The Use of Microneedles With Topical Botulinum Toxin for Treatment of Palmar Hyperhidrosis

Completed · Phase 1 · Has a placebo group

Conditions studied: Hyperhidrosis

In brief

Hyperhidrosis or sweating of palms results from the overactivity of sweat glands and leads to psychosocial impairment with reduction in quality of life in those that are affected. Injection of botulinum toxin has been shown to be effective in reducing the symptoms of hyperhidrosis with associated improvement in quality of life, but is usually very painful. Microneedles are a different modality for transdermal drug penetration without the pain. This study aims to understand if botulinum toxin A can be delivered topically after microneedle pretreatment in hopes of developing a minimally painful treatment protocol for treatment of palmar hyperhidrosis.

Key facts

Study ID

NCT03203174

Run by

University of California, Davis

People needed

13

Starts

2015-01-01

Expected to finish

2016-08-02

Last updated by the study team

2017-07-19

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 12 years of age and older (split-hand microneedle group only)
• 18 years of age and older (split-hand botulinum toxin A group)
• Subjects with palmar hyperhidrosis
• Do not meet any of the exclusion criteria

You may not qualify if…

• Subjects who smoke
• Subjects who have established allergy to topical botulinum toxin
• Subjects with a personal or family history of neuromuscular disorder
• Subjects who have had botulinum toxin to the hands in the past 6 months
• Subjects who have had other systemic anticholinergic therapy in the past 2 weeks
• Subjects with known thyroid related disorders or systemic infection.
• Subjects who are pregnant or who plan to become pregnant

Where it is running

• UC Davis Department of Dermatology — Sacramento, California, United States

Full record on ClinicalTrials.gov

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