Clinical trial NCT02682238: A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 Gel in Subjects With Palmar Hyperhidrosis
Official title: A Multicenter, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Local Tolerability of Topically Applied BBI-4000 (Sofpironium Bromide) 15% Gel in Subjects With Palmar Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperhidrosis
Lead sponsor: Botanix Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the safety and local tolerability of BBI-4000 15% gel compared with vehicle (placebo) when applied topically once daily in subjects with palmar hyperhidrosis.

Detailed description: This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Local Tolerability of Topically Applied BBI-4000 (Sofpironium Bromide) 15% Gel in Subjects with Palmar Hyperhidrosis.

Participating subjects will apply either BBI-4000 15% or vehicle gel topically to the palms of both hands once daily for 4 consecutive weeks. The 4 week treatment period will be followed by a 2 week follow-up period.

Safety and tolerability will be assessed through collection of vital signs, adverse events, assessment of local skin responses, ECG, UPT and blood sampling.

Efficacy will be assessed through gravimetric sweat assessments as well as through the Hyperhidrosis Disease Severity Scale (HDSS).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary palmar hyperhidrosis
* HDSS of 3 or 4 at baseline
* Gravimetric test at baseline indicating at least 100 mg of sweat production at rest in each palm and a sum of at least 250 mg in both palms, in 5 minutes (room temperature)
* Symptoms of at least 6 months' duration
* Females of childbearing potential must agree to use a medically acceptable method of contraception while participating in the study

Exclusion Criteria:

* Any skin or subcutaneous tissue conditions of the palms, other than hyperhidrosis
* Prior use of any prohibited medication(s) or procedure(s) within specified timeframe for the treatment of palmar hyperhidrosis, including:

  1. Botulinum toxin to the palmar area within 9 months of baseline visit
  2. Iontophoresis within 30 days of baseline visit
  3. Palmar thermolysis, sympathectomy or surgical procedures of the palmar area any time in the past
  4. Serotonergic agonist within 30 days of baseline visit
  5. Any topical prescription treatment for hyperhidrosis within 30 days of baseline visit
  6. Any over-the-counter topical antiperspirant/deodorant within 7 days of baseline visit
* Use of anticholinergic agents within 30 days of baseline visit
* Any oral or topical homeopathic or herbal treatment within 30 days of baseline visit
* Use of any cholinergic drug within 30 days of baseline visit
* Use of any anti-anxiety and/or anti-depressant, amphetamine products or drugs with known anticholinergic side effects
* Hyperhidrosis secondary to any known cause
* Subjects with history of unstable type 1 or type 2 diabetes mellitus or thyroid disease, history of renal impairment, hepatic impairment, malignancy, glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, benign prostatic hyperplasia (BPH), neurological conditions, psychiatric conditions, Sjögren's syndrome, Sicca syndrome, or cardiac abnormalities that may alter normal sweat production or may be exacerbated by the use of anticholinergics.
* Subjects with known hypersensitivity to glycopyrrolate, anticholinergics, or any of the components of the topical formulation.
* Pregnant or lactating women.
* Use of an investigational drug within 30 days prior to the baseline visit.
* Any major illness within 30 days before the screening examination.

Primary outcomes:
measure: Number of Treatment Emergent Adverse Events by Severity
timeFrame: Baseline visit-Day 42 End of Participation
Secondary outcomes:
measure: Proportion of Randomized Subjects Achieving a 1-grade & 2-grade Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Day 29
timeFrame: Baseline to Day 29 (End of Treatment) Visit
measure: Absolute Change (Day 29 - Baseline) in Palmar Gravimetrically Measured Sweat Production (GMSP) (mg) by Treatment Arm.
timeFrame: Baseline-Day 29 Participation
measure: Comparison of Number Subjects Achieving a Minimum of 50% Reduction in Gravimetrically Measured Sweat Production Day 29-baseline Among Both Treatment Arms
timeFrame: Baseline through day 29 (End of Treatment)
measure: The Percent Change (%) Day 29 Combined GMSP From Baseline Combined GMSP Gravimetrically Measured Sweat Production (GMSP) in Combined (Right and Left) Palms.
timeFrame: Baseline-Day 29 End of Treatment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: TCR Medical Corporation
state: California
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Carmel
country: United States
facility: Shideler Clinical Research Center
state: Indiana
city: Saint Louis
country: United States
facility: Saint Louis University Dermatology
state: Missouri
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
References: