CompletedPhase 1

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

United States13 participantsStarted 2015-01

Plain-language summary

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.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

subjective patient reported Hyperhidrosis Disease Severity Scale (HDSS)

Timeframe: 1 month follow up

objective gravimetric measurement

Timeframe: 1 month follow up

Trial details

NCT IDNCT03203174

SponsorUniversity of California, Davis

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-08-02

View on ClinicalTrials.gov More Hyperhidrosis trials