A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis
Primary Axillary HyperhidrosisHyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of the sweat glands. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 2 study will assess the long-term safety, tolerability, pharmacokinetics and efficacy of sofpironium bromide gel applied topically to pediatric subjects with axillary hyperhidrosis.
Hyperhidrosis in Patients With Amputations-Botox
HyperhidrosisThe objective is to establish and evidence base for hyperhidrosis treatment algorithm in amputees.This project will address a problem that has troubled Service members, Veterans, and civilians with amputations for decades, impacting satisfaction with prosthetic use, residual limb skin health, and negatively affecting quality of life. Prior research in this area has been limited and insufficient. We plan to conduct an open label study of Botox, up to 400 units, to treat limb hyperhidrosis in patients with amputations. The actual dose of Botox used will be based on individual results with the Iodine-Starch test to identify areas on the residual limb that are producing excessive sweat. Botulinum Toxin A (BTX-A): Botulinum toxin therapy is well-established for use in excessive sweating of several body areas (axillary, palmar, plantar, and facial) in individuals with hyperhidrosis and inadequate response to topical treatments. Extensive research has been conducted on the efficacy and safety of BTX-A for hyperhidrosis of other areas, and it has been shown to improve both objective and subjective measures of sweating, and lead to improved quality of life measures. This will be accomplished by completing the following: Test the validity of the Minor iodine-starch test in amputees. Hypothesis: The iodine-starch test is a valid diagnostic tool of hyperhidrosis and can be useful for the identification of focal areas of sweating on a residual limb. Treat the residual limb Hyperhidrosis with Botox, up to and limited to 400 units. Hypothesis: Treatment of residual limb Hyperhidrosis with Botox will result in improved patient reports of excessive sweating as measured by the HDSS and as measured by subjects' response to iodine-starch testing. We are confident that improving the evaluation and treatment of residual limb hyperhidrosis will reduce the secondary health consequences of amputation and will lead to improved quality of life.
Evaluation of N-SWEAT Patch for Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary...
Primary Axillary HyperhidrosisThe Sahara Study is a study to evaluate the safety and effectiveness of the N-SWEAT Patch for use in subjects with excessive axillary sweating, or primary focal axillary hyperhidrosis.
Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis
HyperhidrosisThis is a safety and efficacy study of botulinum toxin type A in subjects with primary axillary hyperhidrosis.
A Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
HyperhidrosisTo 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.
A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 Gel in Subjects With Palmar Hyperhidrosis...
HyperhidrosisTo 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.
Investigation of Hyperhidrosis Treatment Using the Nd: YAG 1440nm Wavelength Laser
HYPERHIDROSISThe purpose of this study is to evaluate the safety and efficacy of the Nd:YAG 1440 nm wavelength laser for the treatment of primary hyperhidrosis of the axilla.
T3 Versus T4 Sympathicotomy for Treatment of Primary Palmar Hyperhidrosis
Compensatory HyperhidrosisRecurrenceT3 versus T4 as a primary treatment for palmer hyperhydrosis and effect on postoperative compensatory hyperhydrosis
Clinical Evaluation of the miraDry System in Subjects With Hyperhidrosis
Axillary HyperhidrosisThe purpose of this study is to determine whether treatment by the miraDry System can safely reduce the severity of axillary hyperhidrosis (excessive underarm sweating).
GSK1358820 (Botulinum Toxin A) PhIII DB & OL Study in Patients With Axillary Hyperhidrosis
HyperhidrosisThe primary objective of this study is to demonstrate superiority of single treatment of GSK1358820 (hereinafter, referred to as BOTOX®) over placebo in terms of the efficacy of treatment with BOTOX® 50 U in each axilla (100 U in total for each patient) as intradermal injections based on gravimetric assessment (measurement of spontaneous axillary sweat production) for axillary hyperhidrosis.