Trials Sponsors Conditions Drugs Pricing

Conditions

Palmar Hyperhidrosis

Outcome Measures

Primary Outcomes (1)

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 \[score on a scale from 0 (better) -10 (worse)\].
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
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
Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2
Baseline, Week 2

Study Arms (8)

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)

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)

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)

Interventions

Glycopyrronium cloth, 2.4%Drug

Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium

Group 1 ActiveGroup 2 ActiveGroup 3 ActiveGroup 4 Active

VehicleDrug

Eligibility Criteria

Age9 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Signed informed consent and assent (for subjects under legal adult age).
Age ≥9 years.

Sponsors & Collaborators

Journey Medical Corporation
Industrylead

Study Sites (7)

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Colorado Medical Research Center, Inc.

Denver, Colorado, 80210, United States

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Saint Louis University Dermatology

St Louis, Missouri, 63122, United States

Innovative Dermatology/ ACRC Trials

Plano, Texas, 75024, United States

Virginia Clinical Research, Inc.

Limitations and Caveats

Small sample size

Results Point of Contact

Title: Jordan Adajar
Organization: Dermira, Inc

Study Officials

Kate Doherty
Dermira, Inc.
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

72 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 15, 2019

First Posted

March 19, 2019

Study Start

February 22, 2019

Actual (reported)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (8)

Group 1 Active

Group 1 Vehicle

Group 2 Active

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Group 2 Vehicle

Group 3 Active

Group 3 Vehicle

Group 4 Active

Group 4 Vehicle

You may not qualify if:

Data Sharing

Source record

Documents

Locations