Phase
Condition
Menopause
Treatment
Sculptra Aesthetic
Restylane SkinBoosters Vital
Clinical Study ID
Ages 40-65 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must voluntarily sign and date an informed consent, approved by anindependent ethics committee, prior to the initiation of any screening orstudy-specific procedures.
post-menopausal participants between the age of 40 and 65 years old;
Participants with a -menopausal status (at least 12 consecutive months of amenorrheawithout other pathological or physiological causes).
• A clinical evaluation will be undertaken by a clinical professional to determinepost-menopausal status.
Participants with established clinical signs of skin aging including but not limitedto: reduced skin elasticity, increased wrinkling, dryness, volume loss and/orcontour deficits.
Participant is willing and able to comply with procedures required in the protocol.
Participant must be in good health as per investigator's judgment based on medicalhistory
For subgroup analysis: either currently on stable-dose HRT for ≥ 6 months or notreceiving any form of HRT for ≥6 months
Exclusion
Exclusion Criteria:
Previous biostimulators 18 months prior to this study;
Previous SP-HA 18 months prior to this study;
Previous HA injectables 18 months prior to study in the facial and décolleté region;
Participant has an uncontrolled systemic disease.
Participant presents with or has a history of any medical condition that may placethe participant at an increased risk following exposure to hyaluronic acid orinterfere with the study evaluation, 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 dermatochalasis, deep dermal scarring, excessively thick sebaceous skin,or excessively photodamaged skin
Participant has a history of clinically significant medical conditions or any otherreason that the investigator determines would interfere with the participant'sparticipation in this study or would make the participant an unsuitable candidate toreceive the study medical device.
Participant has a history of an allergic reaction or significant sensitivity toconstituents of the study medical device (or its excipients) including Vicryl
Participant has an tattoos, jewellery, or clothing which obscure the treatment areaand cannot be removed.
Participant has an anticipated need for surgery or overnight hospitalization duringthe study.
Participant has a history of surgical procedures in intended treatment areas,including any lifting procedure (e.g., facial lift, suture lift, thread lift, browlift, eyelid and/or eyebrow surgery, neck lift).
Participant with known active COVID infection within 14 days of baseline treatment.
Participant is currently enrolled in another clinical study.
Participant is presenting with porphyria.
Participant presents with active disease, such as inflammation, infection or tumors,in or near the intended treatment sites.
Participant has a bleeding disorder or take thrombolytics or anticoagulants.
Participant has a need to take immunosuppressants.
Participant has undergone dental procedures including teeth cleaning withing 14 daysprior to baseline treatment
Participant has undergone any vaccine administration withing the 14 days prior totreatment administration
Participant categorised as a heavy smoker, more than 12 cigarettes per day
Study Design
Study Description
Connect with a study center
Erevna Innovations Inc.
Montreal 6077243, Quebec 6115047 H3Z 1C3
CanadaSite Not Available

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