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Completed

NCT Number: NCT02016885

A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis

The purpose of this study is to evaluate the safety and efficacy of glycopyrrolate compared to vehicle for the treatment of axillary hyperhidrosis.

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Key information

Conditions

Hyperhidrosis Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Burke Pharmaceutical Research, Hot Springs, Arkansas, United States

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About this study

This is a randomized, vehicle controlled, dose-ranging study enrolling subjects with axillary hyperhidrosis and designed to assess the safety and efficacy of four doses of glycopyrrolate compared to vehicle. There are 5 arms in this study.

Efficacy will be assessed through the Hyperhidrosis Disease Severity Score (HDSS), Dermatology Life Quality Index (DLQI) and a gravimetric assessment of sweat production.

Safety will be assessed, at specified times during the study, through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.

PK samples will be taken from 20 to 30 subjects participating in the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, 18 years of age or older.
  • Primary, axillary hyperhidrosis of at least 6 months duration.
  • A Hyperhidrosis Disease Severity Score (HDSS) of 3or 4.
  • A gravimetric measurement of sweat production of at least 50 mg over 5 minutes in each axilla (total of 100 mg) while at rest at room temperature.
  • Male or non-pregnant, non-lactating females.

Exclusion criteria

  • Prior surgical procedure for hyperhidrosis.
  • Any prior treatment with an axillary anti-hyperhidrosis medical device (approved or investigational)
  • Prior treatment with botulinum toxin for axillary hyperhidrosis within 1 year.
  • Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis. Treatment with psychotherapeutic medications for less than 4 months prior to study enrollment. - Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks prior to enrollment.
  • Prior axillary treatment with axillary iontophoresis within 4 weeks.
  • Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
  • Known history of a condition that may cause secondary hyperhidrosis.
  • Known history of Sjögren's syndrome or Sicca syndrome.
  • Abnormal findings on screening ECG deemed clinically significant by the Investigator.

Treatment and study plan

glycopyrrolate, 1.0%

Drug

glycopyrrolate Topical Wipes, 1.0%

Other names: DRM04B

glycopyrrolate, 2.0%

Drug

glycopyrrolate Topical Wipes, 2.0%

Other names: DRM04B

glycopyrrolate, 3.0%

Drug

glycopyrrolate Topical Wipes, 3.0%

Other names: DRM04B

glycopyrrolate, 4.0%

Drug

glycopyrrolate Topical Wipes, 4.0%

Other names: DRM04B

Vehicle

Other

Vehicle Topical Wipes

Other names: Placebo

Primary outcomes

  1. Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4

    Time frame: Baseline - Week 4

    HDSS is a disease specific diagnostic tool that provides a qualitative measure of the severity of the subjects' condition based on how it affects daily activities.

    1 (Best), 2, 3, 4 (Worst)

  2. Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 4

    Time frame: Baseline - Week 4

    Subjects are acclimated to the environment for 30 minutes. Dry gauze is weighed. The dry gauze is then applied to the subject's axilla with the arm down by the subject's side or on their lap during the 5-minute period of sweat production. The gauze with the sweat is then weighed. The difference between the Weight of the gauze with sweat and the dry gauze is the gravimetric sweat measurement in mg/5min.

Secondary outcomes

  1. Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4

    Time frame: Baseline - Week 4

  2. Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6

    Time frame: Baseline - Week 6

  3. Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6

    Time frame: Baseline - Week 6

  4. Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 4

    Time frame: Baseline - Week 4

    The DLQI is a ten question questionnaire, used to measure the impact of skin disease on the quality of life of an affected person. The scoring of each question is as follows: Very much (3), A lot (2), A little (1), Not at all (0), Not relevant (0). Is calculated by summing the score of each question resulting in a max of 30 and a min of 0. Higher the score the more Quality of life is impaired.

Sponsors and collaborators

Lead sponsor

Journey Medical Corporation

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Vehicle Controlled, Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 20, 2013
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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