Facial Wrinkles
Conditions
Keywords
Nasolabial folds, Dermal filler, Injectable dermal filler, Soft tissue augmentation
Brief summary
This is a randomized, double-blind pivotal study to evaluate the safety and effectiveness of CosmetaLife injectable dermal filler for the correction of wrinkles and folds, such as nasolabial folds (i.e., smile lines).
Detailed description
Patients with negative reaction skin test results will be randomized to receive CosmetaLife in one nasolabial fold and Control in the nasolabial fold on the opposite side of the face (split face design). Each subject will serve as his or her own control, allowing for comparison of the outcome between the contralateral sides. Patients will be followed at 2 weeks and 3, 6, 9 and 12 months post treatment for assessment of safety and effectiveness.
Interventions
DEVICECosmetaLife
Dermal filler
DEVICERestylane
Dermal filler
Sponsors
Cosmeta Corp, A Gel-Del Technologies Company
Cosmeta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients 18 years of age or older 2. Patients with moderate nasolabial folds (3-4 WSRS scale) 3. Patients willing to provide written informed consent for their participation in the study 4. Patients willing to abstain from other facial cosmetic procedures through the 12 month follow-up visit
Exclusion criteria
1. Patients with any aesthetic facial therapy within 6 months prior to 2. Patients with an any reaction to the skin test 3. Patients with a history of autoimmune disorder, lidocaine reactions, allergy to heparin, other severe or chronic allergies 4. Patients with a current disease state that can effect the immunoresponse, or patients on immunosuppressive therapy 5. Patients with an active infection of any kind, skin disease, connective tissue disorder 6. Patients who are pregnant or lactating 7. Patients enrolled in another investigational clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wrinkle Severity Rating Scale | baseline and 6 months | To determine if the mean change in the 5-point Wrinkle Severity Rating Scale (WSRS) score at 6 months was non-inferior to the contralateral Control Restylane treated side, where on this 5-point scale 1 has no measurable nasolabial fold, 2 has some fold, 3 has moderate fold, 4 has heavier moderate fold, and a 5 has deep to a very deep nasolabial fold. For this study only moderate nasolabial folds were included (i.e., 3 or 4), where subjects scored as 5 were excluded. |
| Adverse Event Reporting | 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months | 3, 9 and 12 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CosmetaLife vs Restylane Split-face double blind study design used so each subject received each treatment followed by a two week touch up treatment, where no subject received more than 2cc of either CosmetaLife or Restylane treatment. | 145 |
| Total | 145 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 14 |
Baseline characteristics
| Characteristic | CosmetaLife vs Restylane |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 23 Participants |
| Age, Categorical Between 18 and 65 years | 122 Participants |
| Age Continuous | 53.9 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 145 participants |
| Sex: Female, Male Female | 135 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 145 | 0 / 145 |
| serious Total, serious adverse events | 0 / 145 | 0 / 145 |
Outcome results
Primary
Adverse Event Reporting
Time frame: 6 months
Primary
Change in Wrinkle Severity Rating Scale
To determine if the mean change in the 5-point Wrinkle Severity Rating Scale (WSRS) score at 6 months was non-inferior to the contralateral Control Restylane treated side, where on this 5-point scale 1 has no measurable nasolabial fold, 2 has some fold, 3 has moderate fold, 4 has heavier moderate fold, and a 5 has deep to a very deep nasolabial fold. For this study only moderate nasolabial folds were included (i.e., 3 or 4), where subjects scored as 5 were excluded.
Time frame: baseline and 6 months
Population: Analysis was intention to treat (ITT) and each subject received both CosmetaLife and Control (Restylane) injections into contralateral nasolabial folds, respectively. WSRS units (change from baseline analyzed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CosmetaLife | Change in Wrinkle Severity Rating Scale | -0.94 units on scale | Standard Deviation 0.71 |
| Restylane (Control) | Change in Wrinkle Severity Rating Scale | -1.07 units on scale | Standard Deviation 0.76 |
Comparison: The a priori hypothesis for statistical analysis was based on predetermined clinical relevance being set to a difference score between CosmetaLife and Control (Restylane) of -0.5. This clinical relevance was set to -0.5 because the observation scale used is not accurate below 0.5 differences. That is CosmetaLife needed to be greater than 0.5 less than Control (Restylane) in the treatment difference scores to be considered inferior.90% CI: [-2, 1]Confidence interval
Secondary
Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months
Time frame: 3, 9 and 12 months