Clinical Research Directory

Recombinant Collagen Freeze-Dried Fibre for Upper Facial Wrinkles

The goal of this clinical trial was to learn whether a collagen filler improved facial wrinkles. The study product was injectable recombinant collagen freeze-dried fibers. Recombinant collagen is collagen made using genetic engineering. Participants were adults aged 18 to 65 with upper facial wrinkles. These included forehead lines, lines between the eyebrows, and lines beside the eyes. The trial also studied the product's safety. The main questions it aimed to answer were: * How many participants had fewer wrinkles 90 days after their final treatment? * What side effects or other medical problems occurred during treatment and follow-up? Researchers compared the study product with Sunmax Collagen Implant I, another collagen filler. They compared how many participants improved in each group. Improvement meant wrinkles became at least one level less severe in every treated area. Researchers used a five-level scale to rate wrinkle severity. The comparison allowed a small difference in improvement rates between the groups. Researchers set this limit before the trial began. They tested whether the study product stayed within that limit compared with the other filler. Participants were asked to: * Receive one of the two products, with their group chosen by chance. * Receive three injection treatments, about 30 days apart. * Record reactions in a diary for 14 days after each treatment. * Attend follow-up visits about 30, 90, and 180 days after their final treatment. * Have facial photographs taken for wrinkle assessments. * Rate changes in their appearance and report any medical problems.