Hugel said on Friday that it received a clinical study report (CSR) on the phase 1 trial of HG102, a lidocaine-containing liquid botulinum toxin (BTX), on Wednesday.

HG102 is made into liquid from the existing BTX in a freeze-dried powder form. It contains lidocaine hydrogen chloride, a local anesthetic.

In January 2021, Hugel received the regulatory nod to conduct a phase 1 study of HG102.

The company conducted the study at Konkuk University Medical Center on 38 patients with moderate to severe frown lines. The patients randomly received either Hugel’s HG102 (treatment group) or Allergan’s Botox (control group) in the same dose. After a single shot, the researchers compared glabellar lines and safety improvement.

According to the CSR, when patients’ glabellar lines were evaluated in their maximally frowned state, there was no statistically significant difference in the improvement of two or more stages between the treatment and control groups.

In terms of safety, the study did not report any newly identified adverse reactions, and the two groups did not demonstrate a significant difference in the incidence of adverse events.

“The results showed that the administration of HG102 in patients with moderate or severe frown lines could improve frown lines similar to that in the control group,” a Hugel official said. “As there was no newly identified adverse reaction, the treatment can be administered safely.”

Hugel plans to begin a phase 3 trial of HG102 and obtain approval in 2025.