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

Status:	Completed
Healthy:	No
Age Range:	9 - Any
Updated:	10/26/2018
Start Date:	August 2015
End Date:	December 2016

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.

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.

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

We found this trial at

sites

Meridian Clinical Research

Omaha, Nebraska 68134

Principal Investigator: Brandon Essink, MD

Phone: 402-933-6500

from

Omaha, NE

Academic Dermatology Associates

Albuquerque, New Mexico 87106

Principal Investigator: Eduardo Tschen

Phone: 505-247-4220

from

Albuquerque, NM

DermResearch, Inc.

Austin, Texas 78759

Principal Investigator: Janet DuBois, MD

Phone: 512-349-9889

from

Austin, TX

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

Berlin, 10117

Principal Investigator: Alexander Nast

Phone: +49 (0)3045 0518313

from

Berlin,

Skin Care research Inc

Boca Raton, Florida 33486

Principal Investigator: Marta Rendon, MD

Phone: 407-786-9715

from

Boca Raton, FL

Study Protocol, Inc.

Boynton Beach, Florida 33437

Principal Investigator: Joshua Berlin, MD

Phone: 561-739-5252

from

Boynton Beach, FL

Shideler Clinical Research Center

Carmel, Indiana

Principal Investigator: Stephen Shideler, MD

Phone: 317-819-1268

from

Carmel, IN

Dermatology and Laser Center of Charleston, PA

Charleston, Pennsylvania 29414

Principal Investigator: Todd Schlesinger, MD, FAAD

Phone: 843-518-6610

from

Charleston, PA

Charlottesville Medical Research Inc.

Charlottesville, Virginia 22911

Principal Investigator: Anna Magee, MD

Phone: 434-984-2400

from

Charlottesville, VA

J&S Studies

College Station, Texas 77845

Principal Investigator: Terry Jones, MD

Phone: 979-774-5933

from

College Station, TX

Modern Research Associates

Dallas, Texas 75231

Principal Investigator: Jennifer Cather, MD

Phone: 519-576-0768

from

Dallas, TX

Colorado Medical Research Center

Denver, Colorado 80210

Principal Investigator: James Swinehart, MD

Phone: 303-744-7000

from

Denver, CO

Zel Skin and Laser Specialist LLC

Edina, Minnesota 55424

Principal Investigator: Brian Zelickson, MD

Phone: 952-746-1017

from

Edina, MN

California Dermatology and Clinical Research Institute

Encinitas, California 92024

Principal Investigator: Stacy Smith, MD

Phone: 760-203-3839

from

Encinitas, CA

Rivergate Dermatology Research Center

Goodlettsville, Tennessee 37072

Principal Investigator: Keith Loven, MD, CPI

Phone: 615-859-0900

from

Goodlettsville, TN

The University of Texas Dermatology Clinical Research Center

Houston, Texas 77030

Principal Investigator: Adelaide Hebert, MD

Phone: 713-500-8266

from

Houston, TX

Dermatology Research Associates

Los Angeles, California 90045

Principal Investigator: Howard Sofen, MD

Phone: 310-337-7171

from

Los Angeles, CA

International Dermatology Research, Inc.

Miami, Florida 33144

Principal Investigator: Javier Alonso-Llamazares, MD

Phone: 305-225-0400

from

Miami, FL

Coastal Medical Research Group LLC

Mobile, Alabama 36608

Principal Investigator: Belin Bodie, MD

Phone: 251-414-1984

from

Mobile, AL

Clinical Research Associates

Nashville, Tennessee 37203

Principal Investigator: Stephan Sharp, MD

Phone: 615-329-0197

from

Nashville, TN

Schweiger Dermatology Group

New York, New York 10022

Principal Investigator: Eric Schweiger, MD

Phone: 305-933-6716

from

New York, NY

Virginia Clinical Research, Inc.

Norfolk, Virginia 23507

Principal Investigator: David Pariser, MD

Phone: 757-625-0151

from

Norfolk, VA

Tory Sullivan MD PA

North Miami Beach, Florida 33162

Principal Investigator: Tory Sullivan, MD

Phone: 321-276-4158

from

North Miami Beach, FL

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas 78660

Principal Investigator: Edward Lain, MD, MBA

Phone: 512-279-2545

from

Pflugerville, TX

The Indiana Clinical Trials Center, PC

Plainfield, Indiana 46168

Principal Investigator: Scott Guenthner, MD

Phone: 317-837-6082

from

Plainfield, IN

ACRC Trials

5425 West Spring Creek Parkway
Plano, Texas 75024

Principal Investigator: Seemal Desai, MD, FAAD

Phone: 972-354-1520

from

Plano, TX

Oregon Dermatology & Research Center

Portland, Oregon 97210

Principal Investigator: Phoebe Rich, MD

Phone: 503-226-3376

from

Portland, OR

Skin Search of Rochester, Inc

Rochester, New York 14623

Principal Investigator: John Tu, MD

Phone: 585-697-1818

from

Rochester, NY

Lawrence J. Green, MD, LLC

Rockville, Maryland 20850

Principal Investigator: Lawrence Green, MD

Phone: 301-610-0663

from

Rockville, MD

Northwest Arkansas Clinical Trials Center, PLLC

Rogers, Arkansas 72758

Principal Investigator: Cheryl Hull, MD

Phone: 479-876-8205

from

Rogers, AR

MediSearch Clinical Trials

1419 Village Drive
Saint Joseph, Missouri 64506

from

Saint Joseph, MO

St Louis University Dermatology

3660 Vista Avenue
Saint Louis, Missouri 63104

from

Saint Louis, MO

Dermatology Research Center

Salt Lake City, Utah 84124

Principal Investigator: Leonard Swinyer, MD

Phone: 801-269-0135

from

Salt Lake City, UT

Texas Dermatology and Laser Specialists

San Antonio, Texas 78218

Principal Investigator: Emily Becker, MD

Phone: 210-829-5180

from

San Antonio, TX

Therapeutics Clinical Research

San Diego, California 92123

Principal Investigator: Neal Bhatia, MD

Phone: 858-571-6800

from

San Diego, CA

Clinical Science Institute

Santa Monica, California 90404

Principal Investigator: Paul Yamauchi, MD, PhD

Phone: 310-828-8887

from

Santa Monica, CA

DBA Dermatology Associates

Seattle, Washington 98101

Principal Investigator: Peter Jenkin, MD

Phone: 206-315-0371

from

Seattle, WA

Premier Clinical Research

Spokane, Washington 99204

Principal Investigator: William Werschler, MD

Phone: 509-343-3710

from

Spokane, WA

Jordan Valley Dermatology Center

West Jordan, Utah 84088

Principal Investigator: Douglass Forsha, MD

Phone: 801-316-0266

from

West Jordan, UT

Research Institute of the Southeast

West Palm Beach, Florida 33401

Principal Investigator: Kenneth Beer, MD

Phone: 561-655-9055

from

West Palm Beach, FL

Prairie Health and Wellness

Wichita, Kansas 67226

Principal Investigator: Jeffrey Davis, MD

Phone: 316-425-6333

from

Wichita, KS

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

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

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