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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.
Full description
This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Local Tolerability of Topically Applied BBI-4000 (Sofpironium Bromide) 15% Gel in Subjects with Palmar Hyperhidrosis.
Participating subjects will apply either BBI-4000 15% or vehicle gel topically to the palms of both hands once daily for 4 consecutive weeks. The 4 week treatment period will be followed by a 2 week follow-up period.
Safety and tolerability will be assessed through collection of vital signs, adverse events, assessment of local skin responses, ECG, UPT and blood sampling.
Efficacy will be assessed through gravimetric sweat assessments as well as through the Hyperhidrosis Disease Severity Scale (HDSS).
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Inclusion criteria
Exclusion criteria
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:
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.
Pregnant or lactating women.
Use of an investigational drug within 30 days prior to the baseline visit.
Any major illness within 30 days before the screening examination.
Primary purpose
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Interventional model
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50 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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