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

NCT ID: NCT02553798

Last Updated: 2021-08-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

564 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hyperhidrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glycopyrronium

Glycopyrronium Topical Wipes

Group Type EXPERIMENTAL

Glycopyrronium Topical Wipes

Intervention Type DRUG

Glycopyrronium Topical Wipes

Interventions

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Glycopyrronium Topical Wipes

Glycopyrronium Topical Wipes

Intervention Type DRUG

Other Intervention Names

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DRM04

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Journey Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lynne Deans, MT

Role: STUDY_DIRECTOR

Dermira, Inc.

Locations

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Coastal Medical Research Group LLC

Mobile, Alabama, United States

Site Status

Northwest Arkansas Clinical Trials Center, PLLC

Rogers, Arkansas, United States

Site Status

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Site Status

Dermatology Research Associates

Los Angeles, California, United States

Site Status

Therapeutics Clinical Research

San Diego, California, United States

Site Status

Clinical Science Institute

Santa Monica, California, United States

Site Status

Colorado Medical Research Center, Inc

Denver, Colorado, United States

Site Status

Skin Care Research, Inc.

Boca Raton, Florida, United States

Site Status

Study Protocol, Inc

Boynton Beach, Florida, United States

Site Status

International Dermatology Research, Inc.

Miami, Florida, United States

Site Status

Tory Sullivan, MD

North Miami Beach, Florida, United States

Site Status

Research Institute of the Southeast

West Palm Beach, Florida, United States

Site Status

Shideler Clinical Research Center

Carmel, Indiana, United States

Site Status

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, United States

Site Status

Prairie Health and Wellness

Wichita, Kansas, United States

Site Status

Lawrence J. Green M.D., LLC

Rockville, Maryland, United States

Site Status

Zel Skin & Laser Specialist

Edina, Minnesota, United States

Site Status

MediSearch Clinical Trials

Saint Joseph, Missouri, United States

Site Status

St. Louis University Dermatology

St Louis, Missouri, United States

Site Status

Meridian Clinical Research

Omaha, Nebraska, United States

Site Status

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Site Status

Schweiger Dermatology Group

New York, New York, United States

Site Status

Skin Search of Rochester, Inc

Rochester, New York, United States

Site Status

Oregon Dermatology and Research Center

Portland, Oregon, United States

Site Status

Dermatology and Laser Center of Charleston, PA

Charleston, Pennsylvania, United States

Site Status

Rivergate Dermatology Research Center, PLLC

Goodlettsville, Tennessee, United States

Site Status

Clinical Research Associates, Inc

Nashville, Tennessee, United States

Site Status

DermResearch

Austin, Texas, United States

Site Status

J & S Studies, Inc.

College Station, Texas, United States

Site Status

Modern Research Associates, PLLC

Dallas, Texas, United States

Site Status

The University of Texas Dermatology Clinical Research Center

Houston, Texas, United States

Site Status

Austin Institute for Clinical Research

Pflugerville, Texas, United States

Site Status

ACRC Trials

Plano, Texas, United States

Site Status

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Site Status

Dermatology Research Center, Inc.

Salt Lake City, Utah, United States

Site Status

Jordan Valley Dermatology Center, LLC

West Jordan, Utah, United States

Site Status

Charlottesville Medical Research

Charlottesville, Virginia, United States

Site Status

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Site Status

Dermatology Associates

Seattle, Washington, United States

Site Status

Premier Clinical Research

Spokane, Washington, United States

Site Status

Klinik für Dermatologie, Venerologie und Allergologie Allergie-Centrum-Charité

Berlin, , Germany

Site Status

Pro DERMA im Hautzentrum Dulmen

Dülmen, , Germany

Site Status

Medical Practice and Derma-Study-Center Friedrichshafen GmbH

Friedrichshafen, , Germany

Site Status

SRH Wald-Klinikum Gera GmbH

Gera, , Germany

Site Status

Hautarztpraxis

Glückstadt, , Germany

Site Status

Tagesklinik DermaKiel

Kiel, , Germany

Site Status

Dermatolosche Gemeinschaftspraxis

Mahlow, , Germany

Site Status

Gemeinschaftspraxis Weber & Cranic

Schweinfurt, , Germany

Site Status

Countries

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United States Germany

References

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Glaser DA, Hebert AA, Nast A, Werschler WP, Green L, Mamelok RD, Quiring J, Drew J, Pariser DM. A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis. Am J Clin Dermatol. 2019 Aug;20(4):593-604. doi: 10.1007/s40257-019-00446-6.

Reference Type DERIVED
PMID: 31111409 (View on PubMed)

Other Identifiers

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DRM04-HH06

Identifier Type: -

Identifier Source: org_study_id

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