Phase 2 N=72 Randomized Triple-blind Treatment

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

Palmar Hyperhidrosis

Bottom Line

View on ClinicalTrials.gov: NCT03880266 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: Mean Change From Baseline to Week 2 in Hand Sweating Severity Score — -2.14; -0.56; -1.64; -3.03 score on a scale — p=0.244

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Glycopyrronium cloth, 2.4% (Drug); Vehicle (Drug)
Age: Pediatric, Adult, Older Adult · 9+ yrs
Sex: All
Sponsor: Journey Medical Corporation
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline to Week 2 in Hand Sweating Severity Score	-2.14; -0.56; -1.64; -3.03; -2.53; -2.20	0.244
SECONDARY Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2	3; 0; 1; 2; 1; 2	1.000
SECONDARY Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2	-69.8; 136.7; -15.3; -159.4; -113.5; 38.1	0.093
SECONDARY Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2	-17.1; 16.5; -7.5; -31.8; -26.8; 11.4	0.130
SECONDARY Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2	1; 1; 3; 2; 4; 0	0.515

Summary

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

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03880266). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.