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CompletedNCT02016885Updated Aug 25, 2021Results posted

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

A Phase 2 interventional study of glycopyrrolate, 1.0% and glycopyrrolate, 2.0% in Hyperhidrosis, sponsored by Journey Medical Corporation. Completed at 21 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-25.

Sponsored by Journey Medical Corporation · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
198
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and efficacy of glycopyrrolate compared to vehicle for the treatment of axillary hyperhidrosis.

Read the 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.

02

Conditions studied

  • Hyperhidrosis

Browse trials for

03

In context

Hyperhidrosis

111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.

This study's enrollment of 198 is above the median of 50 across 99 interventional studies indexed under Hyperhidrosis.

Browse Hyperhidrosis studies →

Lead sponsor

Journey Medical Corporation is the lead sponsor of 10 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Prior surgical procedure for hyperhidrosis.
  • Any prior treatment with an axillary anti-hyperhidrosis medical device (approved or )
  • 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 deemed by the Investigator.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
198 participants (actual)

Study arms

  • Experimental
    glycopyrrolate, 1.0%

    glycopyrrolate Topical Wipes, 1.0%

    Drug: glycopyrrolate, 1.0%

  • Experimental
    glycopyrrolate, 2.0%

    glycopyrrolate Topical Wipes, 2.0%

    Drug: glycopyrrolate, 2.0%

  • Experimental
    glycopyrrolate, 3.0%

    glycopyrrolate Topical Wipes, 3.0%

    Drug: glycopyrrolate, 3.0%

  • Experimental
    glycopyrrolate, 4.0%

    glycopyrrolate Topical Wipes, 4.0%

    Drug: glycopyrrolate, 4.0%

  • Placebo comparator
    Vehicle

    Vehicle Topical Wipes

    Other: Vehicle

Interventions

06

What researchers measure

Primary outcomes

  1. Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at 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)

    Time frame: Baseline - Week 4

  2. Absolute Change in the Gravimetrically Measured Sweat Production 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.

    Time frame: Baseline - Week 4

Secondary outcomes

  1. Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4

    Time frame: Baseline - Week 4

  2. Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6

    Time frame: Baseline - Week 6

  3. Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6

    Time frame: Baseline - Week 6

  4. Change in Dermatology Life Quality Index (DLQI) From Baseline at 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.

    Time frame: Baseline - Week 4

07

Results

Posted Sep 13, 2018

Participant flow

Participant flow — Overall Study
MilestoneGlycopyrrolate, 1.0%Glycopyrrolate, 2.0%Glycopyrrolate, 3.0%Glycopyrrolate, 4.0%Vehicle
Started3840404040
Completed3436393039
Not completed441101

Outcome measures

PrimaryPercentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at 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)

Time frame:
Baseline - Week 4
Reported as:
Count of participants · Participants
Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4
ParticipantsGlycopyrrolate, 1.0%Glycopyrrolate, 2.0%Glycopyrrolate, 3.0%Glycopyrrolate, 4.0%Vehicle
Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4142021189
PrimaryAbsolute Change in the Gravimetrically Measured Sweat Production 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.

Time frame:
Baseline - Week 4
Reported as:
Mean · mg/5 min
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 4
mg/5 minGlycopyrrolate, 1.0%Glycopyrrolate, 2.0%Glycopyrrolate, 3.0%Glycopyrrolate, 4.0%Vehicle
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 4-56.63 ± 75.02-67.17 ± 61.26-91.39 ± 71.27-88.40 ± 103.85-55.80 ± 80.65
SecondaryPercentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4
Time frame:
Baseline - Week 4
Reported as:
Count of participants · Participants
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4
ParticipantsGlycopyrrolate, 1.0%Glycopyrrolate, 2.0%Glycopyrrolate, 3.0%Glycopyrrolate, 4.0%Vehicle
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 42730352528
SecondaryAbsolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6
Time frame:
Baseline - Week 6
Reported as:
Mean · mg/5 min
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6
mg/5 minGlycopyrrolate, 1.0%Glycopyrrolate, 2.0%Glycopyrrolate, 3.0%Glycopyrrolate, 4.0%Vehicle
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6-32.08 ± 68.55-51.36 ± 52.30-72.23 ± 64.21-57.15 ± 165.66-55.14 ± 56.92
SecondaryPercentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6
Time frame:
Baseline - Week 6
Reported as:
Count of participants · Participants
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6
ParticipantsGlycopyrrolate, 1.0%Glycopyrrolate, 2.0%Glycopyrrolate, 3.0%Glycopyrrolate, 4.0%Vehicle
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 62427292325
SecondaryChange in Dermatology Life Quality Index (DLQI) From Baseline at 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.

Time frame:
Baseline - Week 4
Reported as:
Mean · scores on a scale
Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 4
scores on a scaleGlycopyrrolate, 1.0%Glycopyrrolate, 2.0%Glycopyrrolate, 3.0%Glycopyrrolate, 4.0%Vehicle
Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 4-6.2 ± 6.0-6.6 ± 4.9-7.0 ± 5.1-5.9 ± 4.7-3.8 ± 4.6

Adverse events

Collected over 6 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Glycopyrrolate, 1.0%0/36 (0%)0/36 (0%)9/36 (25%)
Glycopyrrolate, 2.0%0/39 (0%)0/39 (0%)17/39 (43.6%)
Glycopyrrolate, 3.0%0/40 (0%)1/40 (2.5%)18/40 (45%)
Glycopyrrolate, 4.0%0/40 (0%)0/40 (0%)23/40 (57.5%)
Vehicle0/39 (0%)0/39 (0%)10/39 (25.6%)
Most frequent serious events
Most frequent serious events
EventGlycopyrrolate, 1.0%Glycopyrrolate, 2.0%Glycopyrrolate, 3.0%Glycopyrrolate, 4.0%Vehicle
Malignant melanoma in situNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/360/391/400/400/39
Most frequent other events
Showing 10 of 16
Most frequent other events
EventGlycopyrrolate, 1.0%Glycopyrrolate, 2.0%Glycopyrrolate, 3.0%Glycopyrrolate, 4.0%Vehicle
Dry MouthGastrointestinal disorders5/369/3914/4015/405/39
NasopharyngitisInfections and infestations0/364/392/402/402/39
Vision blurredEye disorders0/362/391/404/400/39
Upper respiratory tract infectionInfections and infestations2/361/393/401/403/39
DysuriaRenal and urinary disorders0/360/391/403/400/39
Urinary retentionRenal and urinary disorders0/361/390/403/400/39
Dry skinSkin and subcutaneous tissue disorders0/362/393/402/400/39
MydriasisEye disorders2/361/390/401/400/39
SinusitisInfections and infestations0/360/390/401/402/39
Nasal drynessRespiratory, thoracic and mediastinal disorders0/362/391/402/400/39

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Glycopyrrolate, 1.0%Glycopyrrolate, 2.0%Glycopyrrolate, 3.0%Glycopyrrolate, 4.0%VehicleTotal
<=18 years220105
Between 18 and 65 years3636403938189
>=65 years020024
Sex: Female, Male
Sex: Female, Male(Participants)Glycopyrrolate, 1.0%Glycopyrrolate, 2.0%Glycopyrrolate, 3.0%Glycopyrrolate, 4.0%VehicleTotal
Female162117232198
Male2219231719100
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Glycopyrrolate, 1.0%Glycopyrrolate, 2.0%Glycopyrrolate, 3.0%Glycopyrrolate, 4.0%VehicleTotal
Hispanic or Latino4832421
Not Hispanic or Latino3432373836177
Unknown or Not Reported000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Glycopyrrolate, 1.0%Glycopyrrolate, 2.0%Glycopyrrolate, 3.0%Glycopyrrolate, 4.0%VehicleTotal
American Indian or Alaska Native001001
Asian011103
Native Hawaiian or Other Pacific Islander000000
Black or African American4423316
White3434343037169
More than one race012609
Unknown or Not Reported000000
08

Study locations

21 sites
  • Burke Pharmaceutical Research
    Hot Springs, Arkansas 71913, United States
  • Gary M. Petrus, MD, PA
    Little Rock, Arkansas 72202, United States
  • California Dermatology & Clinical Research Institute
    Encinitas, California 92024, United States
  • Center For Dermatology Clinical Research
    Fremont, California 94538, United States
  • Florida Academic Dermatology Center
    Miami, Florida 33136, United States
  • Kenneth R. Beer, MD, PA
    West Palm Beach, Florida 33401, United States
  • Shideler Clinical Research Center
    Carmel, Indiana 46032, United States
  • Cypress Medical Research Center, LLC
    Wichita, Kansas 67226, United States
  • Minnesota Clinical Study Center
    Fridley, Minnesota 55432, United States
  • Saint Louis University Dermatology
    Saint Louis, Missouri 63122, United States
  • Skin Specialists, PC
    Omaha, Nebraska 68144, United States
  • The Dermatology Group, PC
    Verona, New Jersey 07044, United States
  • Oregon Medical Research Center
    Portland, Oregon 97223, United States
  • J&S Studies, Inc.
    College Station, Texas 77845, United States
  • Clinical Trials of Texas, Inc.
    San Antonio, Texas 78229, United States
  • Dermatology Research Center, Inc.
    Salt Lake City, Utah 84117, United States
  • Virginia Clinical Research, Inc.
    Norfolk, Virginia 23507, United States
  • Westend Dermatology Associates
    Richmond, Virginia 23233, United States
  • Dermatology Associates
    Seattle, Washington 98101, United States
  • Women's Clinical Research Center
    Seattle, Washington 98105, United States
  • Premier Clinical Research
    Spokane, Washington 99204, United States
09

References and documents

Publications

  • Pariser DM, Lain EL, Mamelok RD, Drew J, Mould DR. Limited Systemic Exposure with Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis. Clin Pharmacokinet. 2021 May;60(5):665-676. doi: 10.1007/s40262-020-00975-y. Epub 2021 Jan 12. PubMed 33433785 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2013, a primary completion of Sep 2014 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.

Results were first posted in Sep 2018, 4 years after primary completion. A results delay was requested in Oct 2015.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 16, 2013
First posted
Dec 20, 2013
Start
Nov 2013
Primary completionActual
Sep 2014
CompletionActual
Sep 2014
Results delay requested
Oct 22, 2015
Results first posted
Sep 13, 2018
Last update
Aug 25, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02016885
Lead sponsor
Journey Medical Corporation
Responsible party
Sponsor
First posted
Dec 20, 2013
Start date
Nov 2013
Primary completion
Sep 2014
Completion
Sep 2014
Results posted
Sep 13, 2018
Last update
Aug 25, 2021

Study contacts

Lynne M Deans, MT
study director · Dermira, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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