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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
161
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 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
Bay Area Dermatology
Bradenton, Florida, United States
Miami Skin Institute
Coral Gables, Florida, United States
Laser & Skin Surgery Center of Indiana
Carmel, Indiana, United States
PCR
Spokane, Washington, United States
Efficacy of treatment vs Comparator (using a 5-grade WSRS (wrinkle severity rating scale) score and a rating by an independent evaluator)
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
Time frame: One Year
To evaluate the Global aesthetic improvement as assessed by investigators and subjects
• To evaluate the Global aesthetic improvement (GAI) as assessed by investigators and subjects
Time frame: Two Year
To evaluate subjects satisfaction using a six point subject satisfaction questionnaire.
To evaluate subjects satisfaction using a six point subject satisfaction questionnaire.
Time frame: Two Year
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