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Trial record 53 of 168 for:    "Sweat Gland Disease"

A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis

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ClinicalTrials.gov Identifier: NCT02016885
Recruitment Status : Completed
First Posted : December 20, 2013
Results First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Dermira, Inc.

Tracking Information
First Submitted Date  ICMJE December 16, 2013
First Posted Date  ICMJE December 20, 2013
Results First Submitted Date  ICMJE July 17, 2018
Results First Posted Date  ICMJE September 13, 2018
Last Update Posted Date September 13, 2018
Study Start Date  ICMJE November 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2018)
  • Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4 [ Time Frame: Baseline - Week 4 ]
    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)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
  • Proportion of subjects who have a minimum 2-grade improvement in HDSS from baseline. [ Time Frame: Week 4 ]
    Not provided
  • Absolute change in the gravimetrically measured sweat production. [ Time Frame: Week 4 ]
    Not provided
Change History Complete list of historical versions of study NCT02016885 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2018)
  • Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4 [ Time Frame: Baseline - Week 4 ]
  • Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6 [ Time Frame: Baseline - Week 6 ]
  • Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6 [ Time Frame: Baseline - Week 6 ]
  • Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 4 [ Time Frame: Baseline - Week 4 ]
    The DLQI is a ten question questionnaire, used to measure the impact of skin disease on the quality of life of an affected person. The scoring of each question is as follows: Very much (3), A lot (2), A little (1), Not at all (0), Not relevant (0). Is calculated by summing the score of each question resulting in a max of 30 and a min of 0. Higher the score the more Quality of life is impaired.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
  • Proportion of subjects who have a minimum 1-grade improvement in HDSS. [ Time Frame: Week 4 ]
    Not provided
  • Absolute change in the gravimetrically measured sweat. [ Time Frame: Week 6 ]
    Not provided.
  • Proportion of subjects who have a minimum 1-grade improvement in HDSS. [ Time Frame: Week 6 ]
    Not provided.
  • Dermatology Life Quality Index (DLQI) [ Time Frame: Week 4 ]
    Not provided.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
Official Title  ICMJE A Phase 2, Randomized, Double-Blind, Vehicle Controlled, Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
Brief Summary The purpose of this study is to evaluate the safety and efficacy of glycopyrrolate compared to vehicle for the treatment of axillary hyperhidrosis.
Detailed Description

This is a randomized, vehicle controlled, dose-ranging study enrolling subjects with axillary hyperhidrosis and designed to assess the safety and efficacy of four doses of glycopyrrolate compared to vehicle. There are 5 arms in this study.

Efficacy will be assessed through the Hyperhidrosis Disease Severity Score (HDSS), Dermatology Life Quality Index (DLQI) and a gravimetric assessment of sweat production.

Safety will be assessed, at specified times during the study, through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.

PK samples will be taken from 20 to 30 subjects participating in the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hyperhidrosis
Intervention  ICMJE
  • Drug: glycopyrrolate, 1.0%
    glycopyrrolate Topical Wipes, 1.0%
    Other Name: DRM04B
  • Drug: glycopyrrolate, 2.0%
    glycopyrrolate Topical Wipes, 2.0%
    Other Name: DRM04B
  • Drug: glycopyrrolate, 3.0%
    glycopyrrolate Topical Wipes, 3.0%
    Other Name: DRM04B
  • Drug: glycopyrrolate, 4.0%
    glycopyrrolate Topical Wipes, 4.0%
    Other Name: DRM04B
  • Other: Vehicle
    Vehicle Topical Wipes
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: glycopyrrolate, 1.0%
    glycopyrrolate Topical Wipes, 1.0%
    Intervention: Drug: glycopyrrolate, 1.0%
  • Experimental: glycopyrrolate, 2.0%
    glycopyrrolate Topical Wipes, 2.0%
    Intervention: Drug: glycopyrrolate, 2.0%
  • Experimental: glycopyrrolate, 3.0%
    glycopyrrolate Topical Wipes, 3.0%
    Intervention: Drug: glycopyrrolate, 3.0%
  • Experimental: glycopyrrolate, 4.0%
    glycopyrrolate Topical Wipes, 4.0%
    Intervention: Drug: glycopyrrolate, 4.0%
  • Placebo Comparator: Vehicle
    Vehicle Topical Wipes
    Intervention: Other: Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 2, 2014)
198
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2013)
200
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, 18 years of age or older.
  • Primary, axillary hyperhidrosis of at least 6 months duration.
  • A Hyperhidrosis Disease Severity Score (HDSS) of 3or 4.
  • A gravimetric measurement of sweat production of at least 50 mg over 5 minutes in each axilla (total of 100 mg) while at rest at room temperature.
  • Male or non-pregnant, non-lactating females.

Exclusion Criteria:

  • Prior surgical procedure for hyperhidrosis.
  • Any prior treatment with an axillary anti-hyperhidrosis medical device (approved or investigational)
  • Prior treatment with botulinum toxin for axillary hyperhidrosis within 1 year.
  • Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis. Treatment with psychotherapeutic medications for less than 4 months prior to study enrollment. - Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks prior to enrollment.
  • Prior axillary treatment with axillary iontophoresis within 4 weeks.
  • Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
  • Known history of a condition that may cause secondary hyperhidrosis.
  • Known history of Sjögren's syndrome or Sicca syndrome.
  • Abnormal findings on screening ECG deemed clinically significant by the Investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02016885
Other Study ID Numbers  ICMJE DRM04-HH01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dermira, Inc.
Study Sponsor  ICMJE Dermira, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lynne M Deans, MT Dermira, Inc.
PRS Account Dermira, Inc.
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP