Clinical trial NCT02336503: A Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperhidrosis
Lead sponsor: Botanix Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-01-13
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Subjects Achieving at Least 2-point Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4
timeFrame: Baseline through Week 4 (Day 29)
Secondary outcomes:
measure: Proportion of Subjects Achieving at Least 1-point Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4
timeFrame: Baseline through Week 4 (Day 29)
measure: Absolute Change in Gravimetrically Measured Sweat Production From Baseline to Week 4 (Day 29)
timeFrame: Baseline through Week 4 (Day 29)
measure: Percent Change in Gravimetrically Measured Sweat Production From Baseline to Week 4
timeFrame: Baseline through Week 4 (Day 29)
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Aventura
country: United States
facility: Center for Clinical and Cosmetic Research
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Sanford
country: United States
facility: International Clinical Research
state: Florida
city: Carmel
country: United States
facility: Shideler Clinical Research Center
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University Dermatology
state: Missouri
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Houston
country: United States
facility: The Center for Skin Research
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: Botanix Pharmaceuticals
name: Patricia Walker, MD PhD
role: STUDY_DIRECTOR
References: