HyperhidrosisPhase 3NCT02530281

Study of Glycopyrronium in Axillary Hyperhydrosis

A Phase 3 study testing glycopyrronium Topical Wipes in people with Hyperhidrosis, run by Journey Medical Corporation at 31 sites in 2 countries.

Completed

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

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 9 years and older
Conditions the study is for: Hyperhidrosis
What is being tested?: glycopyrronium Topical Wipes
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 344 participants
Where: 31 sitesin 2 countries
Study dates: Jul 2015to Mar 2016
Phase: Phase 3
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 9 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 14Show fewer

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.

Trial locations and contacts

31 sites in 2 countries.

Country

City, postcode or hospital

31 sites in 2 countries

United States21 sites

DermResearch
Austin, Texas, 78759
Skin Care Research, Inc.
Boca Raton, Florida, 33486
Study Protocol, Inc.
Boynton Beach, Florida, 33437
Dermatology and Laser Center
Charleston, South Carolina, 29414
Charlottesville Dermatology Research Center
Charlottesville, Virginia, 22911
J&S Studies
College Station, Texas, 77845
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Rivergate Dermatology Clinical Research Center, PLLC
Goodlettsville, Tennessee, 37072
International Dermatology Research, Inc.
Miami, Florida, 33144
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
Tory Sullivan, M.D., P.A.
North Miami Beach, Florida, 33162
Meridian Clinical Research
Omaha, Nebraska, 68134
Austin Institute for Clinical Research
Pflugerville, Texas, 78860
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
ACRC Trials / Innovative Dermatology
Plano, Texas, 75024
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Therapeutics Clinical Research
San Diego, California, 92123
St. Louis University Dermatology
St Louis, Missouri, 63122
Research Institute of the Southeast
West Palm Beach, Florida, 33401
Prairie Health and Wellness
Wichita, Kansas, 67226

Other trials in United States

Germany10 sites

Klinik fur Dermatologie, Allergologie und Venerologie Allergie-Centrum-Charite
Berlin, 10117
Pro DERMA im Hautzentrum Dulmen
Dülmen, 48249
Medical Practice and Derma Study Center Friedrichshafen GmbH
Friedrichshafen, 88045
SRH Wald-Klinikum Gera GmbH
Gera, 07548
Hautarztpraxis
Glückstadt, 25348
Tagesklinik DermaKiel
Kiel, 24148
Dermatolosche Gemeinschaftspraxis
Mahlow, 15831
Hautarztpraxis
Pinneberg, 25421
Gemeinschaftspraxis Weber & Cranic
Schweinfurt, 97421
Hautarztpraxis
Stuttgart, 70499

Other trials in Germany

About this study

Official title: A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Efficacy and Safety Study of Glycopyrronium in Subjects With Axillary Hyperhydrosis

Read the 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.

Conditions: Hyperhidrosis
Being tested: glycopyrronium Topical Wipes, Vehicle
Medical subject headings: Hyperhidrosis

What participants receive

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

glycopyrronium Topical WipesDrug
Also called DRM04
Topical wipes containing glycopyrronium
VehicleOther
Vehicle (placebo) topical wipes

Study groups in NCT02530281
Study group	Role	What they receive
glycopyrronium	Experimental	glycopyrronium Topical Wipes Receives: Drug: glycopyrronium Topical Wipes
Vehicle	Placebo comparator	glycopyrronium Topical Wipes, Vehicle 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 ≥4-point Improvement in the Weekly Mean Score of ASDD Item #2 From Baseline at 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)
Measured: From Baseline to Week 4
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at 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: From Baseline to Week 4
Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4
Measured: From Baseline to Week 4
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data
Measured: Baseline - Week 4

Secondary outcomes (2)

Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at 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)
Measured: From Baseline to Week 4
Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4
Measured: From Baseline to Week 4

Timeline

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

Jul 2015Mar 2016

First posted21 Aug 2015 (estimated)
Study startJul 2015
Primary completionMar 2016
Study completionMar 2016

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 (3)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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 344 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02530281
Sponsor's protocol ID: DRM04-HH04
Other IDs: 2015-002052-27, 2015
Status last verified: Aug 2021
First submitted: 19 Aug 2015
Last updated: 25 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Hebert AA, Glaser DA, Green L, Hull C, Cather J, Drew J, Gopalan R, Pariser DM. Long-term efficacy and safety of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Post hoc pediatric subgroup analysis from a 44-week open-label extension study. Pediatr Dermatol. 2020 May;37(3):490-497. doi: 10.1111/pde.14135. Epub 2020 Mar 8.
PubMed 32147881
Glaser DA, Hebert AA, Nast A, Werschler WP, Green L, Mamelok RD, Quiring J, Drew J, Pariser DM. A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis. Am J Clin Dermatol. 2019 Aug;20(4):593-604. doi: 10.1007/s40257-019-00446-6.
PubMed 31111409
Pariser DM, Hebert AA, Drew J, Quiring J, Gopalan R, Glaser DA. Topical Glycopyrronium Tosylate for the Treatment of Primary Axillary Hyperhidrosis: Patient-Reported Outcomes from the ATMOS-1 and ATMOS-2 Phase III Randomized Controlled Trials. Am J Clin Dermatol. 2019 Feb;20(1):135-145. doi: 10.1007/s40257-018-0395-0.
PubMed 30378087

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 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Efficacy and Safety Study of Glycopyrronium in Subjects With Axillary Hyperhydrosis
ClinicalTrials.gov ID: NCT02530281
Acronym / sponsor ID: DRM04-HH04
Conditions: Hyperhidrosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 344 participants (actual)
Lead sponsor: Journey Medical CorporationIndustry (pharma, biotech, devices)
Study start: Jul 2015
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 21 Aug 2015 (estimated)
Results: Posted 14 Aug 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

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
glycopyrronium	Experimental	Drug: glycopyrronium Topical Wipesglycopyrronium Topical Wipes
Vehicle	Placebo comparator	Other: Vehicleglycopyrronium Topical Wipes, Vehicle

Who may qualify

Ages: 9 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (14 listed)

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.

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
glycopyrronium Topical WipesAlso: DRM04Topical wipes containing glycopyrronium	Drug	glycopyrronium
VehicleVehicle (placebo) topical wipes	Other	Vehicle

Primary outcome

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

2 secondary outcomes

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
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

Results and safety

Results posted to the registry on 14 Aug 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
Glycopyrronium	229	208
Vehicle	115	112

Primary outcome: 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. Number. Unit: percent of subjects

Measure	Glycopyrronium n = 229	Vehicle n = 115
Value	52.8	28.3

Glycopyrronium vs Vehicle: p <0.001, Cochran-Mantel-Haenszel

Population analysed: Participant

Primary outcome: Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4

Time frame: From Baseline to Week 4. Least squares mean (Standard Deviation). Unit: mg/5 min

Measure	Glycopyrronium n = 229	Vehicle n = 115
Value	-102.00 (176.136)	-100.34 (172.276)

Glycopyrronium vs Vehicle: p =0.065, ANCOVA

Population analysed: Participant

Primary outcome: Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4

Time frame: From Baseline to Week 4. Median (Inter-Quartile Range). Unit: mg/5 min

Measure	Glycopyrronium n = 229	Vehicle n = 115
Value	-80.79 (-148.78 to -40.15)	-65.81 (-105.67 to -27.65)

Glycopyrronium vs Vehicle: p =0.065, ANCOVA

Population analysed: Participant

Primary outcome: Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data

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

Measure	Glycopyrronium n = 220	Vehicle n = 110
Value	-100.56 (98.151)	-88.08 (95.695)

Glycopyrronium vs Vehicle: p =0.001, ANCOVA

Population analysed: Participant

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 35 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Glycopyrronium	1 of 227 (0.4%)	68 of 227 (30%)	0 of 227
Vehicle	0 of 114 (0%)	16 of 114 (14%)	0 of 114

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32147881Hebert AA, Glaser DA, Green L, Hull C, Cather J, Drew J, Gopalan R, Pariser DM. Long-term efficacy and safety of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Post hoc pediatric subgroup analysis from a 44-week open-label extension study. Pediatr Dermatol. 2020 May;37(3):490-497. doi: 10.1111/pde.14135. Epub 2020 Mar 8.
Derived from this study: PubMed 31111409Glaser DA, Hebert AA, Nast A, Werschler WP, Green L, Mamelok RD, Quiring J, Drew J, Pariser DM. A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis. Am J Clin Dermatol. 2019 Aug;20(4):593-604. doi: 10.1007/s40257-019-00446-6.
Derived from this study: PubMed 30378087Pariser DM, Hebert AA, Drew J, Quiring J, Gopalan R, Glaser DA. Topical Glycopyrronium Tosylate for the Treatment of Primary Axillary Hyperhidrosis: Patient-Reported Outcomes from the ATMOS-1 and ATMOS-2 Phase III Randomized Controlled Trials. Am J Clin Dermatol. 2019 Feb;20(1):135-145. doi: 10.1007/s40257-018-0395-0.
Individual participant dataSharing planned: Undecided

Related trials for Hyperhidrosis

RecruitingObservational study
Targeting Nociceptors in Hidradenitis Suppurativa
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20% Alcohol With Steroid Local Anesthetic Technique Versus Steroid Local Anesthetic Technique Only in Stellate Ganglion Injection in Idiopathic Palmar Hyperhydrosis
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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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing glycopyrronium Topical Wipes in people with Hyperhidrosis, run by Journey Medical Corporation at 31 sites in 2 countries.

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 14 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 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 14 Aug 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 ≥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 study lists 4 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 NCT02530281, which also lists 3 linked publications.

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 25 Aug 2021.