Phase
Condition
N/ATreatment
Restylane line of injectable
Restylane line of injectables
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects must voluntarily sign and date an informed consent, including thephotography addendum allowing unrestricted use of photographs for the benefit ofmarketing and educational purposes, approved by an independent ethics committee,before the initiation of any screening or study-specific procedures.
Subjects must be adult male or female, at least 18 years old.
Subjects must be willing and able to comply with procedures required in theprotocol.
Subjects must be in good health as per the investigator's judgment based on medicalhistory
Female subjects that are not pregnant or breastfeeding and are not consideringbecoming pregnant or donating eggs during the study or for approximately 30 daysafter the last dose of the study medical device or until the end of the study,whichever is longer.
Exclusion
Exclusion Criteria:
Subject with uncontrolled systemic disease.
Subject with or have a history of any medical condition that may place the subjectat increased risk following exposure to hyaluronic acid or interfere with the studyevaluation, including:
Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateralsclerosis, or any other significant disease that might interfere withneuromuscular function
History of facial nerve palsy
Infection or dermatological condition at the treatment injection sites
Marked facial dermatochalasis, deep dermal scarring, excessively thicksebaceous skin, or overly photodamaged skin
Subject with a history of clinically significant medical conditions or any otherreason that the investigator determines would interfere with the subject'sparticipation in this study or would make the subject an unsuitable candidate toreceive the study medical intervention
Subjects with a history of an allergic reaction or significant sensitivity toconstituents of the study medical intervention (or its excipients).
Subjects with porphyria
Subjects with active diseases, such as inflammation, infection or tumours, in ornear the intended treatment sites,
Subjects with bleeding disorders or taking thrombolytics or anticoagulants.
Subjects who need to take immunosuppressants.
Subjects with tattoos, jewelry, or clothing which obscure the treatment area andcannot be removed.
Subjects who have anticipated the need for surgery or overnight hospitalizationduring the study.
Subjects with a history of surgical procedures in the face, including any liftingmethod (e.g., facial lift, suture lift, thread lift, brow lift, eyelid and eyebrowsurgery).
Subjects with a history of facial treatment with semi-permanent or permanent softtissue fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate,polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fattransplantation.
Subjects with known active COVID infection within 14 days of baseline treatment.
Subjects that have been treated with any investigational product within 30 daysbefore the first dose of the study medical device or are currently enrolled inanother clinical study
Study Design
Connect with a study center
Erevna Innovations Inc
Montreal, Quebec H3R 3A1
CanadaSite Not Available
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