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Trial record 41 of 166 for:    "Sweat Gland Disease"

Study of Glycopyrronium in Axillary Hyperhydrosis

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ClinicalTrials.gov Identifier: NCT02530281
Recruitment Status : Completed
First Posted : August 21, 2015
Results First Posted : August 14, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Dermira, Inc.

Brief Summary:
The study is a randomized, double-blind, vehicle controlled, parallel group study, designed to assess the efficacy and safety of glycopyrronium topical wipes, once daily, compared to vehicle in subjects with axillary hyperhidrosis.

Condition or disease Intervention/treatment Phase
Hyperhidrosis Drug: glycopyrronium Topical Wipes Other: Vehicle Phase 3

Detailed Description:

This is a randomized, double-blind vehicle controlled study to assess the efficacy and safety of glycopyrronium topical wipes compared to vehicle in subjects with axillary hyperhidrosis.

Safety will be assessed through lab tests, ECG, physical exams and vital signs.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 344 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Efficacy and Safety Study of Glycopyrronium in Subjects With Axillary Hyperhydrosis
Study Start Date : July 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: glycopyrronium
glycopyrronium Topical Wipes
Drug: glycopyrronium Topical Wipes
Topical wipes containing glycopyrronium
Other Name: DRM04

Placebo Comparator: Vehicle
glycopyrronium Topical Wipes, Vehicle
Other: Vehicle
Vehicle (placebo) topical wipes




Primary Outcome Measures :
  1. Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of ASDD Item #2 From Baseline at Week 4 [ Time Frame: From Baseline to Week 4 ]

    The Axillary Sweating Daily Diary (ASDD) is a 4-item instrument designed to measure the severity of axillary hyperhidrosis and its impact on daily activities. The 4 Items are:

    1. During the past 24 hours, did you have any underarm sweating? (Yes or No)
    2. During the past 24 hours, how would you rate your underarm sweating at its worst? (0=No sweating at all, 1, 2,…, 10=Worst possible sweating)
    3. During the past 24 hours, to what extent did your underarm sweating impact your activities? (0=Not at all, 1=A little bit, 2=A moderate amount, 3=A great deal and 4=An extreme amount)
    4. During the past 24 hours, how bothered were you by your underarm sweating? (0=Not at all bothered, 1=A little bothered, 2=Moderately bothered, 3=Very bothered, 4=Extremely bothered)

  2. Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 [ Time Frame: From Baseline to 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.

  3. Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 [ Time Frame: From Baseline to Week 4 ]
  4. Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data [ Time Frame: Baseline - Week 4 ]

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

    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. Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4 [ Time Frame: From Baseline to Week 4 ]


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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:

  • Male or female ≥ 9 years of age.
  • Primary, axillary hyperhidrosis of at least 6 months duration
  • Hyperhidrosis Disease Severity Scale (HDSS) of 3 or 4 at Baseline
  • Axillary Sweating Daily Diary (ASDD) ≥ 4 at Baseline
  • Sweat production of at least 50 mg over 5 minutes in each axilla assessed gravimetrically

Exclusion Criteria:

  • Prior surgical procedure for hyperhidrosis.
  • Prior axillary treatment with an anti-hyperhidrosis medical device (approved or investigational).
  • Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1.
  • Previous active treatment in the Dermira DRM04-HH01 or DRM04-HH02 clinical trials.
  • Axillary use of nonprescription antiperspirants within 1 week or prescription antiperspirants within 2 weeks of Baseline.
  • Subjects on new or regimens of psychotherapeutic medications that have changed within 2 months of baseline.
  • Treatment with systemic anticholinergics within 4 weeks of the baseline visit unless dosing has been stable for at least 4 months.
  • Other treatment with glycopyrrolate within 4 weeks prior to Baseline.
  • Secondary axillary hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis.
  • 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.
  • History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter.
  • Other systemic diseases or active uncontrolled infections, or any other condition which, in the judgment of the Investigator, would put the subject at unacceptable risk for participation in the study.

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): NCT02530281


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Sponsors and Collaborators
Dermira, Inc.
Investigators
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Study Director: Lynne M Deans, MT Dermira, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dermira, Inc.
ClinicalTrials.gov Identifier: NCT02530281     History of Changes
Other Study ID Numbers: DRM04-HH04
2015-002052-27 ( EudraCT Number )
First Posted: August 21, 2015    Key Record Dates
Results First Posted: August 14, 2018
Last Update Posted: September 25, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases