Real-Life Evaluation of the HA Dermal Filler ESTYME® LIFT
NCT07385053 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96
Last updated 2026-02-03
Summary
The objective of this post-market interventional study is to confirm, under real-life conditions, the safety and performance of a hyaluronic acid-based dermal filler intended for the aesthetic correction of nasolabial folds. The primary question addressed by the study is: How long does the effect of the product last? Following the initial injection session, which includes an optional touch-up planned one month after the first injection, participants will attend a follow-up visit scheduled between 9 and 24 months after the initial treatment. During this visit, patients may receive a retreatment if they wish.
The flexibility of the follow-up window between 9 and 24 months was defined to allow patients to return on their own initiative for retreatment, thereby indicating the end of the effect of the initial injection session. A final follow-up visit is also scheduled at 24 months.
At each visit, the investigator will assess both performance and safety through a clinical examination. In addition, at each follow-up visit, participants will evaluate the aesthetic improvement compared with their pre-injection appearance.
Conditions
- Nasolabial Folds, Wrinkles
Interventions
- DEVICE
-
Injection of the Hyaluronic Acid-Based Dermal Filler ESTYME® LIFT (Now Marketed as ESTYME® FORM).
The device will be used under real-life conditions. Following the initial injection session, an optional touch-up may be performed one month after the first injection. A retreatment session may be offered to the patient between 9 and 24 months after the initial injection.
Sponsors & Collaborators
-
Symatese
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-06-05
- Primary Completion
- 2026-04-30
- Completion
- 2026-04-30
Countries
- France
Study Locations
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