A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 Gel in Subjects With Palmar Hyperhidrosis

NCT02682238 | Completed Phase 2 Results

• 1 other identifier: BBI-4000-CL-202
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

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.

Conditions

Hyperhidrosis

Outcome Measures

Primary Outcomes (1)

• Number of Treatment Emergent Adverse Events by Severity

  Each subject counted only once. Severity was rated Mild, Moderate or Severe.

  Baseline visit-Day 42 End of Participation

Secondary Outcomes (4)

• Proportion of Randomized Subjects Achieving a 1-grade & 2-grade Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Day 29

  Baseline to Day 29 (End of Treatment) Visit

• Absolute Change (Day 29 - Baseline) in Palmar Gravimetrically Measured Sweat Production (GMSP) (mg) by Treatment Arm.

  Baseline-Day 29 Participation

• Comparison of Number Subjects Achieving a Minimum of 50% Reduction in Gravimetrically Measured Sweat Production Day 29-baseline Among Both Treatment Arms

  Baseline through day 29 (End of Treatment)

• The Percent Change (%) Day 29 Combined GMSP From Baseline Combined GMSP Gravimetrically Measured Sweat Production (GMSP) in Combined (Right and Left) Palms.

  Baseline-Day 29 End of Treatment

Study Arms (2)

BBI-4000, 15%

EXPERIMENTAL

15% BBI-4000 (sofpironium bromide) topical gel

Drug: BBI-4000, 15%

Vehicle

PLACEBO COMPARATOR

Vehicle (placebo) gel

Other: Vehicle gel

Interventions

BBI-4000, 15% DRUG

BBI-4000, 15%

Vehicle gel OTHER

Also known as: Placebo gel

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Botulinum toxin to the palmar area within 9 months of baseline visit
• Iontophoresis within 30 days of baseline visit
• Palmar thermolysis, sympathectomy or surgical procedures of the palmar area any time in the past
• Serotonergic agonist within 30 days of baseline visit
• Any topical prescription treatment for hyperhidrosis within 30 days of baseline visit
• 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.

Sponsors & Collaborators

• Botanix Pharmaceuticals: lead

Study Sites (5)

TCR Medical Corporation

San Diego, California, 92123, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

Shideler Clinical Research Center

Carmel, Indiana, 46032, United States

Location

Saint Louis University Dermatology

St Louis, Missouri, 63122, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Anthony Robinson, MS, CRNP
• Organization: Botanix Pharmaceuticals

trials@botanixpharma.com

+1 (445) 300-3403

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 15, 2016
• Study Start: March 8, 2016
• Primary Completion: July 14, 2016
• Study Completion: October 4, 2016
• Last Updated: May 19, 2023
• Results First Posted: May 19, 2023

Record last verified: 2023-05

Locations

US (5)