CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 62 enrolled
Drug / intervention
Restylane Defyne +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04520997
NCT04520997N/ACompleted

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

Galderma R&D·interventional·Posted Aug 20, 2020·Updated Apr 14, 2023

In Brief

A clinical study evaluating Restylane Defyne for Lower Face Folds and Lines. Completed, enrolled 62 participants across 5 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, Italy, United States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 20, 2020
Enrollment StartDec 7, 2020
Primary CompletionSep 15, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.9 years ago

Interventions

Restylane Defynedevice

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.

Restylane Defynedevice

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.