Clinical trial NCT05355454: Study of STYLAGE® XXL for Volume Deficiency in the Mid-Face
Official title: A Multicenter, Prospective, Randomized Controlled Clinical Study of STYLAGE® XXL Versus No-Treatment for Volume Deficiency in the Mid-face
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Volume Deficiency in the Mid-Face
Aging
Aesthetics
Keywords: Mid-Face
Hyaluronic Acid
Volume
Aging
Aesthetics
Lead sponsor: Laboratoires Vivacy
Sponsor class: INDUSTRY
Collaborators: name: Avania B.V.
name: Canfield Scientific Inc.
First posted: 2022-05-02
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-Center, Prospective, Randomized, No-Treatment Controlled Trial. Subjects will be randomized (5:1 ratio) to the STYLAGE® XXL (treatment) arm or the no-treatment control arm.

After 24 weeks, the no-treatment control arm (delayed treatment group) will receive their first treatment and will then follow the same schedule as the initial treatment group. After the no-treatment control group receives treatment, data from both groups will be pooled.
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to demonstrate the superiority of STYLAGE® XXL versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face.

Detailed description: This is a multicenter, prospective, randomized, no-treatment controlled post-market clinical follow-up of a class III medical device. This study is designed to evaluate the safety and effectiveness of STYLAGE® XXL in the restorationor creation of volume in the mid-face.

The objective of this study is to demonstrate the superiority of STYLAGE® XXL versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face.

Assessment of superiority will be based on 3D analysis of the volumetric change, using a validated imaging system.

Effectiveness of STYLAGE® XXL will be demonstrated if the mean volumetric change at 24 weeks after baseline from pre-treatment in the treatment group is statistically superior to the mean change in the delayed treatment (control) group.

In total, approximately 90 subjects will be enrolled across three study centers in Switzerland, Austria, and France.

Subjects will be randomized to the treatment group or delayed treatment (control) group at a 5:1 ratio (i.e., there will be 5 more subjects treated with STYLAGE® XXL at baseline as compared to subjects who will be in the no-treatment (control) group and who will receive a delayed treatment with STYLAGE® XXL at 24 weeks after baseline).

The total duration of subject participation ranges from 18-19 months (treatment group) to 24-25 months (delayed treatment (control) group). Overall study duration including the enrolment period is expected to take approximately 30-31 months.

Eligibility criteria: Inclusion Criteria:

* Aged between 30 and 65 years
* Seeking correction of his/her mid-face volume deficit, and agrees with recommendation by the Investigator
* Accept the obligation not to receive any other facial procedures or treatments impacting facial volume augmentation at any time during the study
* Able to follow study instructions and likely to complete all required visits, as assessed by the Investigator
* Psychologically able to understand the study related information and to give a written informed consent
* Have voluntarily provided written informed consent to participate in the study, and use of data privacy (sign the ethics committee approved Informed Consent Form), prior to any study-related procedure being performed
* Female of childbearing potential (sexually active, not sterile, nor postmenopausal for at least 1 year) must have a negative urine pregnancy test (UPT) at Visit 1 (or Visit 1b), and use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study and for the duration of the study
* Affiliated to a health social security system (for France only)

Exclusion Criteria:

In terms of population:

* Pregnant or breastfeeding woman, or planning a pregnancy during the study
* Scars, moles, tattoo, 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 participating to another research on human beings or who is in an exclusion period of one
* Subject having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study (for France only)

In terms of associated pathology:

* Subject presenting any symptom which can be related to a medical condition that is likely to make the subject not being compliant with the study schedule, at the discretion of the investigator
* 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 suffering from active inflammatory and/or infectious cutaneous disorders in or near the studied zones (e.g. herpes, acne). Subject with recurrent herpes in the Midface area is not eligible even if asymptomatic at time of inclusion
* 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 with a history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats with cardiac localisation
* Subject with a tendency to develop keloids or hypertrophic scars

Relating to previous or ongoing treatment:

* Subject having received treatment with a laser, a dermabrasion, a surgery, a peeling, or other ablative procedure on the Midface area within the past 12 months prior to inclusion
* Subject having received injection with a resorbable filling product in the Midface area within the past 18 months prior to inclusion
* Subject having received at any time injection with a slowly resorbable filling product (e.g. polylactic acid, calcium hydroxyapatite, combinations of HA and Hypromellose) or with a non-resorbable filling product (e.g. polyacrylamide or silicone)
* Subject having received at any time a treatment with tensor threads in the Midface area
* Subject under medications which may cause lipo-atrophy
* Subject using medication such as aspirin, NSAIDs (e.g. ibuprofen), antiplatelet agents, anticoagulants, vitamin C within one week prior to inclusion and not agreeing not to take such treatments within 1 week prior to visit 2 (M1) or being a chronic user of anticoagulant treatment
* Subject undergoing a topical treatment on the test area or a systemic treatment:
* Antihistamines during the 2 weeks prior to study start
* Immunosuppressors and/or corticoids during the 4 weeks prior to study start
* Retinoids during the 6 months prior to study start

Primary outcomes:
measure: Mid-Face Volumetric change
timeFrame: 24 weeks after baseline
Secondary outcomes:
measure: Mid-Face Volumetric change
timeFrame: 4, and 12 weeks after baseline
measure: Mid-Face Volumetric change
timeFrame: 4, 12, 24, 48, and 72 weeks after initial treatment
measure: Global Aesthetic Improvement, by the Subjects
timeFrame: 4, 12, and 24 weeks after baseline
measure: Global Aesthetic Improvement, by the Subjects
timeFrame: 4, 12, 24, 48, and 72 weeks after initial treatment
measure: Global Aesthetic Improvement, by the Investigators
timeFrame: 4, 12, and 24 weeks after baseline
measure: Global Aesthetic Improvement, by the Investigators
timeFrame: 4, 12, 24, 48, and 72 weeks after initial treatment
measure: FACE-Q, by the Subjects
timeFrame: Baseline, and 4, 12, and 24 weeks after baseline
measure: FACE-Q, by the Subjects
timeFrame: Initial treatment, and 4, 12, 24, 48, and 72 weeks after initial treatment
measure: Wrinkle Severity Rating Scale (WSRS), by the Investigators.
timeFrame: 4, 12, and 24 weeks after baseline
measure: Wrinkle Severity Rating Scale (WSRS), by the Investigators.
timeFrame: 4, 12, 24, 48, and 72 weeks after initial treatment
measure: Ease of sculpting and massaging, by the Investigators
timeFrame: Initial treatment, and 4, and 72 weeks after initial treatment
Other outcomes:
Locations:
city: Arras
country: France
facility: Centre Medical Saint Jean
Study officials:
affiliation: Private Clinic, GENEVA, SWITZERLAND
name: Hervé RASPALDO, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Medical Saint-Jean, ARRAS, FRANCE
name: Hugues CARTIER, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Aesthetic Research Academy, GRAZ, AUSTRIA
name: Thomas RAPPL, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Practice, NICE, FRANCE
name: Cyril CLERICO, MD
role: PRINCIPAL_INVESTIGATOR
References: