CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 13 enrolled
Drug / intervention
Botulinum Toxin Type A +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03203174
NCT03203174Phase 1Completed

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

University of California, Davis·interventional·Posted Jun 29, 2017·Updated Jul 19, 2017

In Brief

A Phase 1 clinical trial evaluating Microneedle, Sham Microneedle, and 2 other interventions for Hyperhidrosis. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperhidrosis
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 29, 2017
Enrollment StartJan 1, 2015
Primary CompletionAug 2, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.0 years ago

Interventions

Microneedledevice

Microneedles are small needles used to create holes in the stratum corneum (top layer of skin) with relatively low amount of pain.

Sham Microneedledevice

Flat roller with no needles on the roller

Botulinum Toxin Type Adrug

Botulinum toxin type A will be applied to the palm

Salineother

Saline applied to the palm