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Hyperhidrosis clinical trials

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NCT ID: NCT04263623 Active, not recruiting - Hyperhidrosis Clinical Trials

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

Start date: January 31, 2020
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group comparison study of AT-5214 in subjects with moderate to severe primary palmar hyperhidrosis (sweaty palms). This study will compare two different oral (tablet) doses of AT-5214 (study drug) versus a matched placebo. Approximately 120 subjects will be enrolled at approximately 10 study sites.

NCT ID: NCT04227691 Enrolling by invitation - Clinical trials for Hyperhidrosis Primary Focal Axilla

Treatment of Axillary Hyperhidrosis With Long-pulsed Nd:YAG Laser or IPL

Start date: January 17, 2020
Phase: N/A
Study type: Interventional

SUMMARY Objective To assess the efficacy of Nd:YAG laser treatment on eccrine sweat production in the axillae of persons experiencing excessive axillary hyperhidrosis. Design Randomised, within-person controlled clinical trial. Setting One Dermatology Department, at a University hospital in Denmark, from 2018-20. Participants A total of 10 participants enrolled after signing informed consent from the patients attending the hyperhidrosis clinic. Interventions Participants will receive one Nd:YAG laser-treatment of either left or right axilla. The treated area will be cooled with ice during and after laser treatment. Prior to treatment, patients can use lidocaine-prilocaine 5% cream at the treatment site on an optional basis. Main outcome measures Primary outcome measure will be reduced excessive sweat production (%points) monitored by an iodine-starch test assessed at 1-month follow-up compared to baseline. A 30% reduction in sweat production in the Nd:YAG laser-treatment relative to control, will be considered clinically significant. Key secondary outcome measures include (1) weighing the sweat by gravimetric testing, (2) patient assessment of sweat production on a Hyperhidrosis Disease Severity Scale (HDSS) - also assessed at 1 month from baseline. Safety around the use of Nd:YAG laser-treatment will be monitored by registering pain during treatment on a visual analogue scale, as well as monitoring of adverse events immediately as well as one week after treatment. As for the purpose of further exploratory analyses (both benefits and harms), all outcome measures will be re-collected 24 months after treatment. Timelines and dissemination For the collection of the primary data (i.e. primary endpoint being assessed after 1 month), First Patient First Visit (FPFV) will take place in November 2018 and Last Patient Last Visit (LPLV) will be in March 2019. The investigators plan to present data internationally at e.g. the European Academy of Dermatology and Venerology as well as nationally to the Danish Dermatology Society and to the Hyperhidrosis Patient Association. Results will be published in an internationally recognised peer reviewed (biomedical) journal. Trial registration: Danish Research Ethics Committee (approved, protocol number: SJ-689); ClinicalTrials.gov: NCT pending (2018-11-22).

NCT ID: NCT04178161 Recruiting - Hyperhidrosis Clinical Trials

Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis

Start date: September 2016
Phase: N/A
Study type: Interventional

Hyperhidrosis is a condition in which sweating is in excess of that required for normal regulation of body temperature. Commonly affected areas in primary hyperhidrosis include axillae, palms and soles. Secondary hyperhidrosis can affect scalp, face, neck, back, groin and legs. Hyperhidrosis can negatively impact, employment, relationships, or other aspects of quality of life. The investigators propose to investigate the use of a unique image-guided laser to specifically ablate eccrine sweat glands.

NCT ID: NCT04159610 Not yet recruiting - Clinical trials for Primary Axillary Hyperhidrosis

Assessment of Safety, Tolerability and Efficacy of 1% GPB Cream Versus Qbrexza® (Glycopyrronium) Cloth 2.4% Under Maximum-Use Conditions in Subjects With Primary Axillary Hyperhidrosis

Start date: July 1, 2022
Phase: Phase 2
Study type: Interventional

The aim of this study is to investigate the safety, tolerability and efficacy of 1% GPB Cream compared to Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use under maximum use conditions.

NCT ID: NCT03948646 Completed - Clinical trials for Axillary Hyperhidrosis

Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302)

CARDIGANII
Start date: December 4, 2020
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 safety and efficacy of sofpironium bromide, 15% gel versus vehicle (2 treatment arms), applied for the treatment of axillary hyperhidrosis.

NCT ID: NCT03921320 Recruiting - Clinical trials for Hyperhidrosis Primary Focal Palms

Compensatory Sweating After Unilateral Sympathectomy on the Dominant Side or Bilateral Sequential Sympathectomy

Universusbi
Start date: March 7, 2019
Phase: N/A
Study type: Interventional

The standard treatment for palmar hyperhidrosis is bilateral sequential thoracic sympathectomy. High rates of compensatory sweating due to the surgical procedure are described in the literature. In the search for a reduction in this side effect, it is possible that unilateral sympathectomy in the dominant side obtains acceptable results and leads to less compensatory sweating with improvement of the quality of life. The aim of this study it to compare the intensity of compensatory sweating due to the standard treatment, that is, bilateral sequential videothoracoscopic sympathectomy in relation to unilateral thoracic sympathectomy on the dominant side.

NCT ID: NCT03880266 Completed - Clinical trials for Palmar Hyperhidrosis

A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis

Start date: February 22, 2019
Phase: Phase 2
Study type: Interventional

The objective of this study is to assess the efficacy and safety of glycopyrronium cloth, 2.4% when used to treat palmar hyperhidrosis.

NCT ID: NCT03840655 Completed - Clinical trials for Palmar Hyperhidrosis

Fluorescent Thoracoscopy Used in Surgery for Palmar Hyperhidrosis

Start date: November 16, 2017
Phase:
Study type: Observational

T3/T4 endoscopic thoracic sympathicotomy is a widely accepted and effective treatment for primary palmar hyperhidrosis. However, sympathetic ganglions are invisible with traditional thoracoscopy and until now, the location of ganglions are confirmed by rib indirectly. The team from thoracic department of Peking University People's Hospital discovered that the sympathetic ganglions can be visualized with fluorescent thoracoscopy. Thus, investigators want to apply fluorescent thoracoscopy in sympathicotomy of palmar hyperhidrosis, to conduct a more precise operation and compare the efficiency of the novel and traditional methods.

NCT ID: NCT03836287 Completed - Clinical trials for Axillary Hyperhidrosis

Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)

CardiganI
Start date: October 9, 2020
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 safety and efficacy of sofpironium bromide, 15% gel versus vehicle (2 treatment arms), applied for the treatment of axillary hyperhidrosis.

NCT ID: NCT03816046 Completed - Hyperhidrosis Clinical Trials

Hyperhydrosis Treatment Using Botulinum Toxin

Start date: May 1, 2018
Phase: Phase 4
Study type: Interventional

The purpose of this study is to describe two safe and reproducible techniques for the treatment of hyperhidrosis using botulinum toxin. The same patient will receive two different injection technique in each armpit and will be evaluated subjectively and objectively.