Topical Botulinum Toxin Type A Liposomal Cream for Primary Axillary Hyperhidrosis: A Double-Blind, Randomized, Split-Site, Vehicle-Controlled Study

Dermatol Surg. 2018 Aug;44(8):1094-1101. doi: 10.1097/DSS.0000000000001532.

Abstract

Background: Despite its effectiveness in treating primary axillary hyperhidrosis (PAH), topical botulinum toxin type A (BTX-A) is highly resistant to transdermal absorption. Topical BTX-A liposomal cream is recommended as a novel, noninvasive modality to enhance skin penetration.

Objective: To evaluate the efficacy and safety of topical BTX-A liposomal cream in comparison with liposomal vehicle cream alone in the treatment of PAH.

Materials and methods: A prospective, randomized, double-blinded, split-site study was conducted in 20 subjects, aged 18 to 50 years, all of whom had symmetrical axillary sweating with Hyperhidrosis Disease Severity Scale scores between 2 to 4. All subjects were double-blinded to treatment regimens and randomly given 2 bottles, one containing topical BTX-A liposomal cream and one containing the vehicle cream without BTX-A, to be applied consistently to the same axilla nightly for 7 consecutive days. Clinical improvement and adverse reactions were evaluated at every follow-up visit.

Results: Axillary skin treated with topical BTX-A demonstrated superior sweat reduction and patient satisfaction to vehicle cream-treated axillary skin, with clinical and statistical significance, at baseline, weeks 2, 4, 6, and 8 of follow-up, without adverse effects.

Conclusion: Topical BTX-A liposomal cream pharmaceutically enhances drug delivery, is painless, cost-effective, and overall an innovative treatment of PAH.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Acetylcholine Release Inhibitors / administration & dosage*
  • Administration, Topical
  • Adult
  • Axilla
  • Botulinum Toxins, Type A / administration & dosage*
  • Dosage Forms
  • Double-Blind Method
  • Female
  • Humans
  • Hyperhidrosis / drug therapy*
  • Liposomes
  • Male
  • Prospective Studies

Substances

  • Acetylcholine Release Inhibitors
  • Dosage Forms
  • Liposomes
  • Botulinum Toxins, Type A