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CompletedNCT02129660Updated Sep 17, 2025Results posted

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

A Phase 2 interventional study of Dose 1 of glycopyrrolate, 2.0% QD and Dose 2 of glycopyrrolate, 3.0% QD in Hyperhidrosis, sponsored by Journey Medical Corporation. Completed at 15 sites in 2 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-09-17.

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

Phase
Phase 2
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

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 105 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 to 99 Years
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.
  • 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

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 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 abnormalities in laboratory values.
  • Subjects with a positive Hepatitis or . 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 deemed clinically significant by the Investigator.
  • History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter. History of other supraventricular tachycardia
Terms in these criteria, in plain language(5)

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.

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.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

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.

05

Study design

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

Study arms

  • Experimental
    Dose 1 of glycopyrrolate, 2.0% QD

    glycopyrrolate Topical Wipes

    Drug: Dose 1 of glycopyrrolate, 2.0% QD

  • Experimental
    Dose 2 of glycopyrrolate, 3.0% QD

    glycopyrrolate Topical Wipes

    Drug: Dose 2 of glycopyrrolate, 3.0% QD

  • Active comparator
    Dose 1 of glycopyrronium, 2.5% QD

    glycopyrronium Topical Wipes

    Drug: Dose 1 of glycopyrronium, 2.5% QD

  • Active comparator
    Dose 2 of glycopyrronium, 3.75% QD

    glycopyrronium Topical Wipes

    Drug: Dose 2 of glycopyrronium, 3.75% QD

  • Placebo comparator
    Vehicle

    Vehicle Topical Wipes

    Other: Vehicle

Interventions

  • DrugDose 1 of glycopyrrolate, 2.0% QD

    Dose 1 of glycopyrrolate Topical Wipes

    Also known as: DRM04B

  • DrugDose 2 of glycopyrrolate, 3.0% QD

    Dose 2 of glycopyrrolate Topical Wipes

    Also known as: DRM04B

  • DrugDose 1 of glycopyrronium, 2.5% QD

    Dose 1 of glycopyrronium Topical Wipes

    Also known as: DRM04

  • DrugDose 2 of glycopyrronium, 3.75% QD

    Dose 2 of glycopyrronium Topical Wipes

    Also known as: DRM04

  • OtherVehicle

    Vehicle Topical Wipes

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/ET

  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

    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

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

    Time frame: Baseline - Week 6

Secondary outcomes

  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

07

Results

Posted Sep 4, 2018

Participant flow

Participant flow — Overall Study
MilestoneDose 1 of GlycopyrrolateDose 2 of GlycopyrrolateDose 1 of GlycopyrroniumDose 2 of GlycopyrroniumVehicle
Started2120222022
Completed1920212020
Not completed20102

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/ET
Reported as:
Count of participants · Participants
Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4
ParticipantsDose 1 of GlycopyrrolateDose 2 of GlycopyrrolateDose 1 of GlycopyrroniumDose 2 of GlycopyrroniumVehicle
Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 410109106
PrimaryPercentage 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
ParticipantsDose 1 of GlycopyrrolateDose 2 of GlycopyrrolateDose 1 of GlycopyrroniumDose 2 of GlycopyrroniumVehicle
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 41617151412
PrimaryPercentage 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
ParticipantsDose 1 of GlycopyrrolateDose 2 of GlycopyrrolateDose 1 of GlycopyrroniumDose 2 of GlycopyrroniumVehicle
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 61916171313
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 minDose 1 of GlycopyrrolateDose 2 of GlycopyrrolateDose 1 of GlycopyrroniumDose 2 of GlycopyrroniumVehicle
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 4-104.20 ± 73.73-58.27 ± 31.00-105.28 ± 95.83-72.69 ± 82.48-53.85 ± 70.65
PrimaryAbsolute 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 minDose 1 of GlycopyrrolateDose 2 of GlycopyrrolateDose 1 of GlycopyrroniumDose 2 of GlycopyrroniumVehicle
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6-92.20 ± 74.87-44.37 ± 40.92-96.98 ± 103.38-66.17 ± 78.96-71.06 ± 64.82
SecondaryPercentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4
Time frame:
Baseline - Week 4
Reported as:
Count of participants · Participants
Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4
ParticipantsDose 1 of GlycopyrrolateDose 2 of GlycopyrrolateDose 1 of GlycopyrroniumDose 2 of GlycopyrroniumVehicle
Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 41916201615
SecondaryPercentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 6
Time frame:
Baseline - Week 6
Reported as:
Count of participants · Participants
Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 6
ParticipantsDose 1 of GlycopyrrolateDose 2 of GlycopyrrolateDose 1 of GlycopyrroniumDose 2 of GlycopyrroniumVehicle
Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 61515171614

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Dose 1 of Glycopyrrolate0/21 (0%)0/21 (0%)4/21 (19%)
Dose 2 of Glycopyrrolate0/20 (0%)0/20 (0%)8/20 (40%)
Dose 1 of Glycopyrronium0/22 (0%)0/22 (0%)11/22 (50%)
Dose 2 of Glycopyrronium0/20 (0%)0/20 (0%)10/20 (50%)
Vehicle0/21 (0%)0/21 (0%)6/21 (28.6%)
Most frequent other events
Showing 10 of 32
Most frequent other events
EventDose 1 of GlycopyrrolateDose 2 of GlycopyrrolateDose 1 of GlycopyrroniumDose 2 of GlycopyrroniumVehicle
Dry MouthGastrointestinal disorders3/214/206/225/201/21
Application Site PainGeneral disorders0/211/200/221/205/21
HeadacheNervous system disorders0/210/203/221/200/21
Back painMusculoskeletal and connective tissue disorders1/210/202/220/200/21
ToothacheGastrointestinal disorders0/210/202/220/200/21
Upper Respiratory Tract InfectionInfections and infestations0/210/202/221/200/21
MydriasisEye disorders1/211/201/220/200/21
Urinary retentionRenal and urinary disorders0/210/201/221/200/21
Nasal drynessRespiratory, thoracic and mediastinal disorders0/211/200/221/200/21
Abdominal distensionGastrointestinal disorders0/210/200/221/200/21

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Dose 1 of GlycopyrrolateDose 2 of GlycopyrrolateDose 1 of GlycopyrroniumDose 2 of GlycopyrroniumVehicleTotal
<=18 years011305
Between 18 and 65 years211921162299
>=65 years000101
Sex: Female, Male
Sex: Female, Male(Participants)Dose 1 of GlycopyrrolateDose 2 of GlycopyrrolateDose 1 of GlycopyrroniumDose 2 of GlycopyrroniumVehicleTotal
Female877131348
Male1313157957
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Dose 1 of GlycopyrrolateDose 2 of GlycopyrrolateDose 1 of GlycopyrroniumDose 2 of GlycopyrroniumVehicleTotal
Hispanic or Latino113005
Not Hispanic or Latino2019192022100
Unknown or Not Reported000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Dose 1 of GlycopyrrolateDose 2 of GlycopyrrolateDose 1 of GlycopyrroniumDose 2 of GlycopyrroniumVehicleTotal
American Indian or Alaska Native000000
Asian000000
Native Hawaiian or Other Pacific Islander000000
Black or African American3033211
White182016172091
More than one race003003
Unknown or Not Reported000000
08

Study locations

15 sites
  • California Dermatology & Clinical Research Institute
    Encinitas, California 92024, United States
  • Center For Dermatology Clinical Research
    Fremont, California 94538, United States
  • Olympian Clinical Research
    Tampa, Florida 33609, United States
  • Kenneth R. Beer MD
    West Palm Beach, Florida 33401, United States
  • Shideler Clinical Research Center
    Carmel, Indiana 46032, United States
  • Saint Louis University Dermatology
    St Louis, Missouri 63122, United States
  • Haber Dermatology and Cosmetic Surgery
    Beachwood, Ohio 44122, United States
  • Rivergate Dermatology Clinical Research Center, PLLC
    Goodlettsville, Tennessee 37072, United States
  • DermResearch, Inc
    Austin, Texas 78759, United States
  • Dermatology Research Center, Inc.
    Salt Lake City, Utah 84117, United States
  • Virginia Clinical Research, Inc.
    Norfolk, Virginia 23507, 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
  • Innovaderm Research Inc.
    Montreal, H2K 4L5, Canada
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 Apr 2014, a primary completion of Jan 2015 and a completion of Jan 2015. It does not say whether these dates are actual or estimated.

Results were first posted in Sep 2018, 3 years 8 months 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
Apr 30, 2014
First posted
May 2, 2014
Start
Apr 2014
Primary completionActual
Jan 2015
CompletionActual
Jan 2015
Results delay requested
Oct 22, 2015
Results first posted
Sep 4, 2018
Last update
Sep 17, 2025
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 Sep 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02129660
Lead sponsor
Journey Medical Corporation
Responsible party
Sponsor
First posted
May 2, 2014
Start date
Apr 2014
Primary completion
Jan 2015
Completion
Jan 2015
Results posted
Sep 4, 2018
Last update
Sep 17, 2025

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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