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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02016885
Recruitment Status : Completed
First Posted : December 20, 2013
Results First Posted : September 13, 2018
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Journey Medical Corporation

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

Condition or disease Intervention/treatment Phase
Hyperhidrosis Drug: glycopyrrolate, 1.0% Drug: glycopyrrolate, 2.0% Drug: glycopyrrolate, 3.0% Drug: glycopyrrolate, 4.0% Other: Vehicle Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Vehicle Controlled, Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
Study Start Date : November 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: glycopyrrolate, 1.0%
glycopyrrolate Topical Wipes, 1.0%
 Drug: glycopyrrolate, 1.0%
glycopyrrolate Topical Wipes, 1.0%
Other Name: DRM04B
Experimental: glycopyrrolate, 2.0%
glycopyrrolate Topical Wipes, 2.0%
 Drug: glycopyrrolate, 2.0%
glycopyrrolate Topical Wipes, 2.0%
Other Name: DRM04B
Experimental: glycopyrrolate, 3.0%
glycopyrrolate Topical Wipes, 3.0%
 Drug: glycopyrrolate, 3.0%
glycopyrrolate Topical Wipes, 3.0%
Other Name: DRM04B
Experimental: glycopyrrolate, 4.0%
glycopyrrolate Topical Wipes, 4.0%
 Drug: glycopyrrolate, 4.0%
glycopyrrolate Topical Wipes, 4.0%
Other Name: DRM04B
Placebo Comparator: Vehicle
Vehicle Topical Wipes
 Other: Vehicle
Vehicle Topical Wipes
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT02016885


Locations
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Sponsors and Collaborators
Journey Medical Corporation
Investigators
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Study Director: Lynne M Deans, MT Dermira, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Journey Medical Corporation
ClinicalTrials.gov Identifier: NCT02016885    
Other Study ID Numbers: DRM04-HH01
First Posted: December 20, 2013    Key Record Dates
Results First Posted: September 13, 2018
Last Update Posted: August 25, 2021
Last Verified: August 2021
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
Glycopyrrolate
Adjuvants, Anesthesia
Muscarinic Antagonists
 Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs