A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis

NCT03880266 | Completed Phase 2 Results FDA Drug

• 1 other identifier: DRM04-HH10
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 7

Brief Summary

The objective of this study is to assess the efficacy and safety of glycopyrronium cloth, 2.4% when used to treat palmar hyperhidrosis.

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)

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)

Drug: Vehicle

Group 3 Active

ACTIVE COMPARATOR

Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes

Drug: Glycopyrronium cloth, 2.4%

Group 3 Vehicle

PLACEBO COMPARATOR

Vehicle cloth applied to the hands once daily for 14 days: 15 minutes

Drug: Vehicle

Group 4 Active

ACTIVE COMPARATOR

Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes

Drug: Glycopyrronium cloth, 2.4%

Group 4 Vehicle

PLACEBO COMPARATOR

Vehicle cloth applied to the hands once daily for 14 days: 30 minutes

Drug: Vehicle

Interventions

Glycopyrronium cloth, 2.4% DRUG

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

Group 1 Active; Group 2 Active; Group 3 Active; Group 4 Active

Vehicle DRUG

Pre-saturated 100% polypropylene, nonwoven, fabric cloth

Group 1 Vehicle; Group 2 Vehicle; Group 3 Vehicle; Group 4 Vehicle

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Journey Medical Corporation: lead

Study Sites (7)

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Colorado Medical Research Center, Inc.

Denver, Colorado, 80210, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Saint Louis University Dermatology

St Louis, Missouri, 63122, United States

Location

Innovative Dermatology/ ACRC Trials

Plano, Texas, 75024, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

Limitations and Caveats

Small sample size

Results Point of Contact

• Title: Jordan Adajar
• Organization: Dermira, Inc

jordan.adajar@dermira.com

650-421-2919

Study Officials

• Kate Doherty

  Dermira, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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
• Primary Completion: May 24, 2019
• Study Completion: May 24, 2019
• Last Updated: August 25, 2021
• Results First Posted: March 15, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)