A Pivotal Study on the Safety and Effectiveness of a Targeted Alkali Thermolysis Patch for Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary Sweating

Authors

Stacy Smith, California Dermatology and Clinical Research Institute, Encinitas, California.
Dee Anna Glaser, Glaser Dermatology & Aesthetics LLC, St. Louis, Missouri.
Lawerence J. Green, Dept of Dermatology, George Washington University School of Medicine, Washington, District of Columbia.
Micheal S. Kaminer, SkinCare Physicians, Chestnut Hill, Massachusetts.
Erin Tims, Candesant Biomedical, Nashville, Tennessee.
David M. Pariser, Eastern Virginia Medical School and Virginia Clinical Research, Inc., Norfolk, Virginia.

Document Type

Journal Article

Publication Date

10-31-2024

Journal

Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]

DOI

10.1097/DSS.0000000000004472

Abstract

BACKGROUND: One-third of US adults are bothered by excessive sweating, approximately 5% are diagnosed with hyperhidrosis. A topical patch using targeted alkali thermolysis (TAT) was developed for treatment of this condition. OBJECTIVE: This study was intended to assess the efficacy and safety of the TAT-Patch for axillary sweat reduction. MATERIALS AND METHODS: A randomized, multicenter, double-blind, sham-controlled, pivotal trial enrolled 120 subjects to a bilateral axillary treatment with a TAT patch (63 subjects) or sham patch (57 subjects). RESULTS: The primary end point was achieved; 64% of TAT-treated versus 44% of sham-treated subjects (p = .0332) improved from Hyperhidrosis Disease Severity Scale (HDSS) 3/4 to HDDS 1/2 at 4 weeks. Targeted alkali thermolysis treatment also showed a statistically significant improvement over sham treatment for all secondary end points, including gravimetric sweat production and subject-reported quality-of-life (QoL) assessments. The duration of effect is approximately 3 months, determined by the time to return to baseline HDSS. Mild-to-moderate treatment-site adverse events (AEs) were reported in 22% of TAT patch subjects. No serious or severe AEs were reported. CONCLUSION: HDSS, GSP, and QoL findings confirm clinically meaningful sweat reduction and a significant improvement in quality of life following a single TAT patch treatment. This device has potential to offer a new, noninvasive treatment option that is well tolerated with minimal downtime.

APA Citation

Smith, Stacy; Glaser, Dee Anna; Green, Lawerence J.; Kaminer, Micheal S.; Tims, Erin; and Pariser, David M., "A Pivotal Study on the Safety and Effectiveness of a Targeted Alkali Thermolysis Patch for Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary Sweating" (2024). GW Authored Works. Paper 5752.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/5752

Department

Dermatology