Clinical trial NCT03880266: A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
Official title: A Phase 2, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Palmar Hyperhidrosis
Lead sponsor: Journey Medical Corporation
Sponsor class: INDUSTRY
First posted: 2019-03-19
Enrollment: 72
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a pilot study assessing the safety and efficacy of glycopyrronium cloth in patients with palmar hyperhidrosis

Eligibility criteria: 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. 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.
7. Male or non-pregnant (negative urine pregnancy test in female subjects of child-bearing potential), non-lactating females.

Exclusion Criteria:

1. Subjects who have taken or are currently taking glycopyrronium cloth, 2.4%.
2. Prior surgical procedure for hyperhidrosis.
3. Iontophoresis for the palms within 4 weeks of Baseline.
4. Treatment with botulinum toxin (e.g., Botox®) for palmar hyperhidrosis within 1 year of Baseline.
5. Open wounds or inflammatory lesions on the hands or, any condition that may alter the barrier function of the skin on the hands.
6. 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).
7. Known history of Sjögren's syndrome or Sicca syndrome.
8. 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.
9. Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.

Primary outcomes:
measure: Mean Change From Baseline to Week 2 in Hand Sweating Severity Score
timeFrame: Baseline, Week 2
Secondary outcomes:
measure: Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2
timeFrame: Baseline, Week 2
measure: Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
timeFrame: Baseline, Week 2
measure: Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
timeFrame: Baseline, Week 2
measure: Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2
timeFrame: Baseline, Week 2
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Denver
country: United States
facility: Colorado Medical Research Center, Inc.
state: Colorado
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Saint Louis
country: United States
facility: Saint Louis University Dermatology
state: Missouri
city: Plano
country: United States
facility: Innovative Dermatology/ ACRC Trials
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: Dermira, Inc.
name: Kate Doherty
role: STUDY_DIRECTOR
References: