Status:
COMPLETED
Study of STYLAGE® XXL for Volume Deficiency in the Mid-Face
Lead Sponsor:
Laboratoires Vivacy
Collaborating Sponsors:
Avania B.V.
Canfield Scientific Inc.
Conditions:
Volume Deficiency in the Mid-Face
Aging
Eligibility:
All Genders
30-65 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05355454
Start Date
June 6 2022
End Date
April 25 2025
Last Update
September 10 2025
Active Locations (1)
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1
Centre Medical Saint Jean
Arras, France