Palmar HyperhidrosisPhase 2NCT03880266
A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
A Phase 2 study testing Glycopyrronium cloth, 2.4% in people with Palmar Hyperhidrosis, run by Journey Medical Corporation at 7 sites in United States.
Trial summary
The objective of this study is to assess the efficacy and safety of glycopyrronium cloth, 2.4% when used to treat palmar hyperhidrosis. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Palmar Hyperhidrosis
- What is being tested?
- Glycopyrronium cloth, 2.4%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 7 sitesUnited States
- Study dates
- 22 Feb 2019to 24 May 2019
- 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 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent and assent (for subjects under legal adult age).
- Age ≥9 years.
- Primary palmar hyperhidrosis for at least 6 months duration.
- Average sweat severity score of ≥4 at Baseline.
- Hyperhidrosis Disease Severity Scale of 3 or 4 at Baseline.
- Willing to comply with the protocol. Subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol.
- Male or non-pregnant (negative urine pregnancy test in female subjects of child-bearing potential), non-lactating females.
Who cannot join
- Subjects who have taken or are currently taking glycopyrronium cloth, 2.4%.
- Prior surgical procedure for hyperhidrosis.
- Iontophoresis for the palms within 4 weeks of Baseline.
- Treatment with botulinum toxin (e.g., Botox®) for palmar hyperhidrosis within 1 year of Baseline.
- Open wounds or inflammatory lesions on the hands or, any condition that may alter the barrier function of the skin on the hands.
- Secondary palmar hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis (e.g., lymphoma, malaria, severe anxiety not controlled by medication, carcinoid syndrome, substance abuse, hyperthyroidism).
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- Known history of Sjögren's syndrome or Sicca syndrome.
- History of glaucoma, inflammatory bowel disease, toxic megacolon, active febrile illness, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis or myasthenia gravis.
- Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Colorado Medical Research Center, Inc.
Denver, Colorado, 80210
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
International Dermatology Research, Inc.
Miami, Florida, 33144
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
Innovative Dermatology/ ACRC Trials
Plano, Texas, 75024
Saint Louis University Dermatology
St Louis, Missouri, 63122
About this study
Official title: A Phase 2, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
The objective of this study is to assess the efficacy and safety of glycopyrronium cloth, 2.4% when used to treat palmar hyperhidrosis.
Read the detailed description
This is a pilot study assessing the safety and efficacy of glycopyrronium cloth in patients with palmar hyperhidrosis
- Conditions
- Palmar Hyperhidrosis
- Being tested
- Glycopyrronium cloth, 2.4%, Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycopyrronium cloth, 2.4%Drug
Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium
VehicleDrug
Pre-saturated 100% polypropylene, nonwoven, fabric cloth
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Active | Active comparator | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove) Receives: Drug: Glycopyrronium cloth, 2.4% |
| Group 1 Vehicle | Placebo comparator | Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove) Receives: Drug: Vehicle |
| Group 2 Active | Active comparator | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove) Receives: Drug: Glycopyrronium cloth, 2.4% |
| Group 2 Vehicle | Placebo comparator | Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove) Receives: Drug: Vehicle |
| Group 3 Active | Active comparator | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes Receives: Drug: Glycopyrronium cloth, 2.4% |
| Group 3 Vehicle | Placebo comparator | Vehicle cloth applied to the hands once daily for 14 days: 15 minutes Receives: Drug: Vehicle |
| Group 4 Active | Active comparator | Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes Receives: Drug: Glycopyrronium cloth, 2.4% |
| Group 4 Vehicle | Placebo comparator | Vehicle cloth applied to the hands once daily for 14 days: 30 minutes Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline to Week 2 in Hand Sweating Severity Score
The Hand Sweat Severity Score is a patient reported outcome, designed to measure the severity of palmar hyperhidrosis [score on a scale from 0 (better) -10 (worse)].
Measured: Baseline, Week 2
Secondary outcomes (4)
Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2
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 (better), 2, 3, 4 (worse)
Measured: Baseline, Week 2
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; average of the change in the gravimetric measurement of sweat produced at baseline compared with Week 2
Measured: Baseline, Week 2
Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; calculation of percentage difference in sweat production at week 2 compared to baseline sweat production
Measured: Baseline, Week 2
Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2
Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; confidence interval represents difference between vehicle and active group
Measured: Baseline, Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start22 Feb 2019
- Primary completion24 May 2019
- Study completion24 May 2019
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.
- Other trials for Palmar 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Journey Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kate Doherty, Study director, Dermira, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880266
- Sponsor's protocol ID
- DRM04-HH10
- Status last verified
- Aug 2021
- First submitted
- 15 Mar 2019
- Last updated
- 25 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 Efficacy and Safety Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
- ClinicalTrials.gov ID
- NCT03880266
- Acronym / sponsor ID
- DRM04-HH10
- Conditions
- Palmar Hyperhidrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Journey Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 24 May 2019 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Posted 15 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the efficacy and safety of glycopyrronium cloth, 2.4% when used to treat palmar hyperhidrosis.
Detailed description
This is a pilot study assessing the safety and efficacy of glycopyrronium cloth in patients with palmar hyperhidrosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group 1 Active | Active comparator | Drug: Glycopyrronium cloth, 2.4%Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove) |
| Group 1 Vehicle | Placebo comparator | Drug: VehicleVehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove) |
| Group 2 Active | Active comparator | Drug: Glycopyrronium cloth, 2.4%Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove) |
| Group 2 Vehicle | Placebo comparator | Drug: VehicleVehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove) |
| Group 3 Active | Active comparator | Drug: Glycopyrronium cloth, 2.4%Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes |
| Group 3 Vehicle | Placebo comparator | Drug: VehicleVehicle cloth applied to the hands once daily for 14 days: 15 minutes |
| Group 4 Active | Active comparator | Drug: Glycopyrronium cloth, 2.4%Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes |
| Group 4 Vehicle | Placebo comparator | Drug: VehicleVehicle cloth applied to the hands once daily for 14 days: 30 minutes |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent and assent (for subjects under legal adult age).
- Age ≥9 years.
- Primary palmar hyperhidrosis for at least 6 months duration.
- Average sweat severity score of ≥4 at Baseline.
- Hyperhidrosis Disease Severity Scale of 3 or 4 at Baseline.
Key exclusion criteria (9 listed)
- Subjects who have taken or are currently taking glycopyrronium cloth, 2.4%.
- Prior surgical procedure for hyperhidrosis.
- Iontophoresis for the palms within 4 weeks of Baseline.
- Treatment with botulinum toxin (e.g., Botox®) for palmar hyperhidrosis within 1 year of Baseline.
- Open wounds or inflammatory lesions on the hands or, any condition that may alter the barrier function of the skin on the hands.
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 cloth, 2.4%Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium | Drug | Group 1 Active, Group 2 Active, Group 3 Active, Group 4 Active |
| VehiclePre-saturated 100% polypropylene, nonwoven, fabric cloth | Drug | Group 1 Vehicle, Group 2 Vehicle, Group 3 Vehicle, Group 4 Vehicle |
Primary outcome
Mean Change From Baseline to Week 2 in Hand Sweating Severity Score
Time frame: Baseline, Week 2
The Hand Sweat Severity Score is a patient reported outcome, designed to measure the severity of palmar hyperhidrosis [score on a scale from 0 (better) -10 (worse)].
4 secondary outcomes
Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2
Time frame: Baseline, Week 2
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
Time frame: Baseline, Week 2
Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
Time frame: Baseline, Week 2
Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2
Time frame: Baseline, Week 2
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.
- Individual participant dataSharing planned: No
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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.
Kate Doherty study director
Dermira, Inc.
7 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 Glycopyrronium cloth, 2.4% in people with Palmar Hyperhidrosis, run by Journey Medical Corporation at 7 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 7 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 7 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 15 Mar 2021). 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?
Mean Change From Baseline to Week 2 in Hand Sweating Severity Score (time frame: Baseline, Week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.