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

Hyperhidrosis Clinical Trial

Official title:

A Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Effect on Sweat Production of 3 Concentrations of Topically Applied BBI-4000 in Subjects With Axillary Hyperhidrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02336503
• Other study ID #: BBI-4000-CL-201
• Status: Completed
• Phase: Phase 2
• Start date: March 10, 2015
• Est. completion date: November 5, 2015

Study information

• Verified date: December 2022
• Source: Botanix Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: November 5, 2015
• Est. primary completion date: November 5, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Hyperhidrosis

Intervention

Drug:
• BBI-4000 Gel, 5%
BBI-4000 Gel, 5%
• BBI-4000 Gel, 10%
BBI-4000 Gel, 10%
• BBI-4000 Gel, 15%
BBI-4000 Gel, 15%
• Vehicle
Placebo, BBI-4000 Gel, 0%

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	Center for Clinical and Cosmetic Research	Aventura	Florida
United States	Shideler Clinical Research Center	Carmel	Indiana
United States	Center for Dermatology Clinical Research, Inc.	Fremont	California
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	The Center for Skin Research	Houston	Texas
United States	International Dermatology Research, Inc.	Miami	Florida
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	The Indiana Clinical Trials Center	Plainfield	Indiana
United States	Saint Louis University Dermatology	Saint Louis	Missouri
United States	Therapeutics Clinical Research	San Diego	California
United States	International Clinical Research	Sanford	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Botanix Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects Achieving at Least 2-point Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4	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	Baseline through Week 4 (Day 29)
Secondary	Proportion of Subjects Achieving at Least 1-point Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4	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	Baseline through Week 4 (Day 29)
Secondary	Absolute Change in Gravimetrically Measured Sweat Production From Baseline to 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	Baseline through Week 4 (Day 29)
Secondary	Percent Change in Gravimetrically Measured Sweat Production From Baseline to Week 4	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%	Baseline through Week 4 (Day 29)