HyperhidrosisPhase 2NCT02016885
A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
A Phase 2 study testing glycopyrrolate, 1.0%, glycopyrrolate, 2.0% and glycopyrrolate, 3.0% in people with Hyperhidrosis, run by Journey Medical Corporation at 21 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperhidrosis
- What is being tested?
- glycopyrrolate, 1.0%, glycopyrrolate, 2.0% and glycopyrrolate, 3.0%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 21 sitesUnited States
- Study dates
- Nov 2013to Sep 2014
- 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 years and older
- 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.
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Shideler Clinical Research Center
Carmel, Indiana, 46032
J&S Studies, Inc.
College Station, Texas, 77845
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Center For Dermatology Clinical Research
Fremont, California, 94538
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Gary M. Petrus, MD, PA
Little Rock, Arkansas, 72202
Florida Academic Dermatology Center
Miami, Florida, 33136
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
Skin Specialists, PC
Omaha, Nebraska, 68144
Oregon Medical Research Center
Portland, Oregon, 97223
Westend Dermatology Associates
Richmond, Virginia, 23233
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84117
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
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
The Dermatology Group, PC
Verona, New Jersey, 07044
Kenneth R. Beer, MD, PA
West Palm Beach, Florida, 33401
Cypress Medical Research Center, LLC
Wichita, Kansas, 67226
About this study
Official title: A Phase 2, Randomized, Double-Blind, Vehicle Controlled, Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
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.
- Conditions
- Hyperhidrosis
- Being tested
- glycopyrrolate, 1.0%, glycopyrrolate, 2.0%, glycopyrrolate, 3.0%, glycopyrrolate, 4.0%, Vehicle
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glycopyrrolate, 1.0%Drug
Also called DRM04B
glycopyrrolate Topical Wipes, 1.0%
glycopyrrolate, 2.0%Drug
Also called DRM04B
glycopyrrolate Topical Wipes, 2.0%
glycopyrrolate, 3.0%Drug
Also called DRM04B
glycopyrrolate Topical Wipes, 3.0%
glycopyrrolate, 4.0%Drug
Also called DRM04B
glycopyrrolate Topical Wipes, 4.0%
VehicleOther
Also called Placebo
Vehicle Topical Wipes
| Study group | Role | What they receive |
|---|---|---|
| glycopyrrolate, 1.0% | Experimental | glycopyrrolate Topical Wipes, 1.0% Receives: Drug: glycopyrrolate, 1.0% |
| glycopyrrolate, 2.0% | Experimental | glycopyrrolate Topical Wipes, 2.0% Receives: Drug: glycopyrrolate, 2.0% |
| glycopyrrolate, 3.0% | Experimental | glycopyrrolate Topical Wipes, 3.0% Receives: Drug: glycopyrrolate, 3.0% |
| glycopyrrolate, 4.0% | Experimental | glycopyrrolate Topical Wipes, 4.0% Receives: Drug: glycopyrrolate, 4.0% |
| 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
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
Secondary outcomes (4)
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4
Measured: Baseline - Week 4
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6
Measured: Baseline - Week 6
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6
Measured: Baseline - Week 6
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.
Measured: Baseline - Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2014
- Study completionSep 2014
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
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Journey Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lynne M Deans, MT, Study director, Dermira, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016885
- Sponsor's protocol ID
- DRM04-HH01
- Status last verified
- Aug 2021
- First submitted
- 16 Dec 2013
- Last updated
- 25 Aug 2021
- 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
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 2, Randomized, Double-Blind, Vehicle Controlled, Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT02016885
- Acronym / sponsor ID
- DRM04-HH01
- Conditions
- Hyperhidrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Journey Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Posted 13 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 |
|---|---|---|
| glycopyrrolate, 1.0% | Experimental | Drug: glycopyrrolate, 1.0%glycopyrrolate Topical Wipes, 1.0% |
| glycopyrrolate, 2.0% | Experimental | Drug: glycopyrrolate, 2.0%glycopyrrolate Topical Wipes, 2.0% |
| glycopyrrolate, 3.0% | Experimental | Drug: glycopyrrolate, 3.0%glycopyrrolate Topical Wipes, 3.0% |
| glycopyrrolate, 4.0% | Experimental | Drug: glycopyrrolate, 4.0%glycopyrrolate Topical Wipes, 4.0% |
| Vehicle | Placebo comparator | Other: VehicleVehicle Topical Wipes |
Who may qualify
- Ages
- 18 years and older
- 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.
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| glycopyrrolate, 1.0%Also: DRM04Bglycopyrrolate Topical Wipes, 1.0% | Drug | glycopyrrolate, 1.0% |
| glycopyrrolate, 2.0%Also: DRM04Bglycopyrrolate Topical Wipes, 2.0% | Drug | glycopyrrolate, 2.0% |
| glycopyrrolate, 3.0%Also: DRM04Bglycopyrrolate Topical Wipes, 3.0% | Drug | glycopyrrolate, 3.0% |
| glycopyrrolate, 4.0%Also: DRM04Bglycopyrrolate Topical Wipes, 4.0% | Drug | glycopyrrolate, 4.0% |
| VehicleAlso: PlaceboVehicle 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
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.
4 secondary outcomes
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
Results and safety
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 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.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing glycopyrrolate, 1.0%, glycopyrrolate, 2.0% and glycopyrrolate, 3.0% in people with Hyperhidrosis, run by Journey Medical Corporation at 21 sites in United States.
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 9 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 21 sites in United States. 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 13 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). The study lists 2 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 NCT02016885, 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 25 Aug 2021.