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A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar 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: NCT03880266
Recruitment Status : Completed
First Posted : March 19, 2019
Results First Posted : March 15, 2021
Last Update Posted : March 15, 2021
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

Detailed Description:
This is a pilot study assessing the safety and efficacy of glycopyrronium cloth in patients with palmar hyperhidrosis

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 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
Actual Primary Completion Date : May 24, 2019
Actual Study Completion Date : May 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

Arm Intervention/treatment
Active Comparator: Group 1 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
Drug: Glycopyrronium cloth, 2.4%
Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium

Placebo Comparator: Group 1 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
Drug: Vehicle
Pre-saturated 100% polypropylene, nonwoven, fabric cloth

Active Comparator: Group 2 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
Drug: Glycopyrronium cloth, 2.4%
Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium

Placebo Comparator: Group 2 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
Drug: Vehicle
Pre-saturated 100% polypropylene, nonwoven, fabric cloth

Active Comparator: Group 3 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
Drug: Glycopyrronium cloth, 2.4%
Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium

Placebo Comparator: Group 3 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes
Drug: Vehicle
Pre-saturated 100% polypropylene, nonwoven, fabric cloth

Active Comparator: Group 4 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
Drug: Glycopyrronium cloth, 2.4%
Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium

Placebo Comparator: Group 4 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
Drug: Vehicle
Pre-saturated 100% polypropylene, nonwoven, fabric cloth




Primary Outcome Measures :
  1. Mean Change From Baseline to Week 2 in Hand Sweating Severity Score [ Time Frame: Baseline, Week 2 ]
    The Hand Sweat Severity Score is a patient reported outcome, designed to measure the severity of palmar hyperhidrosis [score on a scale from 0 (better) -10 (worse)].


Secondary Outcome Measures :
  1. Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2 [ Time Frame: Baseline, 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 (better), 2, 3, 4 (worse)


  2. Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 [ Time Frame: Baseline, Week 2 ]
    Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; average of the change in the gravimetric measurement of sweat produced at baseline compared with Week 2

  3. Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2 [ Time Frame: Baseline, Week 2 ]
    Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; calculation of percentage difference in sweat production at week 2 compared to baseline sweat production

  4. Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2 [ Time Frame: Baseline, Week 2 ]
    Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; confidence interval represents difference between vehicle and active group



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Hyperhidrosis Disease Severity Scale 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 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


Locations
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United States, California
California Dermatology & Clinical Research Institute
Encinitas, California, United States, 92024
United States, Colorado
Colorado Medical Research Center, Inc.
Denver, Colorado, United States, 80210
United States, Florida
International Dermatology Research, Inc.
Miami, Florida, United States, 33144
United States, Indiana
The Indiana Clinical Trials Center
Plainfield, Indiana, United States, 46168
United States, Missouri
Saint Louis University Dermatology
Saint Louis, Missouri, United States, 63122
United States, Texas
Innovative Dermatology/ ACRC Trials
Plano, Texas, United States, 75024
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Dermira, Inc.
Investigators
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Study Director: Kate Doherty Dermira, Inc.
  Study Documents (Full-Text)

Documents provided by Dermira, Inc.:
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Responsible Party: Dermira, Inc.
ClinicalTrials.gov Identifier: NCT03880266    
Other Study ID Numbers: DRM04-HH10
First Posted: March 19, 2019    Key Record Dates
Results First Posted: March 15, 2021
Last Update Posted: March 15, 2021
Last Verified: February 2021
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