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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aesthetic Treatment for the Correction of Nasolabial Folds. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of the Hyaluronic Acid-Based Dermal Filler ESTYME® LIFT (Now Marketed as ESTYME® FORM). | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who returned to their baseline (pre-injection) state, as assessed by the investigator using the 6-point nasolabial fold scale (0 = no wrinkle; 6 = very deep wrinkle). | At each follow-up visit, including the 9-24-month visit and the 24-month visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse device effects (ADEs) and serious adverse device effects (SADEs) assessed by the investigator. | From the initial injection (day 0) to the end of the follow-up period (24 months). | |
| Injection site reactions (ISR) assessed by the investigator. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Médical Saint Jean | Arras | 62000 | France | |||
| Cabinet médical |
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|
| Day 0 (after the first injection), Month 1 (after the optional touch-up), and between Month 9 and Month 24 (after the optional retreatment) |
| Investigator-assessed severity of nasolabial folds using the 6-point scale (0 = no wrinkle, 6 = very deep wrinkle) | Assessments were performed before and after each injection (D0: initial injection; M1: optional touch-up; between M9 and M24: optional retreatment), as well as at each follow-up visit, including the 9-24-month and 24-month visits. |
| Aesthetic change, as assessed by the subject compared with baseline, using the 5-point Global Aesthetic Improvement Scale (GAIS) from 'worse' to 'very much improved. | At each follow-up visit, including the 9-24-month visit and the 24-month visit. |
| Lyon |
| 69005 |
| France |
| Palais de Flore | Lyon | 69006 | France |