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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
189
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States
Therapeutics Clinical Research
San Diego, California, United States
Center for Clinical and Cosmetic Research
Aventura, Florida, United States
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
Time frame: Baseline through Week 4 (Day 29)
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
Time frame: Baseline through Week 4 (Day 29)
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
Time frame: Baseline through Week 4 (Day 29)
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%
Time frame: Baseline through Week 4 (Day 29)
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Placebo, BBI-4000 Gel, 0%
International Dermatology Research, Inc.
Miami, Florida, United States
International Clinical Research
Sanford, Florida, United States
Shideler Clinical Research Center
Carmel, Indiana, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Saint Louis University Dermatology
St Louis, Missouri, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
...and 2 more locations