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Trial record 48 of 166 for:    "Sweat Gland Disease"

Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis

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ClinicalTrials.gov Identifier: NCT02129660
Recruitment Status : Completed
First Posted : May 2, 2014
Results First Posted : September 3, 2018
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Dermira, Inc.

Brief Summary:
The purpose of the study is to assess the safety of 2 doses of glycopyrrolate compared to 2 doses of glycopyrronium and vehicle (5 treatment arms) for the treatment of axillary hyperhidrosis when applied once daily for 4 weeks followed by a 2-week post-dose period.

Condition or disease Intervention/treatment Phase
Hyperhidrosis Drug: Dose 1 of glycopyrrolate, 2.0% QD Drug: Dose 2 of glycopyrrolate, 3.0% QD Drug: Dose 1 of glycopyrronium, 2.5% QD Drug: Dose 2 of glycopyrronium, 3.75% QD Other: Vehicle Phase 2

Detailed Description:

This is a randomized, double-blind, vehicle controlled, parallel group, comparator study designed to assess the safety, efficacy and pharmacokinetics of two doses of glycopyrrolate compared to two doses of glycopyrronium compared to vehicle, 5 treatment arms.

Efficacy will be assessed through gravimetric assessment of sweat production using Patient Reported Outcome and the Hyperhidrosis Disease Severity Score (HDSS).

Safety will be assessed through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.

PK blood samples will be taken study subjects.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind Vehicle-Controlled Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis
Study Start Date : April 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose 1 of glycopyrrolate, 2.0% QD
glycopyrrolate Topical Wipes
Drug: Dose 1 of glycopyrrolate, 2.0% QD
Dose 1 of glycopyrrolate Topical Wipes
Other Name: DRM04B

Experimental: Dose 2 of glycopyrrolate, 3.0% QD
glycopyrrolate Topical Wipes
Drug: Dose 2 of glycopyrrolate, 3.0% QD
Dose 2 of glycopyrrolate Topical Wipes
Other Name: DRM04B

Active Comparator: Dose 1 of glycopyrronium, 2.5% QD
glycopyrronium Topical Wipes
Drug: Dose 1 of glycopyrronium, 2.5% QD
Dose 1 of glycopyrronium Topical Wipes
Other Name: DRM04

Active Comparator: Dose 2 of glycopyrronium, 3.75% QD
glycopyrronium Topical Wipes
Drug: Dose 2 of glycopyrronium, 3.75% QD
Dose 2 of glycopyrronium Topical Wipes
Other Name: DRM04

Placebo Comparator: Vehicle
Vehicle Topical Wipes
Other: Vehicle
Vehicle Topical Wipes




Primary Outcome Measures :
  1. Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4 [ Time Frame: Baseline - Week 4/ET ]

    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. Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4 [ Time Frame: Baseline - Week 4 ]
  3. Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6 [ Time Frame: Baseline - Week 6 ]
  4. Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 4 [ Time Frame: Baseline - Week 4 ]
    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.

  5. Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6 [ Time Frame: Baseline - Week 6 ]

Secondary Outcome Measures :
  1. Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4 [ Time Frame: Baseline - Week 4 ]
  2. Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 6 [ Time Frame: Baseline - Week 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, 18 years of age or older.
  • Primary, axillary hyperhidrosis of at least 6 months duration.
  • Hyperhidrosis Disease Severity Score (HDSS) of 3 or 4 at baseline.
  • For each axilla, a baseline gravimetric measurement of sweat production of at least 50 mg over 5 minutes, while at rest, at room temperature.
  • Male or non-pregnant, non-lactating females.

Exclusion Criteria:

  • Current pregnancy or lactation.
  • Prior surgical procedure for hyperhidrosis.
  • Any prior axillary treatment with an anti-hyperhidrosis medical device
  • Any prior treatment with an investigational drug within 4 weeks prior to Baseline/Day 1 or within 5 elimination half lives of the active agent, whichever is longer or 6 weeks if the elimination half life is not known. Experimental devices are excluded without the approval of the Medical Monitor.
  • Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1.
  • Subjects with clinically significant abnormalities in laboratory values.
  • Subjects with a positive Hepatitis or HIV.Hepatitis B surface antibody positive is allowed only if the subject has a history of having received Hepatitis B vaccination and there are no clinically significant abnormalities in screening liver function tests.
  • Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis, within one month prior to Baseline/Day 1.
  • Treatment with psychotherapeutic medications for less than 4 months prior to Baseline/Day 1.
  • Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks of the baseline visit
  • Prior treatment with axillary iontophoresis within 4 weeks of Baseline/Day 1.
  • Any previous IV or oral treatment with the study drug.
  • Prior treatment with the topical study drug in a previous trial.
  • Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
  • Presence of a condition, within 10 years of enrollment, that may cause secondary hyperhidrosis
  • Menopausal women who have had symptoms of menopause such as sweating or flushing within 3 years of the study may not be enrolled.
  • Known history of Sjögren's syndrome or Sicca syndrome.
  • History of glaucoma, inflammatory bowel disease, toxic megacolon, or febrile illness.
  • Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.
  • Abnormal findings on screening ECG deemed clinically significant by the Investigator.
  • History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter. History of other supraventricular tachycardia

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): NCT02129660


Locations
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United States, California
California Dermatology & Clinical Research Institute
Encinitas, California, United States, 92024
Center For Dermatology Clinical Research
Fremont, California, United States, 94538
United States, Florida
Olympian Clinical Research
Tampa, Florida, United States, 33609
Kenneth R. Beer MD
West Palm Beach, Florida, United States, 33401
United States, Indiana
Shideler Clinical Research Center
Carmel, Indiana, United States, 46032
United States, Missouri
Saint Louis University Dermatology
Saint Louis, Missouri, United States, 63122
United States, Ohio
Haber Dermatology and Cosmetic Surgery
Beachwood, Ohio, United States, 44122
United States, Tennessee
Rivergate Dermatology Clinical Research Center, PLLC
Goodlettsville, Tennessee, United States, 37072
United States, Texas
DermResearch, Inc
Austin, Texas, United States, 78759
United States, Utah
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States, 84117
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
United States, Washington
Dermatology Associates
Seattle, Washington, United States, 98101
Women's Clinical Research Center
Seattle, Washington, United States, 98105
Premier Clinical Research
Spokane, Washington, United States, 99204
Canada
Innovaderm Research Inc.
Montreal, Canada, H2K 4L5
Sponsors and Collaborators
Dermira, Inc.
Investigators
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Study Director: Lynne M. Deans, MT Dermira, Inc.

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Responsible Party: Dermira, Inc.
ClinicalTrials.gov Identifier: NCT02129660     History of Changes
Other Study ID Numbers: DRM04-HH02
First Posted: May 2, 2014    Key Record Dates
Results First Posted: September 3, 2018
Last Update Posted: September 3, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Sweat Gland Diseases
Hyperhidrosis
Skin Diseases
Glycopyrrolate
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs