Palmar HyperhidrosisPhase 2NCT04906655
An Open Label Study for Palmar Hyperhydrosis
A Phase 2 study testing Glycopyrronium 2.4 % Medicated Cloth in people with Palmar Hyperhidrosis and Hyperhidrosis, run by Pariser, Robert J., M.D. at 1 site in United States.
Trial summary
The purpose of this open-label study is to evaluate the efficacy and safety of different methods of application of glycopyrronium cloth, 2.4% in patients with palmar hyperhidrosis Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palmar Hyperhidrosis, Hyperhidrosis, Sweat Gland Diseases
- What is being tested?
- Glycopyrronium 2.4 % Medicated Cloth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 20 May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be eligible for study participation.
- Subjects must provide fully executed informed e-consent and e-assent (if applicable) prior to any study procedures.
- Age ≥ 9 years.
- Willing to comply with the protocol, including completion of designated virtual study visits and prescribed study treatment regimens.
- Subjects must have access to and the ability and willingness to use their own smart device (e.g., phone, computer, tablet). Subjects must have reliable internet access and video capabilities to conduct virtual visits, e-consent, and ePROs. Subjects must have an active email address that is password protected. Their password must remain confidential throughout the study.
- Subjects must have a street address to which study drug can be delivered and received in a timely manner. (PO Boxes will not be allowed.)
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- Male or non-lactating and non-pregnant females (documentation of a negative urine pregnancy test done by the subject must be done prior to sending study drug.)
- Primary palmar hyperhidrosis for at least 6 months.
- Average sweat severity score of ≥4 at the end of screening. Subjects must complete the diary at least 4 times out of 7 days prior to baseline.
- Females of childbearing potential must be willing to use an acceptable method of birth control during study participation and for 30 days after the last study drug application. Females are considered to be of childbearing potential unless surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation), have been diagnosed as infertile, have same gender sex partner, or are postmenopausal for at least 1 year. Acceptable methods of contraception include: abstinence, oral contraceptives, contraceptive patches/implants, injectable contraceptives, double barrier methods (e.g., condom and spermicide), or an intra-uterine device (IUD). Birth control method must have been stable/unchanged for 12 weeks prior to Baseline and must remain unchanged during study participation and for 30 days after the last study drug application.
- Males must either have been vasectomized or agree to use an acceptable method of birth control with female partners during study participation and for 30 days after the last study drug application.
- Subjects must agree not to donate eggs or sperm (as applicable) during the trial.
- -
Who cannot join
- Subjects meeting any of the following criteria are not eligible for study participation.
- 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. (Note: treatment with botulinum toxin in other areas is not exclusionary.)
- Subjects who are actively participating in an experimental therapy study or who received experimental therapy within 30 days of 5 half-lives (whichever is longer) of the Baseline Visit.
- For subjects that are taking concomitant medications that may have an effect on sweating (i.e., psychotherapeutic medications, centrally acting alpha-2 adrenergic agonists (e.g., clonidine, guanabenz, methyl dopa), or beta blockers, the dose must be stable, in the opinion of the investigator, for two months prior to Baseline. There should be no expected medication changes over the course of the study unless deemed to be medically necessary. (Note: inhaled anticholinergic drugs or beta agonists are allowed.)
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- Intravenous (IV), oral, or topically glycopyrrolate treatment of any systemic treatment with an anticholinergic medication, such as atropine, belladonna, scopolamine, clindinium, or hyoscyamine within 4 weeks prior to Screening.
- Current pregnancy or lactation per patient report.
- 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).
- 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 catherization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.
- History of ventricular arrhythmias, atrial fibrillation, atrial flutter.
- Subjects with known medical procedures or surgeries that are scheduled to occur during the study.
- Subjects who are a poor medical risk because of other systemic diseases or active, uncontrolled infections, or any other condition, which (in the judgement of the investigator) would put the subjects at unacceptable risk for participation in the study.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
About this study
Official title: An Open-label Study to Evaluate the Efficacy and Safety of Different Methods of Application of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
The purpose of this open-label study is to evaluate the efficacy and safety of different methods of application of glycopyrronium cloth, 2.4% in patients with palmar hyperhidrosis
Read the detailed description
This study will assess glycopyrronium cloth, 2.4% in patients with primary palmar hyperhidrosis and compare the efficacy and safety of various application methods in order to determine an optimal method for use in palmar hyperhidrosis. The study will assess four application methods (treatment groups). Data from these cohorts will be reviewed on a continuous basis, and the protocol may be amended to add one or more treatment groups if required to determine the optional conditions of drug application.
This study is open label and unblinded. The treatment groups will be enrolled in cohorts, with each cohort being filled before moving on to the next. Cohort A will be enrolled first, followed by B, C, and D. Each cohort will have 30 subjects. If there are multiple AEs of special interest, the medical monitor may stop enrollment of one or more cohorts or may prematurely terminate a cohort(s).
All visits for this study will be conducted virtually, using HIPAA compliant video conferencing technology. Investigational product (IP) will be shipped overnight to subjects that are deemed eligible for participation.
All subjects will sign an informed e-consent and undergo screening for study eligibility. Key criteria for entry are: primary palmar hyperhidrosis for at least 6 months, an average hand sweat severity score of ≥4 (NRS 0-10 pts) during the screening period. Exclusion criteria includes pregnancy or lactation, secondary hyperhidrosis, prior sympathectomy, open wounds or infection on the hands, and concomitant use of iontophoresis, botulinum toxin, experimental therapy, or unstable doses of anticholinergic medications. Subjects will only be allowed to enroll into one cohort.
Approximately 120 eligible subjects, ≥9 years of age will be enrolled to one of four treatment groups at the Baseline visit.
Cohort Table 1: Treatment Groups A 30 minutes residence time in cotton gloves n=30 B 30 minutes residence time under occlusion n=30 C Overnight in cotton gloves n=30 D Overnight under occlusion n=30
Subjects will be instructed on the application method and will apply study drug at home once each evening before going to bed for 28 days (+/- 2 days). Subjects will complete virtual visits to check for adverse events (AEs) and study drug compliance at Week 1, Week 2, and Week 4. Subjects will exit the study at the Week 4 visit.
- Being tested
- Glycopyrronium 2.4 % Medicated Cloth
- Keywords
- QBREXZA, glycopyrronium
- Medical subject headings
- Hyperhidrosis, Sweat Gland Diseases, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycopyrronium 2.4 % Medicated ClothDrug
Also called Qbrexza
The investigational product (glycopyrronium cloth, 2.4%) is a pre-moistened, medicated cloth towelette that comes in individually wrapped packets. Subjects will receive marketed Qbrexza, one box, containing 30 pouches.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A glycopyrronium 30 minutes cotton gloves | Experimental | Study drug should be applied to clean, dry skin. A single cloth will be used to apply study drug to both hands once daily, at bedtime. The subject will be instructed to apply the study drug as follows:
30 minutes residence time in cotton gloves
1. Complete daily diary.
2. Remove all jewelry.
3. Tear open the top of the pouch at the notch.
4. Wash hands thoroughly with warm water, and dry them.
5. Remove the wipe from the pouch and unfold the wipe.
6. Wipe both hands with the wipe continuously until the wipe is dry (up to 3 minutes).
7. Return the wipe to the pouch and put it back in the box.
8. Carefully put cotton gloves on both hands.
9. Set timer for 30 minutes.
10. After 30 minutes, remove gloves and throw them away. Immediately wash hands thoroughly with warm water and soap, and dry them. Receives: Drug: Glycopyrronium 2.4 % Medicated Cloth |
| Cohort B glycopyrronium 30 minutes under occlusion | Experimental | Study drug should be applied to clean, dry skin. A single cloth will be used to apply study drug to both hands once daily, at bedtime. The subject will be instructed to apply the study drug as follows:
30 minutes residence time under occlusion
1. Complete daily diary.
2. Remove all jewelry.
3. Tear open the top of the pouch at the notch.
4. Wash hands thoroughly with warm water, and dry them.
5. Remove the wipe from the pouch and unfold the wipe.
6. Wipe both hands with the wipe continuously until the wipe is dry (up to 3 minutes).
7. Return the wipe to the pouch and put it back in the box.
8. Carefully put gloves on both hands.
9. Set timer for 30 minutes.
10. After 30 minutes, remove gloves and throw them away. Immediately wash hands thoroughly with warm water and soap, and dry them. Receives: Drug: Glycopyrronium 2.4 % Medicated Cloth |
| Cohort C glycopyrronium overnight in cotton gloves | Experimental | Study drug should be applied to clean, dry skin. A single cloth will be used to apply study drug to both hands once daily, at bedtime. The subject will be instructed to apply the study drug as follows:
Overnight in cotton gloves
1. Complete daily diary
2. Remove all jewelry.
3. Tear open the top of the pouch at the notch.
4. Wash hands thoroughly with warm water, and dry them.
5. Remove the wipe from the pouch and unfold the wipe.
6. Wipe both hands with the wipe continuously until the wipe is dry (up to 3 minutes).
7. Return the wipe to the pouch and put it back in the box.
8. Carefully put on the cotton gloves on both hands and go to bed.
9. In the morning, after at least 4 hours of wearing the gloves , remove the cotton gloves and throw them away.
10. Immediately wash hands thoroughly with warm water and soap, and dry them. Receives: Drug: Glycopyrronium 2.4 % Medicated Cloth |
| Cohort D glycopyrronium overnight under occlusion | Experimental | Study drug should be applied to clean, dry skin. A single cloth will be used to apply study drug to both hands once daily, at bedtime. The subject will be instructed to apply the study drug as follows:
Overnight under occlusion
1. Complete daily diary
2. Remove all jewelry.
3. Tear open the top of the pouch at the notch.
4. Wash hands thoroughly with warm water, and dry them.
5. Remove the wipe from the pouch and unfold the wipe.
6. Wipe both hands with the wipe continuously until the wipe is dry (up to 3 minutes).
7. Return the wipe to the pouch and put it back in the box.
8. Carefully put on the occlusive gloves and go to bed.
9. In the morning, after at least 4 hours of wearing the gloves, remove the occlusive gloves and throw them away.
10. Immediately wash hands thoroughly with warm water and soap, and dry them. Receives: Drug: Glycopyrronium 2.4 % Medicated Cloth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of the average hand sweating score (Daily Diary Question 1) from the week of Screen-Baseline to the final week of study treatment.
The hand sweat severity (HSS) item is a patient reported outcome, collected nightly, and is designed to measure the severity of palmar hyperhidrosis.
Measured: From the week of Screen-Baseline (7 days prior to the end of the screening visit) to the final week of study treatment (week 4).
Proportion of subjects who have a >2 grade improvement in HDSS from baseline to 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.
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.
- First posted28 May 2021
- Study start1 Oct 2020
- Primary completion20 May 2021
- Study completion20 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Model description
- The study is open label, and treatment groups are assigned by Cohorts starting with A, then B, then C, then D. The method of treatment will be filled on a first come, first served basis. Movement from one cohort to the next will be determined by the medical monitor after evaluation of the safety and efficacy data that is available after each cohort is filled. There may be a very brief enrollment (baseline) pause for this to occur.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pariser, Robert J., M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Clinical Research, Inc.
- Responsible party
- Sponsor
- Investigators
- David M Pariser, MD, Principal investigator, Virginia Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906655
- Sponsor's protocol ID
- PQB-001
- Status last verified
- May 2021
- First submitted
- 24 May 2021
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Efficacy and Safety of Different Methods of Application of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
- ClinicalTrials.gov ID
- NCT04906655
- Acronym / sponsor ID
- PQB-001
- Keywords
- QBREXZA, glycopyrronium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Pariser, Robert J., M.D.University, hospital or other
- Collaborators
- Virginia Clinical Research, Inc.
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
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 open-label study is to evaluate the efficacy and safety of different methods of application of glycopyrronium cloth, 2.4% in patients with palmar hyperhidrosis
Detailed description
This study will assess glycopyrronium cloth, 2.4% in patients with primary palmar hyperhidrosis and compare the efficacy and safety of various application methods in order to determine an optimal method for use in palmar hyperhidrosis. The study will assess four application methods (treatment groups). Data from these cohorts will be reviewed on a continuous basis, and the protocol may be amended to add one or more treatment groups if required to determine the optional conditions of drug application.
This study is open label and unblinded. The treatment groups will be enrolled in cohorts, with each cohort being filled before moving on to the next. Cohort A will be enrolled first, followed by B, C, and D. Each cohort will have 30 subjects. If there are multiple AEs of special interest, the medical monitor may stop enrollment of one or more cohorts or may prematurely terminate a cohort(s).
All visits for this study will be conducted virtually, using HIPAA compliant video conferencing technology. Investigational product (IP) will be shipped overnight to subjects that are deemed eligible for participation.
All subjects will sign an informed e-consent and undergo screening for study eligibility. Key criteria for entry are: primary palmar hyperhidrosis for at least 6 months, an average hand sweat severity score of ≥4 (NRS 0-10 pts) during the screening period. Exclusion criteria includes pregnancy or lactation, secondary hyperhidrosis, prior sympathectomy, open wounds or infection on the hands, and concomitant use of iontophoresis, botulinum toxin, experimental therapy, or unstable doses of anticholinergic medications. Subjects will only be allowed to enroll into one cohort.
Approximately 120 eligible subjects, ≥9 years of age will be enrolled to one of four treatment groups at the Baseline visit.
Cohort Table 1: Treatment Groups A 30 minutes residence time in cotton gloves n=30 B 30 minutes residence time under occlusion n=30 C Overnight in cotton gloves n=30 D Overnight under occlusion n=30
Subjects will be instructed on the application method and will apply study drug at home once each evening before going to bed for 28 days (+/- 2 days). Subjects will complete virtual visits to check for adverse events (AEs) and study drug compliance at Week 1, Week 2, and Week 4. Subjects will exit the study at the Week 4 visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study is open label, and treatment groups are assigned by Cohorts starting with A, then B, then C, then D. The method of treatment will be filled on a first come, first served basis. Movement from one cohort to the next will be determined by the medical monitor after evaluation of the safety and efficacy data that is available after each cohort is filled. There may be a very brief enrollment (baseline) pause for this to occur.
| Arm | Type | Receives |
|---|---|---|
| Cohort A glycopyrronium 30 minutes cotton gloves | Experimental | Drug: Glycopyrronium 2.4 % Medicated ClothStudy drug should be applied to clean, dry skin. A single cloth will be used to apply study drug to both hands once daily, at bedtime. The subject will be instructed to apply the study drug as follows: 30 minutes residence time in cotton gloves 1. Complete daily diary. 2. Remove all jewelry. 3. Tear open the top of the pouch at the notch. 4. Wash hands thoroughly with warm water, and dry them. 5. Remove the wipe from the pouch and unfold the wipe. 6. Wipe both hands with the wipe continuously until the wipe is dry (up to 3 minutes). 7. Return the wipe to the pouch and put it back in the box. 8. Carefully put cotton gloves on both hands. 9. Set timer for 30 minutes. 10. After 30 minutes, remove gloves and throw them away. Immediately wash hands thoroughly with warm water and soap, and dry them. |
| Cohort B glycopyrronium 30 minutes under occlusion | Experimental | Drug: Glycopyrronium 2.4 % Medicated ClothStudy drug should be applied to clean, dry skin. A single cloth will be used to apply study drug to both hands once daily, at bedtime. The subject will be instructed to apply the study drug as follows: 30 minutes residence time under occlusion 1. Complete daily diary. 2. Remove all jewelry. 3. Tear open the top of the pouch at the notch. 4. Wash hands thoroughly with warm water, and dry them. 5. Remove the wipe from the pouch and unfold the wipe. 6. Wipe both hands with the wipe continuously until the wipe is dry (up to 3 minutes). 7. Return the wipe to the pouch and put it back in the box. 8. Carefully put gloves on both hands. 9. Set timer for 30 minutes. 10. After 30 minutes, remove gloves and throw them away. Immediately wash hands thoroughly with warm water and soap, and dry them. |
| Cohort C glycopyrronium overnight in cotton gloves | Experimental | Drug: Glycopyrronium 2.4 % Medicated ClothStudy drug should be applied to clean, dry skin. A single cloth will be used to apply study drug to both hands once daily, at bedtime. The subject will be instructed to apply the study drug as follows: Overnight in cotton gloves 1. Complete daily diary 2. Remove all jewelry. 3. Tear open the top of the pouch at the notch. 4. Wash hands thoroughly with warm water, and dry them. 5. Remove the wipe from the pouch and unfold the wipe. 6. Wipe both hands with the wipe continuously until the wipe is dry (up to 3 minutes). 7. Return the wipe to the pouch and put it back in the box. 8. Carefully put on the cotton gloves on both hands and go to bed. 9. In the morning, after at least 4 hours of wearing the gloves , remove the cotton gloves and throw them away. 10. Immediately wash hands thoroughly with warm water and soap, and dry them. |
| Cohort D glycopyrronium overnight under occlusion | Experimental | Drug: Glycopyrronium 2.4 % Medicated ClothStudy drug should be applied to clean, dry skin. A single cloth will be used to apply study drug to both hands once daily, at bedtime. The subject will be instructed to apply the study drug as follows: Overnight under occlusion 1. Complete daily diary 2. Remove all jewelry. 3. Tear open the top of the pouch at the notch. 4. Wash hands thoroughly with warm water, and dry them. 5. Remove the wipe from the pouch and unfold the wipe. 6. Wipe both hands with the wipe continuously until the wipe is dry (up to 3 minutes). 7. Return the wipe to the pouch and put it back in the box. 8. Carefully put on the occlusive gloves and go to bed. 9. In the morning, after at least 4 hours of wearing the gloves, remove the occlusive gloves and throw them away. 10. Immediately wash hands thoroughly with warm water and soap, and dry them. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects must meet all of the following criteria to be eligible for study participation.
- Subjects must provide fully executed informed e-consent and e-assent (if applicable) prior to any study procedures.
- Age ≥ 9 years.
- Willing to comply with the protocol, including completion of designated virtual study visits and prescribed study treatment regimens.
- Subjects must have access to and the ability and willingness to use their own smart device (e.g., phone, computer, tablet). Subjects must have reliable internet access and video capabilities to conduct virtual visits, e-consent, and ePROs. Subjects must have an active email address that is password protected. Their password must remain confidential throughout the study.
Key exclusion criteria (17 listed)
- Subjects meeting any of the following criteria are not eligible for study participation.
- 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. (Note: treatment with botulinum toxin in other areas is not exclusionary.)
- Subjects who are actively participating in an experimental therapy study or who received experimental therapy within 30 days of 5 half-lives (whichever is longer) of the Baseline Visit.
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 2.4 % Medicated ClothAlso: QbrexzaThe investigational product (glycopyrronium cloth, 2.4%) is a pre-moistened, medicated cloth towelette that comes in individually wrapped packets. Subjects will receive marketed Qbrexza, one box, containing 30 pouches. | Drug | Cohort A glycopyrronium 30 minutes cotton gloves, Cohort B glycopyrronium 30 minutes under occlusion, Cohort C glycopyrronium overnight in cotton gloves, Cohort D glycopyrronium overnight under occlusion |
Primary outcome
Mean change of the average hand sweating score (Daily Diary Question 1) from the week of Screen-Baseline to the final week of study treatment.
Time frame: From the week of Screen-Baseline (7 days prior to the end of the screening visit) to the final week of study treatment (week 4).
The hand sweat severity (HSS) item is a patient reported outcome, collected nightly, and is designed to measure the severity of palmar hyperhidrosis.
Proportion of subjects who have a >2 grade improvement in HDSS from baseline to week 4.
Time frame: From Baseline to 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- 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.
David M Pariser, MD principal investigator
Virginia Clinical Research, Inc.
1 site 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 2.4 % Medicated Cloth in people with Palmar Hyperhidrosis and Hyperhidrosis, run by Pariser, Robert J., M.D. at 1 site 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 13 inclusion and 17 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 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of the average hand sweating score (Daily Diary Question 1) from the week of Screen-Baseline to the final week of study treatment. (time frame: From the week of Screen-Baseline (7 days prior to the end of the screening visit) to the final week of study treatment (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?
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 28 May 2021.