Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis

August 23, 2021 updated by: Journey Medical Corporation

An Open-label Study Assessing Long-term Safety of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
564

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Klinik für Dermatologie, Venerologie und Allergologie Allergie-Centrum-Charité
      • Dülmen, Germany, 48249
        • Pro DERMA im Hautzentrum Dulmen
      • Friedrichshafen, Germany, 88045
        • Medical Practice and Derma-Study-Center Friedrichshafen GmbH
      • Gera, Germany, 07548
        • SRH Wald-Klinikum Gera GmbH
      • Glückstadt, Germany, 25348
        • Hautarztpraxis
      • Kiel, Germany, 24148
        • Tagesklinik DermaKiel
      • Mahlow, Germany, 15831
        • Dermatolosche Gemeinschaftspraxis
      • Schweinfurt, Germany, 97421
        • Gemeinschaftspraxis Weber & Cranic
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Coastal Medical Research Group LLC
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Northwest Arkansas Clinical Trials Center, PLLC
    • California
      • Encinitas, California, United States, 92024
        • California Dermatology & Clinical Research Institute
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • San Diego, California, United States, 92123
        • Therapeutics Clinical Research
      • Santa Monica, California, United States, 90404
        • Clinical Science Institute
    • Colorado
      • Denver, Colorado, United States, 80210
        • Colorado Medical Research Center, Inc
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Skin Care Research, Inc.
      • Boynton Beach, Florida, United States, 33437
        • Study Protocol, Inc
      • Miami, Florida, United States, 33144
        • International Dermatology Research, Inc.
      • North Miami Beach, Florida, United States, 33162
        • Tory Sullivan, MD
      • West Palm Beach, Florida, United States, 33401
        • Research Institute of the Southeast
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Shideler Clinical Research Center
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center, PC
    • Kansas
      • Wichita, Kansas, United States, 67206
        • Prairie Health and Wellness
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Lawrence J. Green M.D., LLC
    • Minnesota
      • Edina, Minnesota, United States, 55424
        • Zel Skin & Laser Specialist
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • MediSearch Clinical Trials
      • Saint Louis, Missouri, United States, 63122
        • St. Louis University Dermatology
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Meridian Clinical Research
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106-5239
        • Academic Dermatology Associates
    • New York
      • New York, New York, United States, 10022
        • Schweiger Dermatology Group
      • Rochester, New York, United States, 14623
        • Skin Search of Rochester, Inc
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Dermatology and Research Center
    • Pennsylvania
      • Charleston, Pennsylvania, United States, 29414
        • Dermatology and Laser Center of Charleston, PA
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Rivergate Dermatology Research Center, PLLC
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates, Inc
    • Texas
      • Austin, Texas, United States, 78759
        • DermResearch
      • College Station, Texas, United States, 77845
        • J & S Studies, Inc.
      • Dallas, Texas, United States, 75231
        • Modern Research Associates, PLLC
      • Houston, Texas, United States, 77030
        • The University of Texas Dermatology Clinical Research Center
      • Pflugerville, Texas, United States, 78860
        • Austin Institute for Clinical Research
      • Plano, Texas, United States, 75024
        • ACRC Trials
      • San Antonio, Texas, United States, 78218
        • Texas Dermatology and Laser Specialists
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • Dermatology Research Center, Inc.
      • West Jordan, Utah, United States, 84088
        • Jordan Valley Dermatology Center, LLC
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research
      • Norfolk, Virginia, United States, 23507
        • Virginia Clinical Research, Inc.
    • Washington
      • Seattle, Washington, United States, 98101
        • Dermatology Associates
      • Spokane, Washington, United States, 99202
        • Premier Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Glycopyrronium
Glycopyrronium Topical Wipes
Drug: Glycopyrronium Topical Wipes
Glycopyrronium Topical Wipes
Other Names:
  • DRM04

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 1 - Week 44

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET
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.
Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET
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.
Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Journey Medical Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Lynne Deans, MT, Dermira, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DRM04-HH06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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