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Glycopyrronium cloth, 2.4%

Phase 2

Palmar Hyperhidrosis | Small molecule | Dermatology |Journey Medical Corporation|Last Updated: Aug 25, 2021

Target and mechanism

Molecular targetCHRM1, CHRM3, CHRM4, CHRM2, CHRM5
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

Glycopyrronium cloth, 2.4% · 1 trial · 1 indication

Phase 2 1
NCT03880266A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar HyperhidrosisPalmar Hyperhidrosis
COMPLETED72 Analytics
PHASE2COMPLETED
A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
Palmar HyperhidrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Change From Baseline to Week 2 in Hand Sweating Severity Score
Baseline, Week 2

The Hand Sweat Severity Score is a patient reported outcome, designed to measure the severity of palmar hyperhidrosis \[score on a scale from 0 (better) -10 (worse)\].

Secondary Endpoints

Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2
Baseline, Week 2
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
Baseline, Week 2
Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
Baseline, Week 2
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1 ActiveACTIVE_COMPARATORGlycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
Group 1 VehiclePLACEBO_COMPARATORVehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
Group 2 ActiveACTIVE_COMPARATORGlycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
Group 2 VehiclePLACEBO_COMPARATORVehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
Group 3 ActiveACTIVE_COMPARATORGlycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
Group 3 VehiclePLACEBO_COMPARATORVehicle cloth applied to the hands once daily for 14 days: 15 minutes
Group 4 ActiveACTIVE_COMPARATORGlycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
Group 4 VehiclePLACEBO_COMPARATORVehicle cloth applied to the hands once daily for 14 days: 30 minutes

Interventions

NameTypeDescription
Glycopyrronium cloth, 2.4%DRUGPre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium
VehicleDRUGPre-saturated 100% polypropylene, nonwoven, fabric cloth
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Eligibility Criteria

Age Range9 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Signed informed consent and assent (for subjects under legal adult age). 2. Age ≥9 years. 3. Primary palmar hyperhidrosis for at least 6 months duration. 4. Average sweat severity score of ≥4 at Baseline. 5. Hyperhidrosis Disease Severity Scale of 3 or 4 at Baseline. 6. Willi...

Countries:United States
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Frequently asked questions about Glycopyrronium cloth, 2.4%

What is glycopyrronium cloth, 2.4%?

Glycopyrronium cloth, 2.4% is an investigational topical small molecule being developed by Journey Medical Corporation for palmar hyperhidrosis, a condition of excessive sweating on the palms. It is applied as a cloth formulation and is in Phase 2 clinical development. It is not approved by the FDA.

What is glycopyrronium cloth, 2.4% used for?

Glycopyrronium cloth, 2.4% is being studied for the treatment of palmar hyperhidrosis, a dermatologic condition involving excessive sweating of the hands. The clinical program has focused on this indication, and the drug remains investigational rather than approved for any use.

What does glycopyrronium cloth, 2.4% target?

Glycopyrronium cloth, 2.4% targets the muscarinic acetylcholine receptors CHRM1, CHRM2, CHRM3, CHRM4, and CHRM5. It acts as an antagonist at these receptors, blocking muscarinic signaling. This mechanism underlies its development as a topical treatment for excessive sweating in palmar hyperhidrosis.

Who is developing glycopyrronium cloth, 2.4%?

Journey Medical Corporation, which trades under the ticker DERM, is developing glycopyrronium cloth, 2.4% for palmar hyperhidrosis. The company is the sponsor of the clinical program for this topical small molecule formulation.

What phase is glycopyrronium cloth, 2.4% in?

Glycopyrronium cloth, 2.4% is in Phase 2 development. It is investigational and has not been approved by the FDA. The Phase 2 trial for palmar hyperhidrosis has been completed, and no trials are currently listed as active.

What clinical trials is glycopyrronium cloth, 2.4% in?

Glycopyrronium cloth, 2.4% has been evaluated in one completed Phase 2 trial, NCT03880266, titled A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis. The trial enrolled 72 participants in the United States, was randomized, double-blind, and placebo-controlled, and included patients aged 9 years and older.