A Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis

Phase 2

Completed

• Conditions: Hyperhidrosis
• Interventions: Drug: BBI-4000 Gel, 5%; Drug: BBI-4000 Gel, 10%; Drug: BBI-4000 Gel, 15%; Drug: Vehicle

• Registration Number: NCT02336503
• Lead Sponsor: Botanix Pharmaceuticals

Brief Summary

To assess the safety and efficacy of 3 doses of BBI-4000 and vehicle (4 treatment arms), when applied once a day for 4 weeks, for the treatment of axillary hyperhidrosis.

Detailed Description

This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 3 concentrations of Topically Applied BBI-4000 in Subjects with Axillary Hyperhidrosis.

Participating subjects will apply BBI-4000 once a day for 4 weeks in their axillae. The 4 week treatment period will be followed by a 2 week follow-up period.

Safety will be assessed through collection of vital signs, adverse events, local skin responses, hematology and serum chemistry laboratory testing and ECGs.

Efficacy will be assessed using the Hyperhidrosis Disease Severity Scale (patient reported outcome) and through gravimetrically measured sweat production.

PK blood samples will be taken from study subjects from selected centers.

Study Timeline

• Study First Submitted: 2015-01-08
• Study First Submitted QC: 2015-01-08
• Study First Posted: 2015-01-13
• Study Start: 2015-03-10
• Primary Completion: 2015-11-05
• Study Completion: 2015-11-05
• Disposition First Submitted: 2018-07-17
• Disposition First Submitted QC: 2018-07-18
• Disposition First Posted: 2018-07-20
• Status Verified: 2022-12
• Results First Submitted: 2022-12-14
• Results First Submitted QC: 2023-02-16
• Last Update Submitted: 2023-02-16
• Results First Posted: 2023-03-15
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

• Primary axillary hyperhidrosis of at least 6 months's duration
• Hyperhidrosis disease severity score of 3 or 4 at baseline
• Gravimetric test at baseline indicating at least 50 mg of sweat production at rest in each axilla, in 5 minutes (room temperature)
• Willing to refrain from using any other antiperspirant agent for the duration of the study.
• Females of childbearing potential must agree to use a medically acceptable method of contraception while participating in the study.

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Exclusion Criteria

• Any skin or subcutaneous tissue conditions in the axilla or near the axillary area, other than hyperhidrosis.

• Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe, including:

  1. Botulinum toxin to the axillary area within 1 year of the baseline visit.
  2. Axillary iontophoresis within 12 weeks of baseline visit.
  3. Axillary thermolysis, sympathectomy or surgical procedures of the axillary area at any time in the past.

• Use of systemic and/or topical anticholinergic treatment within 30 days of the baseline visit.

• Subjects with hyperhidrosis symptoms initiated or exacerbated with their menopause.

• Subjects with history of diabetes mellitus, renal impairment, hepatic impairment, thyroid disease, 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.

• Prior treatment with the study drug in a previous trial.

• Any major illness within 30 days before the screening examination.

• Any other condition or laboratory abnormality that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BBI-4000 Gel, 5%	BBI-4000 Gel, 5%	Low concentration of BBI-4000; BBI-4000 Gel, 5%
BBI-4000 Gel, 10%	BBI-4000 Gel, 10%	Middle concentration of BBI-4000; BBI-4000 Gel, 10%
BBI-4000 Gel, 15%	BBI-4000 Gel, 15%	High concentration of BBI-4000; BBI-4000 Gel, 15%
Vehicle	Vehicle	Vehicle (placebo); BBI-4000 Gel, 0%

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Achieving at Least 2-point Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4	Baseline through Week 4 (Day 29)	Severity is scored with increasing scale, scores 1-4 where minimal severity is scored: 1=My sweating is never noticeable and never interferes with my daily activities and most severe score is: 4=My sweating is intolerable and always interferes with my daily activities

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects Achieving at Least 1-point Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4	Baseline through Week 4 (Day 29)	Severity is scored with increasing scale, scores 1-4 where minimal severity is scored: 1=My sweating is never noticeable and never interferes with my daily activities and most severe score is: 4=My sweating is intolerable and always interferes with my daily activities
Absolute Change in Gravimetrically Measured Sweat Production From Baseline to Week 4 (Day 29)	Baseline through Week 4 (Day 29)	Sweat production unit of measure was weight-based (mg); absolute change was calculated by adding the left and right axillae sweat weights and calculating absolute change by subtracting day 29 from baseline sweat weights
Percent Change in Gravimetrically Measured Sweat Production From Baseline to Week 4	Baseline through Week 4 (Day 29)	Randomized participants that provided samples for gravimetric sweat measures, baseline and day 29; Percent Change was calculated by dividing absolute change by baseline gravimetric measurement x 100%

Trial Locations

Locations (12)

Center for Clinical and Cosmetic Research; 🇺🇸 Aventura, Florida, United States

The Center for Skin Research; 🇺🇸 Houston, Texas, United States

Shideler Clinical Research Center; 🇺🇸 Carmel, Indiana, United States

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States

Academic Dermatology Associates; 🇺🇸 Albuquerque, New Mexico, United States

International Dermatology Research, Inc.; 🇺🇸 Miami, Florida, United States

Center for Dermatology Clinical Research, Inc.; 🇺🇸 Fremont, California, United States

International Clinical Research; 🇺🇸 Sanford, Florida, United States

The Indiana Clinical Trials Center; 🇺🇸 Plainfield, Indiana, United States

Minnesota Clinical Study Center; 🇺🇸 Fridley, Minnesota, United States

Saint Louis University Dermatology; 🇺🇸 Saint Louis, Missouri, United States

Virginia Clinical Research, Inc.; 🇺🇸 Norfolk, Virginia, United States