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

NCT03203174 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-07-19

No results posted yet for this study

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.

Conditions

  • Hyperhidrosis

Interventions

DEVICE

Microneedle

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

DEVICE

Sham Microneedle

Flat roller with no needles on the roller

DRUG

Botulinum Toxin Type A

Botulinum toxin type A will be applied to the palm

OTHER

Saline

Saline applied to the palm

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-08-02
Completion
2016-08-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03203174 on ClinicalTrials.gov