HyperhidrosisPhase 3NCT02553798
Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
A Phase 3 study testing Glycopyrronium Topical Wipes in people with Hyperhidrosis, run by Journey Medical Corporation at 48 sites in 2 countries.
Trial summary
This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or DRM04-HH05 studies. 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?
- No, everyone receives an active treatment
- How many people
- 564 participants
- Where
- 48 sitesin 2 countries
- Study dates
- Aug 2015to Dec 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
- Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80% treatment compliance
- Male or females
Who cannot join
- Subject has a clinically significant abnormality on physical exam, vital signs or ECG at the Week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further treatment with glycopyrronium contraindicated
- Male with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy
- Any other condition which, in the judgement of the Investigator, would put the subject at unacceptable risk for participation in the study
Trial locations and contacts
48 sites in 2 countries.
48 sites in 2 countries
United States40 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106-5239
DermResearch
Austin, Texas, 78759
Skin Care Research, Inc.
Boca Raton, Florida, 33486
Study Protocol, Inc
Boynton Beach, Florida, 33437
Shideler Clinical Research Center
Carmel, Indiana, 46032
Dermatology and Laser Center of Charleston, PA
Charleston, Pennsylvania, 29414
Charlottesville Medical Research
Charlottesville, Virginia, 22911
J & S Studies, Inc.
College Station, Texas, 77845
Modern Research Associates, PLLC
Dallas, Texas, 75231
Colorado Medical Research Center, Inc
Denver, Colorado, 80210
Zel Skin & Laser Specialist
Edina, Minnesota, 55424
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Rivergate Dermatology Research Center, PLLC
Goodlettsville, Tennessee, 37072
The University of Texas Dermatology Clinical Research Center
Houston, Texas, 77030
Dermatology Research Associates
Los Angeles, California, 90045
International Dermatology Research, Inc.
Miami, Florida, 33144
Coastal Medical Research Group LLC
Mobile, Alabama, 36608
Clinical Research Associates, Inc
Nashville, Tennessee, 37203
Schweiger Dermatology Group
New York, New York, 10022
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
Tory Sullivan, MD
North Miami Beach, Florida, 33162
Meridian Clinical Research
Omaha, Nebraska, 68134
Austin Institute for Clinical Research
Pflugerville, Texas, 78860
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
ACRC Trials
Plano, Texas, 75024
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Skin Search of Rochester, Inc
Rochester, New York, 14623
Lawrence J. Green M.D., LLC
Rockville, Maryland, 20850
Northwest Arkansas Clinical Trials Center, PLLC
Rogers, Arkansas, 72758
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84117
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Therapeutics Clinical Research
San Diego, California, 92123
Clinical Science Institute
Santa Monica, California, 90404
Dermatology Associates
Seattle, Washington, 98101
Premier Clinical Research
Spokane, Washington, 99202
St. Louis University Dermatology
St Louis, Missouri, 63122
Jordan Valley Dermatology Center, LLC
West Jordan, Utah, 84088
Research Institute of the Southeast
West Palm Beach, Florida, 33401
Prairie Health and Wellness
Wichita, Kansas, 67206
Germany8 sites
Klinik für Dermatologie, Venerologie und Allergologie Allergie-Centrum-Charité
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
Gemeinschaftspraxis Weber & Cranic
Schweinfurt, 97421
About this study
Official title: An Open-label Study Assessing Long-term Safety of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or DRM04-HH05 studies.
Read the detailed description
Safety will be assessed through adverse events, blood and urine laboratory tests, physical examination, pulse and blood pressure. Local skin reactions will be assessed including burning/stinging, pruritus, edema, erythema, dryness and scaling.
- Conditions
- Hyperhidrosis
- Being tested
- Glycopyrronium Topical Wipes
- 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
Glycopyrronium Topical Wipes
| Study group | Role | What they receive |
|---|---|---|
| Glycopyrronium | Experimental | Glycopyrronium Topical Wipes Receives: Drug: Glycopyrronium Topical Wipes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term Safety Assessed Through Adverse Events and Local Skin Reactions
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
Measured: Day 1 - Week 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2016
- Study completionDec 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 (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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 564 participants (actual)
Sponsor and investigators
- Lead sponsor
- Journey Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lynne Deans, MT, Study director, Dermira, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553798
- Sponsor's protocol ID
- DRM04-HH06
- Status last verified
- Aug 2021
- First submitted
- 15 Sep 2015
- Last updated
- 25 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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
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
- An Open-label Study Assessing Long-term Safety of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT02553798
- Acronym / sponsor ID
- DRM04-HH06
- Conditions
- Hyperhidrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- Journey Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Posted 25 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or DRM04-HH05 studies.
Detailed description
Safety will be assessed through adverse events, blood and urine laboratory tests, physical examination, pulse and blood pressure. Local skin reactions will be assessed including burning/stinging, pruritus, edema, erythema, dryness and scaling.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glycopyrronium | Experimental | Drug: Glycopyrronium Topical WipesGlycopyrronium Topical Wipes |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80% treatment compliance
- Male or females
Key exclusion criteria (3 listed)
- Subject has a clinically significant abnormality on physical exam, vital signs or ECG at the Week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further treatment with glycopyrronium contraindicated
- Male with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy
- Any other condition which, in the judgement of the Investigator, would put the subject at unacceptable risk for participation in the study
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: DRM04Glycopyrronium Topical Wipes | Drug | Glycopyrronium |
Primary outcome
Long-term Safety Assessed Through Adverse Events and Local Skin Reactions
Time frame: Day 1 - Week 44
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
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 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.
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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 Deans, MT study director
Dermira, Inc.
48 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 48 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 2 inclusion and 3 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 48 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. 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 25 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?
Long-term Safety Assessed Through Adverse Events and Local Skin Reactions (time frame: Day 1 - Week 44). 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 NCT02553798, 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.