Daewoong Pharmaceutical said Monday that it has published the U.S. phase 3 clinical trial results for Nabota, its botulinum toxin (BTX) product, in an international journal.
|Daewoong Pharmaceutical's botulinum toxin Nabota|
The published study is a multicenter open-label, randomized, controlled phase 3 clinical study, which compared the efficacy of Nabota and placebo in the treatment of moderate to severe wrinkle on 654 U.S. patients.
In the study, the company Nabota and placebo at the same dose in patients, aged 18 and older, with moderate to severe wrinkles, to confirm the wrinkle improvement effect by using the Glabellar Line Scale (GLS)
As a result, 67.5 percent of medical professionals and 70.4 percent of patients answered that their wrinkles improved at least two scales on the GLS meter after a month of treatment. Such results marked a significant difference from the 1.2 and 1.3 percent response rates in the placebo group, demonstrating the superior wrinkle-reducing effect of Nabota versus placebo.
At the 120th and 150th days after the procedure, the response rate was superior to placebo, while the company obtained the same results in the Global Aesthetic Improvement Scales, which evaluates the symptom improvement after receiving BTX.
Daewoong also reported no drug-related adverse cases.
“This publication of SCI-grade papers has proved once again the safety and efficacy of Nabota,” said Kenneth Beer, the lead researcher for the trial. “We hope that it will become a standard for future selection of BTX products.”
Head of Daewoong’s Nabota business division Park Sung-soo, also said, “The effectiveness and safety of Nabota have been proven in global clinical results. We will continue to strengthen our position as a global brand through various opportunities.”
The results of the study were published in the latest issue of Dermatologic Surgery.
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