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

NCT03203174 | Completed Phase 1

• 1 other identifier: 561309
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperhidrosis

Keywords

microneedle; botulinum toxin; botox; palmar hyperhidrosis; sweating; hyperhidrosis

Outcome Measures

Primary Outcomes (2)

• subjective patient reported Hyperhidrosis Disease Severity Scale (HDSS)

  a scale from 1 to 4. Values of 1 or 2 represent Mild/moderate disease, and 3 or 4 represent severe disease.

  1 month follow up

• objective gravimetric measurement

  collecting sweat secretion on standardized filter, difference in the weight (g) will allow calculation of sweat secretion in grams per 5 minutes

  1 month follow up

Study Arms (2)

Split-hand Microneedle Botulinum Toxin A

EXPERIMENTAL

One palm with microneedle pretreatment prior to application of topical botulinum toxin A

Device: Microneedle; Drug: Botulinum Toxin Type A; Other: Saline

Split-hand Sham Microneedle Botulinum Toxin A

SHAM COMPARATOR

Contralateral palm with sham microneedle pretreatment prior to application of topical botulinum toxin A

Device: Sham Microneedle; Drug: Botulinum Toxin Type A; Other: Saline

Interventions

Microneedle DEVICE

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

Split-hand Microneedle Botulinum Toxin A

Sham Microneedle DEVICE

Flat roller with no needles on the roller

Split-hand Sham Microneedle Botulinum Toxin A

Botulinum Toxin Type A DRUG

Botulinum toxin type A will be applied to the palm

Split-hand Microneedle Botulinum Toxin A; Split-hand Sham Microneedle Botulinum Toxin A

Saline OTHER

Saline applied to the palm

Split-hand Microneedle Botulinum Toxin A; Split-hand Sham Microneedle Botulinum Toxin A

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older (split-hand microneedle group only)
• years of age and older (split-hand botulinum toxin A group)
• Subjects with palmar hyperhidrosis

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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Publications (3)

• Sivamani RK, Stoeber B, Liepmann D, Maibach HI. Microneedle penetration and injection past the stratum corneum in humans. J Dermatolog Treat. 2009;20(3):156-9. doi: 10.1080/09546630802512679.

  PMID: 19016065 BACKGROUND

• Sivamani RK, Liepmann D, Maibach HI. Microneedles and transdermal applications. Expert Opin Drug Deliv. 2007 Jan;4(1):19-25. doi: 10.1517/17425247.4.1.19.

  PMID: 17184159 BACKGROUND

• Sivamani RK, Stoeber B, Wu GC, Zhai H, Liepmann D, Maibach H. Clinical microneedle injection of methyl nicotinate: stratum corneum penetration. Skin Res Technol. 2005 May;11(2):152-6. doi: 10.1111/j.1600-0846.2005.00107.x.

  PMID: 15807814 BACKGROUND

MeSH Terms

Conditions

Hyperhidrosis

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subject's received treatment to one palm and the other palm was used as a control.

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: June 29, 2017
• Study Start: January 1, 2015
• Primary Completion: August 2, 2016
• Study Completion: August 2, 2016
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

US (1)