Face; Atrophy
Conditions
Keywords
Nasolabial Folds
Brief summary
Study DA-13-007 is a randomized, evaluator-blinded, within subject (split face) multicenter clinical study of DA-13-007l (Injectable poly-l-lactic acid) compared to SCULPTRA in the treatment of nasolabial fold wrinkles. Qualifying subjects will be randomized to receive DA-13-007l and SCULPTRA on either the right or left side of the face.
Detailed description
A randomized, evaluator-blinded, within subject (split face) multicenter clinical study of DA-13-007 (Injectable poly-l-lactic acid) compared to SCULPTRA in the treatment of nasolabial fold wrinkles. Qualifying subjects will be randomized to receive DA-13-007 and SCULPTRA on either the right or left side of the face. The treatment phase will consist of one to three visits at 3 week intervals during which eligible subjects will receive bilateral injections of study material in the left and right nasolabial fold wrinkles, including visits at weeks 3 and 6 for touch ups if needed. The follow-up phase will consist of assessments at 1, 3, 6, and 12 months after the last treatment, and safety and efficacy evaluations for an additional 12 months. Standardized photographs will be taken at screening and at all treatment phase and follow-up visits. Efficacy evaluations will be made by an on-site blinded evaluator, and of the photographs using a validated, standardized photo-numeric scale. The primary efficacy comparison between study treatments will be made on the mean change from baseline in the Wrinkle Severity Rating Scale of the nasolabial folds (as determined by the on-site blinded evaluator) and at the 12 month time point. Study participants will continue to be followed for safety and efficacy at months 18 and 24 after their last injection session.
Interventions
DEVICEDA-13-007 right with left side Sculptra left side
The treatment phase will consist of one to three visits at 3 week intervals during which eligible subjects will receive bilateral injections of study material in the left and right nasolabial fold wrinkles, including visits at weeks 3 and 6 for touch ups if needed
DEVICEDA-13-007 left with left side Sculptra right side
The treatment phase will consist of one to three visits at 3 week intervals during which eligible subjects will receive bilateral injections of study material in the left and right nasolabial fold wrinkles, including visits at weeks 3 and 6 for touch ups if needed
Sponsors
DermAvance
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 1\. Outpatient, male or female subjects of any race 21 years or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at the Baseline Visit (test must have a sensitivity of at least 50U/mL for human chorionic gonadotropin) and practice a reliable method of contraception throughout the study. 1. A female is considered of childbearing potential unless she is * postmenopausal for at least 12 months prior to study drug administration; * without a uterus and/or both ovaries; or * has been surgically sterile for at least 6 months prior to study drug administration. 2. Reliable methods of contraception are: * hormonal methods or intrauterine device in use \>30 days prior to study drug administration; or * barrier methods plus spermicide in use at least 14 days prior to study drug administration * vasectomized partner at least 3 months post operative or a zero sperm count post operatively 2. Demonstrate clinical evidence of moderate to severe bilateral aging in the nasolabial area, with wrinkles classified as a grade 3 or grade 4 on a 5-grade WSRS. 3\. Committed to abstain from procedures interfering with the treatment outcome (
Exclusion criteria
) throughout the study. 4\. Able to understand the requirements of the study and sign Informed Consent and Photography Release forms.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of treatment vs Comparator (using a 5-grade WSRS (wrinkle severity rating scale) score and a rating by an independent evaluator) | One Year | To evaluate the efficacy of treatment versus the comparator in a non-inferiority statistical model using a 5-grade WSRS (wrinkle severity rating scale) score and a rating by an independent evaluator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the Global aesthetic improvement as assessed by investigators and subjects | Two Year | • To evaluate the Global aesthetic improvement (GAI) as assessed by investigators and subjects |
| To evaluate subjects satisfaction using a six point subject satisfaction questionnaire. | Two Year | To evaluate subjects satisfaction using a six point subject satisfaction questionnaire. |
Countries
United States
Outcome results
None listed