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Candesant Biomedical Announces Positive Safety and Efficacy Data for Treatment of Hyperhidrosis
Novel treatment offers hope for people who suffer from excessive sweating
SAN FRANCISCO, Oct. 25, 2018 (GLOBE NEWSWIRE) -- Candesant Biomedical (“Candesant”), a company dedicated to alleviating the suffering of those affected by excessive sweating and hyperhidrosis, today announced the initial safety and efficacy data from its STAYDRi.1 trial on CDX-101, an innovative, non-invasive energy device. The open label study showed the device is well tolerated and presents statistically significant efficacy in reduction of sweating, most notably a 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 variety of patient-reported measures.
One-third of adults in the United States suffer negative lifelong impact on their quality of life due to excessive sweating, and a subset (almost 5%) sweat so much it is considered a medical condition. With few treatment options available, sufferers must adjust their lifestyles to cope with this condition, or endure invasive procedures associated with discomfort, side effects, and at times variable efficacy.
Candesant is developing CDX-101, a non-invasive solution for excessive sweating that is designed to be used in a quick, no-downtime procedure administered in a physician’s office. Candesant’s novel water activated technology is designed to specifically target and inactivate the most active sweat glands, and aims to provide long lasting effect without the discomfort or time commitment of other treatments.
The CDX-101 STAYDRi.1 clinical study followed subjects for six weeks, evaluating both safety and effectiveness using quantitative and qualitative endpoints of gravimetric sweat production, Hyperhidrosis Disease Severity Scale (HDSS), and other quality of life measures. The 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.
“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,” said Jeremy B. Green, MD FAAD, of Skin Associates of South Florida/Skin Research Institute, and a principal investigator in the study.
Key findings from the STAYDRi.1 study include:
- The mean sweat production reduced by 71% at week 4 (n=9, p=0.0008).
- Over the entire course of the 6-week follow-up period, subjects saw an average weekly sweat reduction of 69%.
- At the end of the initial 6-week study 89% of respondents were still showing significant sweat reduction.
- The study also demonstrated consistent improvement in quality of life across several measurements including HDSS with 89% of subjects reporting improvement at week 4.
- Strong safety profile, with few cases of mild and transient redness or irritation.
Dee Anna Glaser, MD, Interim Chairman of the Department of Dermatology of St. Louis University and President of the International Hyperhidrosis Society, found that “the impressive results from the STAYDRi.1 trial could represent a promising future treatment for a group of patients whose quality of life is negatively impacted by this condition. The study yielded terrific insights into efficacy and duration and could offer a new treatment paradigm for my patients who sweat excessively and are not satisfied with options currently available.”
CDX-101 is a single-use, non-invasive solution designed to provide effective, rapid treatment for sweat reduction. CDX-101 employs a novel water activated technology that is designed to specifically target and inactivate the most active sweat glands in a quick physician’s office procedure with minimal discomfort, and no downtime.
About Candesant Biomedical
Founded in 2016 by proven innovators and entrepreneurs in the dermatology and aesthetic medicine industry, Candesant is a privately-held company dedicated to developing novel solutions for excessive sweating and hyperhidrosis. With Candesant’s initial product, CDX-101, our goal is to provide a simple, elegant device that offers significant sweat reduction without the pain and tradeoffs of existing therapies. For more information, visit www.candesant.com.
Niquette Hunt, CEO