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.
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.”
AqubotulinumtoxinA 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.