Face; Atrophy Clinical Trial
Official title:
A Controlled, Randomized, Within-subject, Multi-center Prospective Clinical Trial of DermaVeil (Injectable Poly-L-lactic Acid) Versus SCULPTRA® Aesthetic (Injectable Poly-L-lactic Acid) in the Treatment of Nasolabial Fold Wrinkles.
Study DA-13-007 is a randomized, evaluator-blinded, within subject (split face) multicenter clinical study of DermaVeil (Injectable poly-l-lactic acid) compared to SCULPTRA in the treatment of nasolabial fold wrinkles. Qualifying subjects will be randomized to receive DermaVeil and SCULPTRA on either the right or left side of the face.
A randomized, evaluator-blinded, within subject (split face) multicenter clinical study of DermaVeil (Injectable poly-l-lactic acid) compared to SCULPTRA in the treatment of nasolabial fold wrinkles. Qualifying subjects will be randomized to receive DermaVeil 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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05734248 -
Fractional Laser Drug Delivery of a Local Anesthetic
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N/A |