	Name	Description
DEVICE	Restylane Defyne	Up to 2 milliliters (ml) of Restylane Defyne per treatment site (chin and surrounding area) with maximum of total 4 ml at baseline, up to 2 ml of Restylane Defyne per NLF and ML at week 3 and optional up to 2 ml of Restylane Defyne per facial half for NLF and ML in combination with a total of 2 ml in the chin and surrounding area at week 6.
DEVICE	Restylane Defyne	Up to 2 ml of Restylane Defyne per NLF and ML at baseline, up to 2 ml of Restylane Defyne per treatment site (chin and surrounding area) with maximum of total 4 ml at week 3 and optional touch-up of up to 2 ml per facial half for NLF and ML in combination with a total of 2 ml in the chin and surrounding area at week 6.

Timeline

• Start date: 2020-12-07
• Primary completion: 2021-09-15
• Completion: 2021-09-15
• First posted: 2020-08-20
• Last updated: 2023-04-14
• Results posted: 2023-04-14

Locations

5 sites across 3 countries: United States, Brazil, Italy

Regulatory

• FDA-regulated device study