The Evaluation of Efficacy and Safety of Stylage® XL Lidocaïne for the Restoration and/or Augmentation of Facial Volume

NCT04166292 | Completed

• 1 other identifier: 2019-A01404-53
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Healthy

Keywords

augmentation; restoration; dermal filler; face; cheekbone; chin; mandibular angle; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• Variation of facial volume

  Facial volume variation from baseline to 6 months after treatment initiation measured by an independent evaluator on photographs using FVLS (Facial Volume Loss Scale). Graded scale from 1-5; 5 being the most severe

  6 months

Secondary Outcomes (8)

• Variation of facial volume

  Month 1, Month 3, Month 12, Month 18

• Treatment responders rate

  Month 1, Month 3, Month 6, Month 12, Month 18

• Global aesthetic improvement

  Month 1, Month 3, Month 6, Month 12, Month 18

• Patient self-assessed aesthetic improvement

  Month 1, Month 3, Month 6, Month 12, Month 18

• Variation of volume on the cheekbones, and on the chin for applicable subjects

  Month 1, Month 3, Month 6, Month 12, Month 18

Study Arms (1)

Treated face

EXPERIMENTAL

The device will be injected on V1 (D0) in the cheekbones (upper part of the cheek) for all subjects and in the chin for 20 subjects minimum and if needed (optional areas) in the temple, and facial oval (mandibular angle and border). A touch-up is possible in one or several of these areas on V2 (M1). Optional treated areas will be at the discretion of subjects and injectors.

Device: Stylage® XL Lidocaïne

Interventions

Stylage® XL Lidocaïne DEVICE

On V1 (D0), a total volume of 8 mL maximum can be used per subject on the whole face. On V2 (M1), a possible touch-up can be made according to the injector and subject's opinion which cannot exceed 4 ml.

Treated face

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Subject;
• Sex: male or female;
• Age: between 30 and 65 years;
• Subject having given freely and expressly his informed consent;
• Subject requiring injection on the cheekbones (upper part of the cheek);
• Subject with grade from 3 to 5 on the Facial Volume Loss Scale (FVLS);
• Subject, psychologically able to understand the study related information and to give a written informed consent;
• Subject affiliated to a health social security system;
• Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study and during all the study;
• Subject agreeing to keep their usual cleansing / care products during the whole study period;
• Subject agreeing to apply a Sun Protection Factor (SPF) 50 cream during non-intensive exposure to sunlight.

You may not qualify if:

• In terms of population
• Pregnant or nursing woman or planning a pregnancy during the study;
• Subject with a scar, moles or anything on the face which might interfere with the evaluation;
• Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship;
• Subject in a social or sanitary establishment;
• Subject having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study.
• Intensive exposure to sunlight or Ultraviolet-rays (UV-rays) within the month before each visit;
• In terms of associated pathology
• Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results;
• Subject with known history of or suffering from autoimmune disease and/or immune deficiency;
• Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders
• Subject having history of allergy or anaphylactic shock including hypersensitivity to hyaluronic acid or to one of the components of the tested device;
• Subject having history of allergy or anaphylactic shock including hypersensitivity to amide-type local anaesthetics or antiseptic solution;
• Subject with a past history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats;
• Subject with a tendency to develop keloids or hypertrophic scars;

Sponsors & Collaborators

• Laboratoires Vivacy: lead

Study Sites (1)

Laboratoire DERMSCAN

Villeurbanne, Rhône, 69100, France

Location

MeSH Terms

Conditions

Facies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alain-Ali MOJALLAL, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The facial volume loss will be retrospectively assessed by a blinded independent evaluator using the Facial Volume Loss Scale (FLVS) on 3D photographs from V1 (D0 before) and at the following visits: V2 (D30 before), V3 (D90), V4 (D180), V5 (D360) and V6 (D540). The evaluator is blinded to treatment and visit number. The overall improvement level will be retrospectively assessed by a blinded independent evaluator using the GAIS on 3D photographs at the following visits (in comparison with 3D photographs before injection): V2 (D30 before), V3 (D90), V4 (D180), V5 (D360) and V6 (D540). The evaluator is blinded to treatment and visit number.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 18, 2019
• Study Start: November 21, 2019
• Primary Completion: July 15, 2020
• Study Completion: August 7, 2021
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)