Clinical Study to Evaluate the Efficacy and Safety of Dermalax(Deep) in Correction of Nasolabial Folds

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2012
The study is to verify that Dermalax (Deep) is not inferior to the reference device, Restylane®, in terms of efficacy and safety in the correction of nasolabial folds. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intradermally injected both of study device and comparator device. Subjects will be randomized to receive injection of study device and comparator device on their each nasolabial fold. Efficacy is evaluated based on the change in Wrinkle Severity Rating Scale (WSRS) from baseline. Safety will be assessed based on 24 weeks follow up visits and subject diary which will be given to subjects during the first 2 weeks after the injection. Any uncomfortable things and adverse events will be investigated from subject diary and follow up visits.
Epistemonikos ID: 739d8063096d5f68ac14405fc4e8c5bf9171e8f0
First added on: May 11, 2024