Revance starts Phase 2 clinical trial of RT001 in axillary hyperhidrosis

The randomized, double-blinded, dose-ranging, placebo-controlled Phase 2 trial will evaluate the safety and efficacy of a single, bilateral application of RT001 topical gel for the treatment of primary axillary hyperhidrosis.

The company plans to enroll a total of about 60 adult patients at several sites in the US. Interim data from the study is expected to be released by the end of this year.

An interim efficacy and safety analysis at Day 28 after treatment is proposed.

Revance said the primary efficacy endpoints include the proportion of subjects who are 2-point or larger responders from baseline using the hyperhidrosis disease severity scale and the absolute change from baseline in the gravimetrically measured sweat production.

Secondary efficacy endpoints are the change from baseline in total dermatology life quality index scores.

Hyperhidrosis affects about 9 million people in the US, with around half suffering from axillary hyperhidrosis.

Revance Therapeutics president and CEO Dan Browne said: We believe our needle-free approach may provide a targeted, painless, and long-lasting alternative, without daily application or the systemic side effects observed in many other hyperhidrosis treatments.

"We also believe RT001 could dramatically expand the toxin market for excessive underarm sweating and bring new patients into the physician’s office.

"Although this program’s initial focus is on underarm hyperhidrosis, excessive sweating is often experienced in the palms, feet, and face. These represent potential future indications for us to pursue with RT001 topical gel."