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Long-term Safety Study of Glycopyrronium in Subjects With Primary 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: NCT02553798
Recruitment Status : Completed
First Posted : September 18, 2015
Results First Posted : September 25, 2018
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Journey Medical Corporation

Study Description
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Brief Summary:
This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or DRM04-HH05 studies.

Condition or disease Intervention/treatment Phase
Hyperhidrosis Drug: Glycopyrronium Topical Wipes Phase 3

Detailed Description:
Safety will be assessed through adverse events, blood and urine laboratory tests, physical examination, pulse and blood pressure. Local skin reactions will be assessed including burning/stinging, pruritus, edema, erythema, dryness and scaling.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 564 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study Assessing Long-term Safety of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
Study Start Date : August 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Glycopyrronium
Glycopyrronium Topical Wipes
 Drug: Glycopyrronium Topical Wipes
Glycopyrronium Topical Wipes
Other Name: DRM04


Outcome Measures
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Primary Outcome Measures :
  1. Long-term Safety Assessed Through Adverse Events and Local Skin Reactions [ Time Frame: Day 1 - Week 44 ]
    The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.


Other Outcome Measures:
  1. Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 [ Time Frame: Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET ]
    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.

  2. Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) [ Time Frame: Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET ]
    Hyperhidrosis Disease Severity Scale (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.

  3. Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 44/ET [ Time Frame: Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET ]
    The Dermatology Life Quality Index 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:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80% treatment compliance
  • Male or females

Exclusion Criteria:

  • Subject has a clinically significant abnormality on physical exam, vital signs or ECG at the Week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further treatment with glycopyrronium contraindicated
  • Male with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy
  • Any other condition which, in the judgement of the Investigator, would put the subject at unacceptable risk for participation in the study
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): NCT02553798


Locations
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Sponsors and Collaborators
Journey Medical Corporation
Investigators
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Study Director: Lynne 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: NCT02553798    
Other Study ID Numbers: DRM04-HH06
First Posted: September 18, 2015    Key Record Dates
Results First Posted: September 25, 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