Status and phase
Conditions
Treatments
About
The clinical investigation is a randomized, subject- and evaluator-blinded, active treatment controlled, multicenter, clinical investigation, to demonstrate the non inferiority of saypha® VOLUME Lidocaine to one of the devices approved for the same indication (Juvéderm® Voluma™ XC).
Full description
This will be a multi-center, randomized, double-blind, comparator-controlled study. The study will take place in the EU and US with approximately 17 sites.
The purpose of the current clinical investigation is to evaluate the effectiveness, safety and long-term safety of saypha® VOLUME Lidocaine for the correction of age-related moderate to severe volume deficit in the midface (augmentation of midface volume deficit), and to demonstrate its non-inferiority to one of the devices approved for the same indication (Juvéderm® Voluma™ XC). In addition, the duration of the aesthetic effect after implantation will be studied.
Approximately 486 subjects in total will be randomized and treated resulting in 437 evaluable subjects for the primary endpoint. Randomization will be in a 2:1 ratio (test device: 324, comparator device: 162).
Each subject will take part in the investigation for up to 92 weeks. The total anticipated duration of the investigation, from the first-subject-first visit to the last-subject-last-visit, is around 114 weeks, based on expected recruitment period of about 22 weeks.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria: (baseline treatment)
Male or female subjects aged 22 - 75 years (inclusive) of age at Screening.
Subjects with bilateral, approximately symmetric moderate to severe midface volume deficit (severity scores of 2 or 3 on the 5-point Midface Volume Deficit Severity Scale), as assessed by the blinded investigator at the site.
Females of childbearing potential must have a negative urine pregnancy test and must agree to use a highly effective method of birth control throughout the entire study.
Males subjects with female partners of child-bearing potential must agree to use contraception throughout the entire study (surgical sterilization or a physical barrier such as a condom).
Healthy skin in the midface area and free of diseases that could interfere in cutaneous aging evaluation.
Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of entire investigation, including botulinum toxin injection (except glabella or forehead botulinum toxin treatment).
Subjects who understand the purpose and conduct of the study and having given written informed consent and are willing and able to attend the study visits as judged by the investigator.
Exclusion Criteria: (baseline treatment)
Inclusion criteria: (touch-up treatment)
Exclusion criteria: (touch-up treatment)
Inclusion criteria: (repeat-treatment)
Exclusion criteria: (repeat-treatment)
Primary purpose
Allocation
Interventional model
Masking
486 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal