Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
Study NCT ID:
NCT04166292
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2019-11-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Evaluation of Efficacy and Safety of Stylage® XL Lidocaïne for the Restoration and/or Augmentation of Facial Volume
Sponsor:
Laboratoires Vivacy
Organization:
Study Overview
Official Title:
A Prospective, Monocentric, Uncontrolled Clinical Investigation to Evaluate the Efficacy and Safety of Stylage® XL Lidocaïne for the Restoration and/or Augmentation of Facial Volume
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BeautyVolume
Brief Summary:
Stylage® XL Lidocaïne is a CE-marketed hyaluronic acid gel indicated for the restoration or augmentation of facial volume by injection into the deep dermis or subcutaneously. Lidocaine hydrochloride is intended to reduce the pain associated with the injection.
In this study 40 healthy subjects between the age of 30 and 65 years, presenting a volume deficit on the face as evaluated by the investigator at inclusion in the study, who have given his/her informed consent and met all the eligibility criteria, will be enrolled.
Subjects will come to a total of 6 visits over a period of 18 months and a screening visit prior to baseline injection. The facial volume variation after baseline injection will be assessed. Treatment responders rate, Global Aesthetic Improvement, volume on the cheekbones, volume on the chin and chin angle (for applicable subjects), subject's satisfaction and safety will be also assessed.
In this study 40 healthy subjects between the age of 30 and 65 years, presenting a volume deficit on the face as evaluated by the investigator at inclusion in the study, who have given his/her informed consent and met all the eligibility criteria, will be enrolled.
Subjects will come to a total of 6 visits over a period of 18 months and a screening visit prior to baseline injection. The facial volume variation after baseline injection will be assessed. Treatment responders rate, Global Aesthetic Improvement, volume on the cheekbones, volume on the chin and chin angle (for applicable subjects), subject's satisfaction and safety will be also assessed.
Detailed Description:
This is a prospective, uncontrolled, single site study with a blinded evaluator assessing the efficacy of Stylage® XL Lidocaïne on FVLS and GAIS clinical scoring.
The study duration by subject is 18 months with a screening visit (V0) before injection, the baseline visit (injection of Stylage® XL Lidocaïne, V1) and 5 follow-up visits after 1, 3, 6, 12 and 18 months (V2 to V6). At 1 month (V2) an optional touch-up may be done (if needed).
The primary endpoint is the facial volume variation from baseline (D0) to 6 months after treatment initiation measured by an independent evaluator on photographs using FVLS (Facial Volume Loss Scale).
Facial volume variation (evaluated by an independent evaluator) \& treatment responder rate, Global Aesthetic Improvement (evaluated by the patient and the doctor), volume on the cheekbones and chin \& chin angle (for applicable subjects), subject's satisfaction will be measured at all time-point with a FVLS, GAIS,3D QuantifiCare system, FACE-Q questionnaire (cheekbones and chin) respectively. Safety will be also assessed.
The study duration by subject is 18 months with a screening visit (V0) before injection, the baseline visit (injection of Stylage® XL Lidocaïne, V1) and 5 follow-up visits after 1, 3, 6, 12 and 18 months (V2 to V6). At 1 month (V2) an optional touch-up may be done (if needed).
The primary endpoint is the facial volume variation from baseline (D0) to 6 months after treatment initiation measured by an independent evaluator on photographs using FVLS (Facial Volume Loss Scale).
Facial volume variation (evaluated by an independent evaluator) \& treatment responder rate, Global Aesthetic Improvement (evaluated by the patient and the doctor), volume on the cheekbones and chin \& chin angle (for applicable subjects), subject's satisfaction will be measured at all time-point with a FVLS, GAIS,3D QuantifiCare system, FACE-Q questionnaire (cheekbones and chin) respectively. Safety will be also assessed.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: