Excessive Sweating (Hyperhidrosis)

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Excessive Sweating (Hyperhidrosis)

General Purpose:

Sweat is our body’s natural way of cooling itself when we start to overheat. Unfortunately for some, their bodies are unable to turn off the sweating mechanism efficiently, and as a result they produce more sweat than they need to cool their body. Excessive sweating can be an extremely troublesome condition for those who suffer from it, and the emotional and social ramifications can take a toll on an individual’s emotional wellbeing and self-esteem.

There are two types of excessive sweating: focal hyperhidrosis and generalized hyperhidrosis. Individuals who suffer from focal hyperhidrosis usually experience excessive sweating on the soles of their feet, the palms of their hands, and their underarms.

Researchers are not exactly certain as to what causes this focal type of excessive sweating; however excessive stress or emotional trauma, as well as genetics have been suggested as potential causal factors.

On the other hand, generalized hyperhidrosis affects widespread areas of the body. For some sufferers, there is no readily identifiable cause; for others, an underlying cause is to blame. Certain medications can lead to excessive sweating as a side effect.

In addition, leukemia, lymphoma, and various infections can also lead to generalized sweating. Widespread and excessive sweating can also be associated with menopause, low blood sugar, and thyroid problems. Regardless of the cause or type of hyperhidrosis, it can be successfully treated with a number of different methods, and research is constantly investigating new and better ways to help patients who suffer from it.  

What Will Excessive Sweating Clinical Trials Be like?

The types of procedures used in hyperhidrosis clinical trials will ultimately depend on the specific nature of the study and what type of hyperhidrosis is being studied. Provided below is a list of common procedures, tests, and assessments that may be incorporated into hyperhidrosis clinical trials:

  • Detailed physical examination
  • A questionnaire or face-to-face interview to provide details related to your history of hyperhidrosis, which may include questions related to the following:
    • Date of onset
    • Noticeable triggers
    • Family history of hyperhidrosis
    • Use of prescription or over-the-counter medications, including vitamins, minerals, and other dietary supplements
    • You may also be asked to avoid wearing lotions, perfumes, colognes, or scented make-up on the day(s) of your appointment.
    • Questionnaires to evaluate your stress level and/or emotional well-being
    • Blood tests
    • Skin biopsy
    • Use of lotions, creams, oral medications, or laser light therapy

Typical Hyperhidrosis Clinical Trial Protocol:

Specific examples of clinical trials for hyperhidrosis might include the following:

  • A randomized trial designed to determine if the use of a drug designed to treat overactive bladder symptoms is effective as a treatment for hyperhidrosis that affects the hands. In such a study, half of the participants would be randomly assigned to receive the drug while the other half would be randomly assigned to receive a placebo. At the end of the study, those patients who received the active drug would be evaluated to determine if the use of the drug resulted in a decrease in their sweating and improvements in their overall quality of life.
  • A clinical trial in which a standard surgical procedure used to treat severe underarm hyperhidrosis is compared to the use of Botox injections to determine which treatment is more effective at reducing the amount of sweating.
  • A clinical trial to determine if a prescription strength antiperspirant applied directly to the underarms is effective at minimizing hyperhidrosis that occurs as a side effect of a particular antidepressant medication.

A brief word about randomized trials and placebos: 

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated (such as the first clinical trial example described above), the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed: 

The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know as many details as possible with regard to your specific circumstances when searching for clinical trials.  Examples of information you may want to have on hand include the following:

  • Your history of excessive sweating
  • Your prior and current diagnoses of any other health conditions or diseases
  • Your current medications (including vitamins, minerals, and other dietary supplements)

Suggested Search Terms:

 “hyperhidrosis treatment,” “hyperhidrosis children,” “hyperhidrosis side effect,” and “hyperhidrosis medication.”

 

Current Search Term:

“Excessive Sweating (Hyperhidrosis)”

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Interventions:   Device: Fractional Micro-Needle Radiofrequency;   Drug: Botulinum toxin type A
Sponsor:   Mae Fah Luang University Hospital
Completed - verified February 2017


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Interventions:   Drug: BBI-4000 Concentration 1;   Drug: BBI-4000 Concentration 2;   Drug: BBI-4000 Concentration 3;   Drug: Vehicle (Placebo)
Sponsor:   Brickell Biotech, Inc.
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Condition:   Primary Axillary Hyperhidrosis
Interventions:   Drug: WO3979;   Drug: WO3970;   Drug: WO3992;   Drug: Placebo (WO3988)
Sponsors:   Dr. August Wolff GmbH & Co. KG Arzneimittel;   Nuvisan GmbH;   FGK Clinical Research GmbH;   Charles River Biopharmaceutical Services GmbH
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Single-Treatment, Study of Percutaneous-Temperature Controlled-RF Electrocoagulation on Axilla Tissue


Condition:   Sweating Increased Armpits
Intervention:   Device: Thermi Radiofrequency
Sponsor:   ThermiGen, LLC
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The Use of Topical Oxybutynin 10% for Treating Primary Focal Hyperhidrosis-axillary, Palmar and Plantar.


Condition:   Hyperhidrosis
Interventions:   Drug: Oxybutynin;   Drug: Placebos
Sponsor:   Tel-Aviv Sourasky Medical Center
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Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis


Conditions:   Hyperhidrosis;   Hyperhidrosis Palmaris et Plantaris
Intervention:   Device: Hydrogel electrode-based iontophoresis
Sponsor:   Stanford University
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Fractionated Microneedle Radiofrequency for Treatment of Primary Axillary Hyperhidrosis


Condition:   Primary Axillary Hyperhidrosis
Intervention:   Device: Fractional microneedle RF(United, Peninsula Medical, China)
Sponsor:   Xijing Hospital
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A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 Gel in Subjects With Palmar Hyperhidrosis


Condition:   Hyperhidrosis
Interventions:   Drug: BBI-4000, 15%;   Other: Vehicle gel
Sponsor:   Brickell Biotech, Inc.
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A Study to Evaluate Clinical Effect, Pharmacokinetics , Safety, and Tolerability of Umeclidinium in Palmar Hyperhidrosis Subjects


Condition:   Hyperhidrosis
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A Pilot Study Exploring the Efficacy and Safety of Topical Oxybutynin 3% Gel for Primary Focal Hyperhidrosis in Adolescents and Young Adults


Condition:   Hyperhidrosis
Intervention:   Drug: Oxybutynin 3% gel
Sponsors:   University of Colorado, Denver;   Society for Pediatric Dermatology
Active, not recruiting - verified February 2017


Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis


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Interventions:   Biological: Botulinum toxin type A;   Biological: Botulinum toxin type A;   Biological: Placebo comparator
Sponsor:   Revance Therapeutics, Inc.
Completed - verified March 2016


Pharmacokinetic, Safety, Tolerability, and Clinical Effect of Topical Umeclidinium in Primary Axillary Hyperhidrosis


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Interventions:   Drug: Umeclidinium;   Drug: Vehicle
Sponsor:   GlaxoSmithKline
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Long-term Safety Study of DRM04 in Subjects With Primary Axillary Hyperhidrosis


Condition:   Hyperhidrosis
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Sponsor:   Dermira, Inc.
Completed - verified August 2016


Study of DRM04 in Subjects With Axillary Hyperhidrosis


Condition:   Hyperhidrosis
Interventions:   Drug: DRM04 Topical Wipes;   Other: Placebo
Sponsor:   Dermira, Inc.
Completed - verified March 2017


Study of DRM04 in Axillary Hyperhydrosis


Condition:   Hyperhidrosis
Interventions:   Drug: DRM04 Topical Wipes;   Other: Placebo
Sponsor:   Dermira, Inc.
Completed - verified March 2017


Miradry Treatment for Focal Axillary Hyperhidrosis


Condition:   Axillary Hyperhidrosis
Intervention:   Device: MiraDry ®
Sponsor:   Sidney Kimmel Comprehensive Cancer Center
Recruiting - verified October 2016


Ulthera® System for Treating Axillary Hyperhidrosis


Condition:   Primary Axillary Hyperhidrosis
Intervention:   Device: Ulthera System treatment
Sponsor:   Ulthera, Inc
Completed - verified November 2016


Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis


Condition:   Hyperhidrosis
Interventions:   Drug: Oxybutynin;   Drug: Placebo
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A Dose-Ranging Study of the Effect of DRM04B in Subjects With Axillary Hyperhidrosis


Condition:   Hyperhidrosis
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Sponsor:   Dermira, Inc.
Completed - verified August 2016


Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis


Condition:   Hyperhidrosis
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Sponsor:   Carl Swartling
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Condition:   Hyperhidrosis
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Sponsor:   GlaxoSmithKline
Completed - verified May 2017


Excessive Sweating Caused by Antidepressants: Measurement and Treatment With Glycopyrrolate (AIDES-G)


Conditions:   Hyperhydrosis;   Depression
Intervention:   Drug: Glycopyrrolate
Sponsor:   Thomas Jefferson University
Terminated - verified August 2016


Excessive Sweating Caused by Antidepressants: Measurement and Treatment With Terazosin


Condition:   Hyperhidrosis
Intervention:   Drug: terazosin
Sponsors:   Thomas Jefferson University;   National Alliance for Research on Schizophrenia and Depression
Completed - verified August 2016

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