Hugel "Botulinum Toxin 'Botulax' Also Effective in Improving Negative Psychology of Glabellar Wrinkle Patients"

New Phase 3 Clinical Data Presented at American Society of Dermatologic Surgery Meeting

[Asia Economy Reporter Lee Gwan-joo] Hugel announced on the 11th that it presented the Phase 3 clinical trial results of its botulinum toxin product 'Botulax' in the United States and Europe at the American Society for Dermatologic Surgery (ASDS), held from the 6th to the 10th (local time) in Colorado, USA.

The Phase 3 clinical trial (BLESS III) evaluated the efficacy and safety of Botulax through a randomized, double-blind, placebo-controlled study involving 355 patients with glabellar wrinkles. At this conference, data focusing on psychosocial effects were newly presented.

Glabellar wrinkles are generally known to negatively affect emotional expression, physical attractiveness, self-esteem, and age perception. This clinical trial comprehensively studied social function and emotional changes resulting from the improvement of glabellar wrinkles. The main evaluation indices included the quality of life survey method 'Skindex-16,' FACE-Q assessment related to glabellar wrinkles, visual scales, and treatment satisfaction, with conclusions drawn based on results observed at 4 weeks post-treatment.

The study results showed that patient satisfaction with Botulax treatment reached 89%, and on average, patients felt 2.3 years younger after treatment. In particular, in addition to the improvement of glabellar wrinkles, patients' negative psychological states also improved. Skindex-16 includes items such as negative emotions and discomfort during social activities; the Botulax treatment group showed an average score decrease of 38.4 points, significantly greater than the 0.7-point decrease in the placebo group. FACE-Q score changes were also markedly higher in the Botulax group (46.4 points) compared to the placebo group (-2.9 points), confirming that the degree of psychological change corresponded to the extent of glabellar wrinkle improvement.

A Hugel representative stated, "Through these clinical results, we were able to confirm meaningful evidence that our botulinum toxin product Botulax contributes to alleviating the psychological and social burdens of patients with glabellar wrinkles," adding, "Hugel will continue various academic activities to promote the excellent quality, efficacy, and safety of Botulax in the global market."

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