Trials Sponsors Conditions Drugs Pricing

Conditions

Hyperhidrosis Palmar Hyperhidrosis Skin Diseases Sweat Gland Diseases

Keywords

QBREXZAglycopyrronium

Outcome Measures

Primary Outcomes (2)

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.
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.
From Baseline to week 4.

Study Arms (4)

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.

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.

Interventions

Glycopyrronium 2.4 % Medicated ClothDrug

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.

Also known as: Qbrexza

Cohort A glycopyrronium 30 minutes cotton glovesCohort B glycopyrronium 30 minutes under occlusionCohort C glycopyrronium overnight in cotton glovesCohort D glycopyrronium overnight under occlusion

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age9 Years+

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Pariser, Robert J., M.D.
Otherlead
Virginia Clinical Research, Inc.
Othercollaborator

Study Sites (1)

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

MeSH Terms

Conditions

HyperhidrosisSweat Gland DiseasesSkin Diseases

Interventions

Glycopyrrolateglycopyrronium tosylate

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsPyrrolidinesHeterocyclic Compounds, 1-Ring

Study Officials

David M Pariser, MD
Virginia Clinical Research, Inc.
PRINCIPAL INVESTIGATOR

Enrollment

120 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 24, 2021

First Posted

May 28, 2021

You may not qualify if:

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.
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.)
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.

An Open Label Study for Palmar Hyperhydrosis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (4)

Cohort A glycopyrronium 30 minutes cotton gloves

Cohort B glycopyrronium 30 minutes under occlusion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Cohort C glycopyrronium overnight in cotton gloves

Cohort D glycopyrronium overnight under occlusion

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (4)

Cohort A glycopyrronium 30 minutes cotton gloves

Cohort B glycopyrronium 30 minutes under occlusion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Cohort C glycopyrronium overnight in cotton gloves

Cohort D glycopyrronium overnight under occlusion

You may not qualify if:

Data Sharing

Source record

Locations