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Hyperhidrosis clinical trials

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NCT ID: NCT03694093 Completed - Hyperhidrosis Clinical Trials

Assessing the Effect of Patient Characteristics on Treatment Response in Primary Hyperhidrosis

Start date: August 20, 2018
Phase:
Study type: Observational

This study will describe the treatment of hyperhidrosis (excessive sweating) in clinical practice and explore the effect of patient characteristics on treatment response. This study will follow 200 people with hyperhidrosis over 18 months. Anyone with primary hyperhidrosis (excessive sweating not due to another medical condition) over the age of 12 may participate. Study participants will have multiple office visits during which they will asked to rate the severity of their sweat production in multiple areas (i.e. underarms, hands, feet), answer a questionnaire regarding their disease and treatment, and undergo a non-invasive measurement of sweat production called gravimetry. Gravimetry is performed by placing absorbent material in an area, such as the underarms, for a set amount of time and then measuring the amount of sweat collected. In between clinic visits, study participants will be contacted electronically to answer several questions regarding their disease and treatment.

NCT ID: NCT03658616 Completed - Clinical trials for Primary Axillary Hyperhidrosis

Assessment of Efficacy and Safety of Topical Administration of 1% Glycopyrronium Bromide (GPB) in Patients With Primary Axillary Hyperhidrosis and the Assessment of Long-term Efficacy and Safety of Topical Administration of 1% GPB Cream in Patients With Primary Axillary Hyperhidrosis.

Start date: September 18, 2018
Phase: Phase 3
Study type: Interventional

The aim of this study is to investigate the efficacy and safety of 1% GPB cream after 4 weeks of treatment compared with placebo with a sufficient number of patients to obtain statistically significant results, and to assess the long-term safety of 1% GPB cream.

NCT ID: NCT03647982 Completed - Hyperhidrosis Clinical Trials

Anhidrotic Area and Safety of MEDITOXIN in Healthy Male Valunteers

Start date: March 20, 2018
Phase: Phase 1
Study type: Interventional

To determine the anhidrotic area and safety of MEDITOXIN

NCT ID: NCT03627468 Completed - Clinical trials for Primary Axillary Hyperhidrosis

A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis

Start date: September 5, 2018
Phase: Phase 3
Study type: Interventional

Hyperhidrosis 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. Current therapies have limited effectiveness, significant side effects, and can be invasive and costly. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 3 study will assess the long-term safety, tolerability, and efficacy of sofpironium bromide gel applied topically to subjects with axillary hyperhidrosis.

NCT ID: NCT03433859 Completed - Hyperhidrosis Clinical Trials

Topical Aluminium Chloride vs OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)

SALUTOX
Start date: March 2016
Phase: Phase 3
Study type: Interventional

The aim of this study is to demonstrate onabotulinumtoxinA superiority to aluminium chloride for the treatment of residual limb hyperhidrosis.

NCT ID: NCT03416348 Completed - Hyperhidrosis Clinical Trials

Hyperhidrosis, Developing a Treatment Approach Aims 1 & 2

Start date: May 8, 2018
Phase: Phase 1
Study type: Interventional

The objective is to establish an evidence base for a 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. The Investigators 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. This will be accomplish by completing the following specific aims. Aim 1: 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 Aim 2: Test the effectiveness of a prescription strength topical antiperspirant (Aluminum Chloride 20%) on hyperhidrosis of the residual limb. Hypothesis: Aluminum Chloride will be more effective at controlling sweating than placebo

NCT ID: NCT03404570 Completed - Clinical trials for Palmar Hyperhidrosis

Exploratory Study to Assess the Efficacy and Safety of TC-5214 in the Treatment of Subjects With Palmar Hyperhidrosis

Start date: December 21, 2017
Phase: Phase 2
Study type: Interventional

This is a pilot exploratory study to evaluate the safety and efficacy of TC-5214 in subjects with palmar hyperhidrosis.

NCT ID: NCT03320096 Completed - Clinical trials for Axillary Hyperhidrosis

Evaluation of the Ulthera System for Treating Axillary Hyperhidrosis

ULT-218
Start date: December 13, 2016
Phase: N/A
Study type: Interventional

To evaluate the Ulthera System and the 7-3.0mm transducer for treating axillary hyperhidrosis.

NCT ID: NCT03236012 Completed - Hyperhidrosis Clinical Trials

Hyperhidrosis in Patients With Amputations-Botox

Start date: January 8, 2019
Phase: Phase 1
Study type: Interventional

The 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. 1. 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. 2. 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.

NCT ID: NCT03203174 Completed - Hyperhidrosis Clinical Trials

The Use of Microneedles With Topical Botulinum Toxin for Treatment of Palmar Hyperhidrosis

Start date: January 2015
Phase: Phase 1
Study type: Interventional

Hyperhidrosis or sweating of palms results from the overactivity of sweat glands and leads to psychosocial impairment with reduction in quality of life in those that are affected. Injection of botulinum toxin has been shown to be effective in reducing the symptoms of hyperhidrosis with associated improvement in quality of life, but is usually very painful. Microneedles are a different modality for transdermal drug penetration without the pain. This study aims to understand if botulinum toxin A can be delivered topically after microneedle pretreatment in hopes of developing a minimally painful treatment protocol for treatment of palmar hyperhidrosis.