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A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis

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ClinicalTrials.gov Identifier: NCT03880266
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Dermira, Inc.

Brief Summary:
The objective of this study is to assess the efficacy and safety of glycopyrronium cloth, 2.4% when used to treat palmar hyperhidrosis.

Condition or disease Intervention/treatment Phase
Palmar Hyperhidrosis Drug: Glycopyrronium cloth, 2.4% Drug: Vehicle Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
Actual Study Start Date : February 22, 2019
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : November 1, 2019

Arm Intervention/treatment
Experimental: Group 1
Glycopyrronium cloth, 2.4% or vehicle cloth applied to the hands once daily for 14 days (Treatment 1)
Drug: Glycopyrronium cloth, 2.4%
Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium

Drug: Vehicle
Pre-saturated 100% polypropylene, nonwoven, fabric cloth

Experimental: Group 2
Glycopyrronium cloth, 2.4% or vehicle cloth applied to the hands once daily for 14 days (Treatment 2)
Drug: Glycopyrronium cloth, 2.4%
Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium

Drug: Vehicle
Pre-saturated 100% polypropylene, nonwoven, fabric cloth

Experimental: Group 3
Glycopyrronium cloth, 2.4% or vehicle cloth applied to the hands once daily for 14 days (Treatment 3)
Drug: Glycopyrronium cloth, 2.4%
Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium

Drug: Vehicle
Pre-saturated 100% polypropylene, nonwoven, fabric cloth

Experimental: Group 4
Glycopyrronium cloth, 2.4% or vehicle cloth applied to the hands once daily for 14 days (Treatment 4)
Drug: Glycopyrronium cloth, 2.4%
Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium

Drug: Vehicle
Pre-saturated 100% polypropylene, nonwoven, fabric cloth




Primary Outcome Measures :
  1. Mean change from Baseline to Week 2 in the hand sweating severity score. [ Time Frame: From Baseline to Week 2 ]
    The hand sweat severity item is a patient reported outcome, designed to measure the severity of palmar hyperhidrosis.


Secondary Outcome Measures :
  1. Proportion of subjects who have a ≥2 grade improvement in HDSS from baseline at Week 2. [ Time Frame: From Baseline to Week 2 ]

    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.

    1 (Best), 2, 3, 4 (Worst)


  2. Mean absolute change from baseline in gravimetrically-measured sweat production at Week 2. [ Time Frame: Week 2 ]
  3. Percent change from baseline in gravimetrically-measured sweat production at Week 2. [ Time Frame: Week 2 ]
  4. Proportion of subjects who have at least a 50% reduction in gravimetrically-measured sweat production from baseline at Week 2. [ Time Frame: From Baseline to Week 2 ]


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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:

  1. Signed informed consent and assent (for subjects under legal adult age).
  2. Age ≥9 years.
  3. Primary palmar hyperhidrosis for at least 6 months duration.
  4. Average sweat severity score of ≥4 at Baseline.
  5. HDSS of 3 or 4 at Baseline.
  6. Willing to comply with the protocol. Subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol.
  7. Male or non-pregnant (negative urine pregnancy test in female subjects of child-bearing potential), non-lactating females.

Exclusion Criteria:

  1. Subjects who have taken or are currently taking Qbrexza (glycopyrronium) cloth, 2.4%.
  2. Prior surgical procedure for hyperhidrosis.
  3. Iontophoresis for the palms within 4 weeks of Baseline.
  4. Treatment with botulinum toxin (e.g., Botox®) for palmar hyperhidrosis within 1 year of Baseline.
  5. Open wounds or inflammatory lesions on the hands or, any condition that may alter the barrier function of the skin on the hands.
  6. Secondary palmar hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis (e.g., lymphoma, malaria, severe anxiety not controlled by medication, carcinoid syndrome, substance abuse, hyperthyroidism).
  7. Known history of Sjögren's syndrome or Sicca syndrome.
  8. History of glaucoma, inflammatory bowel disease, toxic megacolon, active febrile illness, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis or myasthenia gravis.
  9. Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.

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): NCT03880266


Contacts
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Contact: Adrienne Vinson 214-630-0288 ext 5026 avinson@medtrials.com

Locations
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United States, California
California Dermatology & Clinical Research Institute Recruiting
Encinitas, California, United States, 92024
United States, Colorado
Colorado Medical Research Center, Inc. Recruiting
Denver, Colorado, United States, 80210
United States, Florida
International Dermatology Research, Inc. Recruiting
Miami, Florida, United States, 33144
United States, Indiana
The Indiana Clinical Trials Center Recruiting
Plainfield, Indiana, United States, 46168
United States, Missouri
Saint Louis University Dermatology Recruiting
Saint Louis, Missouri, United States, 63122
United States, Texas
The University of Texas Health Science Center Houston Not yet recruiting
Houston, Texas, United States, 77030
Innovative Dermatology/ ACRC Trials Recruiting
Plano, Texas, United States, 75024
United States, Virginia
Virginia Clinical Research, Inc. Recruiting
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Dermira, Inc.
Investigators
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Study Director: Janice Drew Dermira, Inc.

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Responsible Party: Dermira, Inc.
ClinicalTrials.gov Identifier: NCT03880266     History of Changes
Other Study ID Numbers: DRM04-HH10
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases