Candesant Biomedical has announced positive initial safety and efficacy data from its STAYDRi.1 trial on CDX-101, a new non-invasive energy device for treating hyperhidrosis.
According to Candesant Biomedical, the open label study showed that the device is well tolerated and offers statistically significant efficacy in reducing sweat.
The company claims that there was nearly 71% decrease in quantitative sweat production from baseline to Week 4 (p=0.0008) after a single treatment.
The study also showed consistent improvement in quality of life across a wide range of patient-reported measures.
Candesant Biomedical says that nearly one-third of adults in the US suffer lifelong negative impact on quality of life because of excessive sweating and a subset of about 5%, sweat so much it is considered a medical condition.
There are only few treatment options available and patients must adjust their lifestyles to cope with this condition or will have to go through invasive procedures associated with discomfort, side effects and at times variable efficacy.
The company is developing CDX-101, which is a non-invasive solution for excessive sweating. It has been designed for use as a quick procedure that can be administered in a physician’s office.
The device works on water activated technology and is designed to specifically target and inactivate the most active sweat glands and aims to offer long lasting effect without any discomfort for patients.
The study followed patients for six weeks, evaluating both safety and effectiveness using quantitative and qualitative endpoints of gravimetric sweat production for Hyperhidrosis Disease Severity Scale (HDSS) and other quality of life measures.
Results from the study were presented this month at the American Society for Dermatologic Surgery (ASDS) Annual Meeting in Phoenix, Arizona and the Fall Clinical Dermatology Conference in Las Vegas, Nevada.
Findings from the study show that the mean sweat production reduced by 71% at week 4 (n=9, p=0.0008). Over the entire 6-week follow-up course, patients saw an average weekly sweat reduction of 69%.
At the end of the 6-week study 89% of patients were still showed significant sweat reduction. The study also showed improvement in quality of life across several measurements including HDSS with 89% of subjects reporting improvement at week 4.
South Florida/Skin Research Institute Skin Associates and a principal investigator in the study Jeremy B. Green said: “The findings of the STAYDRi.1 trial demonstrate that CDX-101 represents a truly novel and potentially exciting treatment option for patients suffering from hyperhidrosis and excessive sweating. The ability to significantly reduce sweat production for at least six weeks with an efficient and well-tolerated procedure remains an unmet need for our patients, and this data suggests that CDX-101 may satisfy that need.”