This is a pivotal, prospective active-controlled, randomized, double blinded (blinded evaluator and subject), intra-individual split-face comparison, non-inferiority study of DKL crosslinked sodium hyaluronate 23 versus Juvederm Volift™ after injection into the mid to deep dermis for correction of moderate to deep nasolabial folds (NLFs).
This is a pivotal, prospective active-controlled, randomized, double blinded (blinded evaluator and subject), intra-individual split-face comparison, non- inferiority study of DKL crosslinked sodium hyaluronate 23 versus Juvederm Volift™ after injection into the mid to deep dermis for correction of moderate to deep nasolabial folds (NLFs). Approximately 40 subjects will be randomized and treated. Subjects will come to the research clinic for up to 6 visits, including a screening/baseline visit and up to 5 follow-up visits. At Screening eligible subjects (males and females aged 18 to 65 years) will be randomized as to which NLF will be treated with the investigational device and which NLF will be treated with the comparator device. The subjects will undergo baseline assessments of NLF Wrinkle Severity Rating Scale (WSRS) by the evaluating investigator and have baseline two-dimensional (2D) photos taken, prior to treatment with the investigational device and comparator. Treatment will be performed by an unblinded treating investigator. Following treatment, the subjects will complete a subject eDiary in which they will assess pre-defined treatment related events experienced during the first 14 days after the injection. Additional visits will take place 1, 3, 6 and 9 months after the treatment. During these visits the subjects will undergo evaluations by an evaluating investigator blinded to the treatment allocation. Assessments will include photography, NLF WSRS and Global Aesthetic Improvement Scale (GAIS). The subjects will also evaluate treatment outcome using the GAIS and complete a patient satisfaction questionnaire. The investigator will record any adverse events (AEs) that have occurred and will note their severity and relationship to the injected product. An optional touch-up treatment will be performed one month after the initial treatment at the discretion of the treating investigator. Subjects requiring touch-up will receive touch-up according to the original randomization scheme, i.e. the investigational device and comparator product will be injected to the same NLF according to the randomization scheme. Following touch-up, these subjects will be asked to complete a subject eDiary for assessment of pre-defined treatment related events experienced during the first 14 days after the injection. Subjects receiving touch-up will attend and additional evaluation visit one month after touch-up (in addition to other visits). The treating investigators will complete a usability questionnaire.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
is injected into the NLF on Day 1. The volume of injection will not exceed 2 mL per side. If applicable, a touch-up of DKL crosslinked sodium hyaluronate 23 will be injected on Day 30; the volume of injection will not exceed 1 mL per side.
is injected into the NLF on Day 1. The volume of injection will not exceed 2 mL per side. If applicable, a touch-up of Juvéderm Volift™ will be injected on Day 30; the volume of injection will not exceed 1 mL per side.
CTC Clinical Trial Consultants AB
Uppsala, Sweden
Comparison of the rate of responders determined by the aesthetic improvement of the NLFs according to live on-site evaluator-rated NLF WSRS at 6 months post-treatment between the investigational device and comparator product.
The NLF WSRS is a 5-point scale ranging from 1 (No visible fold; continuous skin line) to 5 (Extremely deep and long folds; detrimental to facial appearance; 2- to 4-mm visible V-shaped fold when stretched). Response is defined as ≥ 1-point improvement on the NLF WSRS for each NLF compared to baseline. Each NLF is to be assessed separately.
Time frame: Baseline (pre-treatment) to 6 months post-treatment
Comparison of the rate of responders determined by the aesthetic improvement of the NLFs according to live on-site evaluator-rated NLF WSRS at 1, 3 and 9 months post-treatment between the investigational device and comparator product.
The NLF WSRS is a 5-point scale ranging from 1 (No visible fold; continuous skin line) to 5 (Extremely deep and long folds; detrimental to facial appearance; 2- to 4-mm visible V-shaped fold when stretched). Response is defined as ≥ 1-point improvement on the NLF WSRS for each NLF compared to baseline. Each NLF is to be assessed separately.
Time frame: Baseline (pre-treatment) to 1, 3 and 9 months post-treatment
Comparison of the mean change in evaluator-rated NLF WSRS from baseline (pre-treatment) to at 1, 3, 6 and 9 months post-treatment between the investigational device and comparator product.
The NLF WSRS is a 5-point scale ranging from 1 (No visible fold; continuous skin line) to 5 (Extremely deep and long folds; detrimental to facial appearance; 2- to 4-mm visible V-shaped fold when stretched).
Time frame: Baseline (pre-treatment) to 1, 3, 6 and 9 months post-treatment
Subject-rated aesthetic improvement in appearance according to GAIS at 1, 3, 6 and 9 months post-treatment. Each NLF is to be assessed separately.
The 5-grade GAIS assesses the appearance of the NLF compared to pre-treatment on a scale ranging from very much improved to worse.
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Time frame: Baseline (pre-treatment) to 1, 3, 6 and 9 months post-treatment
Evaluating Investigator-rated aesthetic improvement in appearance according to the GAIS at 1, 3, 6 and 9 months post-treatment. Each NLF is to be assessed separately.
The 5-grade GAIS assesses the appearance of the NLF compared to pre-treatment on a scale ranging from very much improved to worse.
Time frame: Baseline (pre-treatment) to 1, 3, 6 and 9 months post-treatment
Usability of the device
Investigator-reported usability of the device. A device usability questionnaire will be completed once by each treating investigator after treatment of his/her last subject.
Time frame: Baseline - treatment
Subject-reported satisfaction with treatment as assessed by a subject satisfaction questionnaire at 1, 3, 6 and 9 months post-treatment.
Satisfaction will be assessed on a 5-point scale ranging from very satisfied (1) to very dissatisfied (5).
Time frame: 1, 3, 6 and 9 months post-treatment
Post-treatment events
Incidence, intensity, and duration of pre-defined expected post-treatment events collected using a subject electronic diary (eDiary) for 14 days post treatment.
Time frame: Up to 14 days post-treatment
Adverse Events
Frequency, intensity and seriousness of adverse events (AEs).
Time frame: Up to 9 months post-treatment