Skip to main content
OpenTrials
Completed

NCT Number: NCT02553798

Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis

This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or DRM04-HH05 studies.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hyperhidrosis Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Klinik für Dermatologie, Venerologie und Allergologie Allergie-Centrum-Charité, Berlin, Germany

Loading trial locations.

About this study

Safety will be assessed through adverse events, blood and urine laboratory tests, physical examination, pulse and blood pressure. Local skin reactions will be assessed including burning/stinging, pruritus, edema, erythema, dryness and scaling.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80% treatment compliance
  • Male or females

Exclusion criteria

  • Subject has a clinically significant abnormality on physical exam, vital signs or ECG at the Week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further treatment with glycopyrronium contraindicated
  • Male with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy
  • Any other condition which, in the judgement of the Investigator, would put the subject at unacceptable risk for participation in the study

Treatment and study plan

glycopyrronium Topical Wipes

Drug

Glycopyrronium Topical Wipes

Other names: DRM04

Primary outcomes

  1. Long-term Safety Assessed Through Adverse Events and Local Skin Reactions

    Time frame: Day 1 - Week 44

    The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.

Other outcomes

  1. Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4

    Time frame: Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET

    Subjects are acclimated to the environment for 30 minutes. Dry gauze is weighed. The dry gauze is then applied to the subject's axilla with the arm down by the subject's side or on their lap during the 5-minute period of sweat production. The gauze with the sweat is then weighed. The difference between the Weight of the gauze with sweat and the dry gauze is the gravimetric sweat measurement in mg/5min.

  2. Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS)

    Time frame: Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET

    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.

  3. Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 44/ET

    Time frame: Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET

    The Dermatology Life Quality Index DLQI is a ten question questionnaire, used to measure the impact of skin disease on the quality of life of an affected person. The scoring of each question is as follows: Very much (3), A lot (2), A little (1), Not at all (0), Not relevant (0). Is calculated by summing the score of each question resulting in a max of 30 and a min of 0. Higher the score the more Quality of life is impaired.

Sponsors and collaborators

Lead sponsor

Journey Medical Corporation

Industry

Registry information

Official study title

An Open-label Study Assessing Long-term Safety of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 18, 2015
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.