Aquavit has submitted an investigational new drug (IND) application to the Food and Drug Administration (FDA) for the initiation of its Phase II/III study of Dermatox (aqubotulinumtoxinA), an intradermal injection of botulinum toxin.
It is intended for the temporary improvement of mild to moderate face and neck lines and skin quality.
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Titled ‘Safety and Efficacy of AqubotulinumtoxinA for Enhanced Skin Quality Index (SAFESQIN)’, the study will enrol adults younger than 65 years of age.
Aquavit CEO Sobin Chang said: “We are excited about the clinical trials of Dermatox and strongly believe in its ability to thrive in the ultra-competitive dermatology space.”
Physicians will be able to safely address the skin’s thinner layers to improve quality and reduce fine lines on a broad surface, including the complete area of the face and neck.
Aquavit CMO Churlsu Kwon said: “While existing botulinum toxins focus only on intramuscular injections of moderate to severe lines on a very specific area, Dermatox would be the first approved for the improvement of overall skin quality, cementing Dermatox as a groundbreaking treatment option.”
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By GlobalDataAqubotulinumtoxinA has also been approved for use in Asia, South America and the Middle East.
It is also currently in phase III clinical trials in many other territories.
