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Trial record 25 of 166 for:    "Sweat Gland Disease"

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

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ClinicalTrials.gov Identifier: NCT03203174
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief 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.

Condition or disease Intervention/treatment Phase
Hyperhidrosis Device: Microneedle Device: Sham Microneedle Drug: Botulinum Toxin Type A Other: Saline Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subject's received treatment to one palm and the other palm was used as a control.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Microneedles With Topical Botulinum Toxin for Treatment of Palmar Hyperhidrosis
Study Start Date : January 2015
Actual Primary Completion Date : August 2, 2016
Actual Study Completion Date : August 2, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Split-hand Microneedle Botulinum Toxin A
One palm with microneedle pretreatment prior to application of topical botulinum toxin A
Device: Microneedle
Microneedles are small needles used to create holes in the stratum corneum (top layer of skin) with relatively low amount of pain.

Drug: Botulinum Toxin Type A
Botulinum toxin type A will be applied to the palm

Other: Saline
Saline applied to the palm

Sham Comparator: Split-hand Sham Microneedle Botulinum Toxin A
Contralateral palm with sham microneedle pretreatment prior to application of topical botulinum toxin A
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




Primary Outcome Measures :
  1. subjective patient reported Hyperhidrosis Disease Severity Scale (HDSS) [ Time Frame: 1 month follow up ]
    a scale from 1 to 4. Values of 1 or 2 represent Mild/moderate disease, and 3 or 4 represent severe disease.

  2. objective gravimetric measurement [ Time Frame: 1 month follow up ]
    collecting sweat secretion on standardized filter, difference in the weight (g) will allow calculation of sweat secretion in grams per 5 minutes



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203174


Locations
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United States, California
UC Davis Department of Dermatology
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis

Publications:
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03203174     History of Changes
Other Study ID Numbers: 561309
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017

Keywords provided by University of California, Davis:
microneedle
botulinum toxin
botox
palmar hyperhidrosis
sweating
hyperhidrosis

Additional relevant MeSH terms:
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Sweat Gland Diseases
Hyperhidrosis
Skin Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents