HyperhidrosisPhase 2NCT02129660

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

A Phase 2 study testing Dose 1 of glycopyrrolate, 2.0% QD, Dose 2 of glycopyrrolate, 3.0% QD and Dose 1 of glycopyrronium, 2.5% QD in people with Hyperhidrosis, run by Journey Medical Corporation at 15 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Hyperhidrosis
What is being tested?: Dose 1 of glycopyrrolate, 2.0% QD, Dose 2 of glycopyrrolate, 3.0% QD and Dose 1 of glycopyrronium, 2.5% QD
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 105 participants
Where: 15 sitesin 2 countries
Study dates: Apr 2014to Jan 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 21Show fewer

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

Trial locations and contacts

15 sites in 2 countries.

Country

City, postcode or hospital

15 sites in 2 countries

United States14 sites

DermResearch, Inc
Austin, Texas, 78759
Haber Dermatology and Cosmetic Surgery
Beachwood, Ohio, 44122
Shideler Clinical Research Center
Carmel, Indiana, 46032
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Center For Dermatology Clinical Research
Fremont, California, 94538
Rivergate Dermatology Clinical Research Center, PLLC
Goodlettsville, Tennessee, 37072
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84117
Dermatology Associates
Seattle, Washington, 98101
Women's Clinical Research Center
Seattle, Washington, 98105
Premier Clinical Research
Spokane, Washington, 99204
Saint Louis University Dermatology
St Louis, Missouri, 63122
Olympian Clinical Research
Tampa, Florida, 33609
Kenneth R. Beer MD
West Palm Beach, Florida, 33401

Other trials in United States

Canada1 site

Innovaderm Research Inc.
Montreal, H2K 4L5

Other trials in Canada

About this study

Official title: A Phase 2, Randomized, Double-Blind Vehicle-Controlled Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis

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.

Conditions: Hyperhidrosis
Being tested: Dose 1 of glycopyrrolate, 2.0% QD, Dose 2 of glycopyrrolate, 3.0% QD, Dose 1 of glycopyrronium, 2.5% QD, Dose 2 of glycopyrronium, 3.75% QD, Vehicle
Medical subject headings: Hyperhidrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dose 1 of glycopyrrolate, 2.0% QDDrug
Also called DRM04B
Dose 1 of glycopyrrolate Topical Wipes
Dose 2 of glycopyrrolate, 3.0% QDDrug
Also called DRM04B
Dose 2 of glycopyrrolate Topical Wipes
Dose 1 of glycopyrronium, 2.5% QDDrug
Also called DRM04
Dose 1 of glycopyrronium Topical Wipes
Dose 2 of glycopyrronium, 3.75% QDDrug
Also called DRM04
Dose 2 of glycopyrronium Topical Wipes
VehicleOther
Vehicle Topical Wipes

Study groups in NCT02129660
Study group	Role	What they receive
Dose 1 of glycopyrrolate, 2.0% QD	Experimental	glycopyrrolate Topical Wipes Receives: Drug: Dose 1 of glycopyrrolate, 2.0% QD
Dose 2 of glycopyrrolate, 3.0% QD	Experimental	glycopyrrolate Topical Wipes Receives: Drug: Dose 2 of glycopyrrolate, 3.0% QD
Dose 1 of glycopyrronium, 2.5% QD	Active comparator	glycopyrronium Topical Wipes Receives: Drug: Dose 1 of glycopyrronium, 2.5% QD
Dose 2 of glycopyrronium, 3.75% QD	Active comparator	glycopyrronium Topical Wipes Receives: Drug: Dose 2 of glycopyrronium, 3.75% QD
Vehicle	Placebo comparator	Vehicle Topical Wipes Receives: Other: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Baseline - Week 4/ET
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4
Measured: Baseline - Week 4
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6
Measured: Baseline - Week 6
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.
Measured: Baseline - Week 4
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6
Measured: Baseline - Week 6

Secondary outcomes (2)

Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4
Measured: Baseline - Week 4
Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 6
Measured: Baseline - Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Jan 2015

First posted2 May 2014 (estimated)
Study startApr 2014
Primary completionJan 2015
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HyperhidrosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02129660
Sponsor's protocol ID: DRM04-HH02
Status last verified: Sep 2025
First submitted: 30 Apr 2014
Last updated: 17 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hyperhidrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-Blind Vehicle-Controlled Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis
ClinicalTrials.gov ID: NCT02129660
Acronym / sponsor ID: DRM04-HH02
Conditions: Hyperhidrosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: Journey Medical CorporationIndustry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 2 May 2014 (estimated)
Results: Posted 4 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Dose 1 of glycopyrrolate, 2.0% QD	Experimental	Drug: Dose 1 of glycopyrrolate, 2.0% QDglycopyrrolate Topical Wipes
Dose 2 of glycopyrrolate, 3.0% QD	Experimental	Drug: Dose 2 of glycopyrrolate, 3.0% QDglycopyrrolate Topical Wipes
Dose 1 of glycopyrronium, 2.5% QD	Active comparator	Drug: Dose 1 of glycopyrronium, 2.5% QDglycopyrronium Topical Wipes
Dose 2 of glycopyrronium, 3.75% QD	Active comparator	Drug: Dose 2 of glycopyrronium, 3.75% QDglycopyrronium Topical Wipes
Vehicle	Placebo comparator	Other: VehicleVehicle Topical Wipes

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (21 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dose 1 of glycopyrrolate, 2.0% QDAlso: DRM04BDose 1 of glycopyrrolate Topical Wipes	Drug	Dose 1 of glycopyrrolate, 2.0% QD
Dose 2 of glycopyrrolate, 3.0% QDAlso: DRM04BDose 2 of glycopyrrolate Topical Wipes	Drug	Dose 2 of glycopyrrolate, 3.0% QD
Dose 1 of glycopyrronium, 2.5% QDAlso: DRM04Dose 1 of glycopyrronium Topical Wipes	Drug	Dose 1 of glycopyrronium, 2.5% QD
Dose 2 of glycopyrronium, 3.75% QDAlso: DRM04Dose 2 of glycopyrronium Topical Wipes	Drug	Dose 2 of glycopyrronium, 3.75% QD
VehicleVehicle Topical Wipes	Other	Vehicle

Primary outcome

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

2 secondary outcomes

Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4
Time frame: Baseline - Week 4
Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 6
Time frame: Baseline - Week 6

Results and safety

Results posted to the registry on 4 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose 1 of Glycopyrrolate	21	19
Dose 2 of Glycopyrrolate	20	20
Dose 1 of Glycopyrronium	22	21
Dose 2 of Glycopyrronium	20	20
Vehicle	22	20

Primary outcome: Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4

Time frame: Baseline - Week 4/ET. Count of participants. Unit: Participants

Measure	Dose 1 of Glycopyrrolate n = 21	Dose 2 of Glycopyrrolate n = 20	Dose 1 of Glycopyrronium n = 22	Dose 2 of Glycopyrronium n = 20	Vehicle n = 22
Value	10	10	9	10	6

Population analysed: Participant

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

Time frame: Baseline - Week 4. Count of participants. Unit: Participants

Measure	Dose 1 of Glycopyrrolate n = 21	Dose 2 of Glycopyrrolate n = 20	Dose 1 of Glycopyrronium n = 22	Dose 2 of Glycopyrronium n = 20	Vehicle n = 22
Value	16	17	15	14	12

Population analysed: Participant

Primary outcome: Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6

Time frame: Baseline - Week 6. Count of participants. Unit: Participants

Measure	Dose 1 of Glycopyrrolate n = 21	Dose 2 of Glycopyrrolate n = 20	Dose 1 of Glycopyrronium n = 22	Dose 2 of Glycopyrronium n = 20	Vehicle n = 22
Value	19	16	17	13	13

Population analysed: Participant

Primary outcome: Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 4

Time frame: Baseline - Week 4. Mean (Standard Deviation). Unit: mg/5 min

Measure	Dose 1 of Glycopyrrolate n = 21	Dose 2 of Glycopyrrolate n = 20	Dose 1 of Glycopyrronium n = 22	Dose 2 of Glycopyrronium n = 20	Vehicle n = 22
Value	-104.20 (73.73)	-58.27 (31.00)	-105.28 (95.83)	-72.69 (82.48)	-53.85 (70.65)

Population analysed: Participant

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dose 1 of Glycopyrrolate	0 of 21 (0%)	4 of 21 (19%)	0 of 21
Dose 2 of Glycopyrrolate	0 of 20 (0%)	8 of 20 (40%)	0 of 20
Dose 1 of Glycopyrronium	0 of 22 (0%)	11 of 22 (50%)	0 of 22
Dose 2 of Glycopyrronium	0 of 20 (0%)	10 of 20 (50%)	0 of 20
Vehicle	0 of 21 (0%)	6 of 21 (28.6%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33433785Pariser 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lynne M. Deans, MT study director

Dermira, Inc.

15 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4 (time frame: Baseline - Week 4/ET). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02129660, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.