Treatments in Development
Hyperhidrosis Research and Development
Wondering what hyperhidrosis-related clinical trials are going on and what potential treatments for excessive sweating are in the works?
You’ve come to the right place.
Below you’ll find a summary of what’s happening in hyperhidrosis research and development based on industry pipeline reports, press releases, clinical trials, and more.
All of this information is publicly available, although not from one easily-digestible source. Except here!
TOPICALS APPLIED TO THE SKIN
Topical Glycopyrronium Bromide Cream Treatment Approved in 12 European Countries
In 2022 and 2023 a topical (i.e. applied on top of the skin) cream for underarm hyperhidrosis was approved by European medical governing bodies for use in the following 12 European countries: Italy, Denmark, Latvia, Austria, Sweden, Estonia, Finland, Croatia, Germany, The Netherlands, Norway, and Lithuania.
The treatment is a 1% glycopyrronium bromide-based cream (from the Dr. Wolff Group) to be applied to the affected area twice a week. Glycopyrronium bromide (GPB) is an anticholinergic often used to treat excessive salivation or respiratory secretions, and can be used as an oral treatment for excessive sweating. Glycopyrronium bromide blocks the action of acetylcholine at muscarinic acetylcholine receptors, which are responsible for sweat gland activation, among other things.
According to studies, after eight days of use the cream was able to reduce sweat production so that 60% of treated patients said that their lives were “changed for the better.” Side effects were found to be mild or moderate, temporary, and did not lead to discontinuation of the product; as an example - 9.2% of patients had mild or moderate application site reactions. The most commonly reported side effect was dry mouth (occuring in 16.1% of users).
In related research looking at the use of the 1% GPB cream once daily in patients with moderate or severe primary axillary hyperhidrosis, 57% of the patients had their sweating cut in half using the GPB cream (compared to 34% using the placebo).
A company called Therapeutics, Inc. says it will also conduct a study comparing the safety, tolerability, and efficacy of 1% Glycopyrronium Bromide (GPB) cream (the Dr. Wolff Group product) with that of Qbrexza® (Glycopyrronium) Cloth 2.4% for the treatment of primary axillary hyperhidrosis. The study is not yet recruiting participants.
Botanix’s Sofpironium Bromide Topical Gel May Be Approved Soon
A new topical from Botanix may be approved by the U.S. FDA in mid 2024 for primary axillary hyperhidrosis (underarm excessive sweating). Botanix says it will resubmit its new drug application for the product to the FDA during the first quarter of 2024. Communication to Botanix from the FDA has indicated that no clinical efficacy, safety or manufacturing issues have been raised and no additional clinical studies are required by the FDA to support approval.
The product (sofpironium bromide 15% gel) is an anticholinergic/antimuscarinic drug that blocks sweating at the gland level by binding to a receptor and interrupting the sweat signal. Users apply the gel to the underarms with an applicator that helps prevent the medication from getting on hands by mistake.
A similar product (Ecclock® sofpironium bromide 5%) was approved in Japan and launched by Botanix’s partner Kaken Pharmaceutical Co., Ltd. (See info on that below)
Sofpironium bromide 15% went through two Phase 3 trials in the USA and IHhS is proud to have helped recruit participants for these trials. The two trials (called “Cardigan I” and “Cardigan II”) lasted eight weeks (per participant) and included about 350 hyperhidrosis sufferers each. Study volunteers were aged nine years and older and all were diagnosed with primary axillary hyperhidrosis. As you may know, Phase 3 trials are conducted to confirm and expand knowledge of safety and effectiveness results from Phase 1 and 2 trials and to compare the new product to other standard therapies. Phase 3 trials also look at the overall risks and benefits of a new treatment.
Results showed that more than 60% of study participants had a 50% or greater reduction in sweat production and that 85% of patients using the sofpironium bromide gel experienced a clinically meaningful improvement in their condition. The most common side effects reported were dry mouth and blurred vision. These were usually mild or moderate and temporary. There were no treatment related serious adverse events in any of the studies.
Studies also looked at the use of sofpironium bromide 15% for children aged 9 to 16 suffering from primary axillary hyperhidrosis (underarm excessive sweating). The young people with Hh in this study used sofpironium bromide for more than 5 months with no severe or serious side effects and reported meaningful improvement in their underarm sweating symptoms (an approximately 65% improvement in how they described their sweating severity). Two participants did, however, stop using the skin treatment due to dry eyes, dry mouth, itching, and rash.
IHhS will announce any new treatment approvals to our subscribers and through social media so make sure you are following us on social channels and are on our mailing list.
ECCLOCK® (Sofpironium Bromide 5%) to Launch in Japan and Korea
As mentioned above, Botanix’s partner, Kaken Pharmaceutical Co. Ltd., was approved to market sofpironium bromide at a lower strength (5% concentration) for patients with primary axillary Hh (underarm excessive sweating). Sold under the brand name ECCLOCK®, the product is the first topical prescription product to be approved in Japan for the treatment of primary axillary hyperhidrosis. Kaken also has rights to develop and commercialize sofpironium bromide in Korea, China, and certain other Asian countries. It is expected to be available in Korea soon.
Phase 3 study results for ECCLOCK® were shared as late-breaking research at the 2020 American Academy of Dermatology Virtual Annual Meeting and in the Japanese Dermatological Association’s Journal of Dermatology. In the research, 281 Japanese patients were randomized to either apply sofpironium bromide gel 5% or a placebo gel to their underarms for 42 days. All of the subjects involved in the study had baseline Hyperhidrosis Disease Severity Scale (HDSS) scores of 3 or higher and measurements of sweat production per minute of 50mg or above. At the end of the study, 54% of participants had improved HDSS scores (down to 1 or 2 from previous scores of 3 or more) and 50% reduction in their sweat production measurements (as compared to 36% with placebo.)
Common, mostly mild side effects (occurring in 5% or more of patients) in the sofpironium bromide gel group were nasopharyngitis (cold symptoms, 14.2%), dermatitis (itchy, red or rashy skin) in the underarms (8.5%), and erythema (redness) at the application site (5.7%). Also, a small percentage of those (2.8%) in the treatment group experienced anticholinergic-class side effects such as dry mouth (1.4%), constipation (0.7%), and mydriasis (dilation of the pupils of the eye) (0.7%).
Topical Oxybutynin Cream Studied in Israel & Spray Version Researched Brazil
A small study in the journal Acta Dermato-Venereologica indicates that a gel containing anticholinergic oxybutynin (10%) is safe and effective in treating hyperhidrosis when used twice a day.
Sixty patients with underarm, palmar (hand), or plantar (foot) excessive sweating participated in the research in Israel. Seventy-four percent of the participants reported moderate-to-high satisfaction with the treatment. Quality of life scores among those using the treatment improved by more than one-third. No dry mouth, blurry vision, urine retention, or constipation was reported (side effects that can often be seen with anticholinergics). Two participants did withdraw from the study due to skin itching and redness. Four said that the gel felt “sticky” and was hard to use. More information is needed about this potential treatment. We’ll keep an eye on it and provide more info when it’s available.
Interestingly, there is another clinical trial in the planning stages looking at topical oxybutnynin (10%) applied as a spray (2 puffs/twice a day) for underarm excessive sweating. The spray will be compared to a placebo spray and to oral oxybutnyin (2.5mg/twice daily increasing to 5mg/twice daily). The study will be conducted in Sao Paulo, Brazil by the Science Valley Research Institute but is not yet recruiting patients.
Info on Potential Qbrexza Use Beyond Underarms
IHhS is often asked whether Qbrexza clothes or wipes can be used on other hyperhidrosis body sites, in addition to the underarms.
Here is what we know so far:
- A study published in the Journal of Drugs in Dermatologyogy looked at how Qbrexza might be absorbed through membranes of different thicknesses approximating the skin of different body areas, including that of the hands, feet, underarms, and abdomen. Note that this was a laboratory-based (in-vitro) study, not a study conducted on real people. Results showed that delivery of Qbrexza’s active ingredients through the “skin” of hands and feet could potentially be up to 40-times lower than delivery through underarm or abdominal “skin,” but covering the surface with a material while the medication was being absorbed could help.
- In terms of the active ingredient in Qbrexza (topical 2% glycopyrrolate) and its use off-label for head/face excessive sweating. In 2022, researchers compared topical 2% glycopyrrolate with botulinum toxin A (Botox) injections for the treatment of facial hyperhidrosis. They found that both modalities showed complete response in 75% of cases, but with a longer duration of action in the botulinum toxin group (up to 6 months). Side effects were minor and temporary. The researchers concluded that topical glycopyrrolate 2% showed comparable results to botulinum toxin A in facial Hh treatment with faster onset (an no needles), but shorter duration of effect.
- IHhS co-founder and board member, Dr. David Pariser has led research on the best technique for the use of Qbrexza off-label for palmar (hand) hyperhidrosis. The study compared four different ways of using Qbrexza to manage palm sweating. Results were published in the May 2022 edition of Journal of Drugs in Dermatology. Details of the results are below:
One hundred and twenty patients, age nine years or older with self-reported excessive palm sweating took part in the study, which lasted four weeks and consisted of one of four different daily palmar Qbrexza application routines. The study found that the application of the Qbrexza cloth onto both hands (until the cloth was dry, or about 3 minutes), then wearing clean cotton gloves for 30 minutes, and then washing the hands achieved the best sweat-reducing results with the most acceptable safety profile. For this group, “hand sweat severity” dropped an average of 4 points out of a 10-point scale. To learn more about this research, read our blog or the full study.
Remember, Qbrexza is currently only FDA-approved for the underarms, and is NOT meant to be occluded for the underarms. Be sure you know Qbrexza's underarm directions for use.
Qbrexza to Become Available in Japan
In more Qbrexza news, the Japanese company Maruho licensed Qbrexza and obtained manufacturing and marketing approval in Japan for the product as a treatment for primary axillary (underarm) hyperhidrosis. In May 2022, Maruho launched the product under the brand name "Rapifort® Wipes 2.5%". Maruho reports that primary axillary hyperhidrosis in Japan affects approximately 5.75% of the population (or about 7.5 million people).
In September 2023 Maruho entered into an exclusive license agreement with Journey Medical Corporation (the makers of Qbrexza) to market the product in South Korea, Taiwan, Hong-Kong, Macau, Thailand, Indonesia, Malaysia, Philippines, Singapore, Vietnam, Brunei, Cambodia, Myanmar and Laos.
Work Stops on Combo Oral Medication for Hyperhidrosis
Dermavant Sciences, a biopharmaceutical company based in Long Beach, Calif. was working on an oral treatment for primary multifocal hyperhidrosis that was a combination of the medications oxybutynin and pilocarpine. The product candidate, called DMVT-504 (previously known as THVD-102) had finished Phase 1 trials. (Phase 1 trials are the first trials done with people to test a potential new treatment and to help determine its safety. Phase 1 trials also aim to find the most effective dose of a new drug, balanced with the fewest side effects.)
The oral medicine oxybutynin can already be prescribed to treat hyperhidrosis, but it is not FDA-approved for this indication (rather, it’s used “off label”). Oxybutynin, alone, can have side effects like dry mouth that limit its long-term practicality.
DMVT-504 combined oxybutynin with a delayed-release version of another oral med called pilocarpine. Pilocarpine was added to combat oxybutynin’s possible side effects. In other areas of medicine, pilocarpine is used to help manage dry mouth among cancer patients undergoing radiation therapy, dry mouth related to Sjögren’s syndrome, and increased eye pressure in glaucoma patients. It’s also sometimes used to help with severely dry eyes in people with Sjögren’s.
In a study of DMVT-504 as a treatment for primary focal hyperhidrosis on different/multiple body areas, DMVT-504 was shown to significantly decrease sweating without the dry mouth side-effects that occurred when oxybutynin was taken alone.
Unfortunately, in the summer of 2022, Dermavant discontinued development of DMVT-504 for hyperhidrosis. The company has not indicated its rationale.
A Different Oral Medicine Being Studied for Palmar Hyperhidrosis
Atacama Therapeutics (Wellesley, MA) has a clinical trial for palmar Hh listed here. The trial is looking at two different oral doses of AT-5214 (an anticholinergic called dexmecamylamine HCl) versus placebo in patients with severe primary palmar hyperhidrosis (sweaty palms). Dexmecamylamine HCl is a single isomer of mecamylamine that inhibits α3β4 nicotinic receptors and is a nicotine acetylcholine antagonist. No results of this study have been released yet.
Brella™ SweatControl™ Patch Received FDA Cleared in April 2023
In April of 2023 Candesant Biomedical of San Francisco, Calif. Received FDA-clearance for its device (the Brella™ SweatControl™ Patch) that uses “targeted alkali thermolysis” (TAT) to help treat underarm excessive sweating (axillary hyperhidrosis). TAT is based on the principle that heat is generated when sodium meets water. The result is that when the Brella™ sodium patch is applied to the underarm, there’s an interaction between the water in sweat and the sodium in the patch that generates a targeted amount of heat, causing microthermal injury to the sweat glands that inactivates those glands for a period of time. The process is non-invasive and does not involve needles. The patch, one per underarm, is applied in a medical office for three minutes and delivers a dose of heat precisely to the sweat glands.
In research, Candesant found that the patch “in-activated” sweat glands and reduced sweating for about 3-4 months. Sweat production decreased by more than 50% for most (60%) of treated patients. The most common side effect was temporary, mild redness or irritation. These side effects, said Candesant, were “well-tolerated.” Eighty percent of people in studies had no side effects at all.
Candesant’s pipeline also includes similar products in development for palmar (hand) hyperhidrosis, plantar (foot) and facial hyperhidrosis. For these other indications, the “preclinical” stage is complete and Candesant has reached the “feasibility” stage. We’re keeping our ears and eyes open for updates and will keep our subscribers updated.
How Well to Electrode Pads Work for Iontophoresis?
At Stanford University, a small study looked at the management of palmar hyperhidrosis with hydrogel electrode pads (rather than tap water baths) to deliver iontophoresis treatment in 13 patients. The study is complete but results have not yet been published. As you may know, electrode pads for iontophoresis treatment of the underarms (and other body locations) are already available. We’d be very interested in the results of this study as they would advance understanding of whether this type of iontophoresis is useful for the hands. We'd love the researchers to release their results soon!
Treating Excessive Sweating in Amputees for Better Prostheses Functionality
Medical scientists in France have been studying treatments for residual limb hyperhidrosis among amputees. The French research compared treatment with topical aluminum chloride (the ingredient in many prescription antiperspirants) versus botulinum toxin A injections for the treatment of lower limb excessive sweating, at the amputation site/stump in the amputee population. The study is complete but results are not yet published.
Treating hyperhidrosis among amputees is a topic that’s important for patient quality of life and for the ability of a person to be able to have a well-functioning prosthetic limb - so they can be mobile, work, recreate, socialize, and more. But it's often not talked about. For a deep dive on best practices in treating hyperhidrosis among amputees so that prosthetic limbs can fit and function optimally, please watch our blog, we will be writing about this in January 2024.
Healthcare providers who are interested in this area of critical work, please join us at our annual Master Class educational event where we will cover best practices in caring for excessive sweating of the residual limb in detail! The event is Dec. 7, 2023 in Washington DC.
A Different Botulinum Toxin Studied in Korea
In Korea, researchers at a company called Medy-Tox studied a different type of botulinum toxin type A known as Meditoxin/Neuronox as a treatment for underarm excessive sweating. The results were published in the journal Aesthetic Plastic Surgery and showed that treatment with Neuronox produced statistically significant improvement in underarm sweating symptoms with no serious adverse events.
Another study in Korea focused on the use of Meditoxin/Neuronox versus Botox as a treatment for upper back sweating among men. The study is complete but we are awaiting the publication of the results. We'll share them once they are available.
Can Different Botulinum Toxin Injection Techniques Help to Improve Patient Comfort?
At St Joseph University in Beirut, Lebanon, researchers compared two different techniques for the treatment of underarm hyperhidrosis using botulinum toxin and looked at whether one is more comfortable for patients than the other. The techniques studied were: Technique 1 - “The ‘quadrant’ technique: 5 vertical lines and 5 horizontal lines drawn on the hair-bearing area of the armpit amounting to 25 injection points with more of the points concentrated in the center. Each injection provided ~5 units of botulinum toxin. Technique 2 - “The ‘six injection’ technique: 6 injections in the hair-bearing area equally spaced with each provided ~8 units of botulinum toxin.” Results have been published but are not easily accessible to the public. When we are able to access them, we will share them here.
Lasers for Potential Treatment of Hyperhidrosis
At Massachusetts General Hospital in Boston, experts are looking at the use of image-guided lasers to ablate (destroy) eccrine sweat glands (the glands that produce more watery sweat) of the palms. This is particularly interesting because while lasers are sometimes used to treat excessive sweating of the underarms, using lasers for palm sweating is not common. Patients involved in the study will have one palm treated with the lasers and the other not treated for easy comparison. The lasers to be used are from the company Sciton and the clinical trial is still recruiting participants. Use this link to find contact information in Boston.
In Denmark, the Zealand University Hospital also looked at the treatment of hyperhidrosis with lasers. The Danish study, however, focused on underarms. Results were published in 2023 in the journal Lasers in Surgery and Medicinecine. The study found that one treatment with an external 1064 nm Nd:YAG laser or 640 nm IPL at commercially available settings, was not effective in treating primary axillary (underarm) hyperhidrosis.
Ultrasound for Underarm Excessive Sweating
The company Merz investigated the use of its Ulthera System (which employs ultrasound energy) to treat underarm excessive sweating. We have seen dermatology practices offering this as an option for underarm excessive sweating treatment. This article (from 2014) and another (from 2019) indicate that the option is a safe, effective, well-tolerated, and long-lasting means for treating axillary hyperhidrosis. Merz has not published the results of their study yet, but we will update this page if/when they do.
Compensatory Sweating with Different Types of ETS Surgery
In Brazil, researchers are looking at the intensity of compensatory sweating after ETS surgery for palmar hyperhidrosis. Specifically, the University of Sao Paulo-sponsored study is comparing two different ETS techniques (“unilateral sympathectomy on the dominant side” and “bilateral sequential sympathectomy”) to see if one of them (unilateral sympathectomy on the dominant side) can obtain acceptable results with less compensatory sweating and greater improvement in quality of life. The study is recruiting participants through seven hospitals in Brazil and hoping to include 200 patients in total. The study is estimated to be completed in 2023 but could go longer. IHhS will be keeping an eye on this and providing updates here.
GENERAL HYPERHIDROSIS RESEARCH
Patient Characteristics and Hyperhidrosis Treatment
What do patient characteristics have to do with hyperhidrosis treatment? Researchers at St. Louis University have been trying to find out. Approximately 40 hyperhidrosis patients participated in this study for more than 18 months. Measurements included: weeks until response to treatment, number of treatment changes, the percent reduction in sweat measurements, and disease impact. The study is closed but results aren’t public yet. We'll provided updates as info become avaialble.
Hyperhidrosis Research & Development Needs All of Us
Keeping up with hyperhidrosis research and treatment development takes hyperhidrosis awareness to an advanced level – showing the sophistication of you (our readers) and the progress we’re making to continue to get this serious medical condition taken seriously by the general public, healthcare providers, treatment developers, and investors.
This info is provided so you’re up-to-date on research related to hyperhidrosis. It's all publicly available, although only in one easily-digestible through us.
IHhS notifies subscribers of updates on hyperhidrosis treatments in development, research, or regulatory approvals as soon as we can. Subscribe to our alerts and blogs and make sure you don’t miss anything.
The research described here is a drastic improvement compared to the dearth of investment in hyperhidrosis that existed when the International Hyperhidrosis Society was formed in 2003. You’ve been with us all along, making noise, demanding action, and inspiring the search for solutions. Keep it up! It’s paying off! We’re so glad you’re part of this important work. Thank you and please donate to the IHhS so we can keep this work going.
Do You Want to Help with Hh Research?
For Hh sufferers, getting involved in research can be a potential path to treatment and a satisfying way to give back to the excessive sweating community. To better understand the basics of clinical trials, click here.
For researchers and organizations conducting clinical, market, or educational research, the International Hyperhidrosis Society is here to help you find participants for studies. Whether your search is targeted or broad, get in touch to learn how we can make the process smooth, efficient, and successful. Making connections across the miles, across disciplines, and across the bench is central to what we do.
Motivated to read the latest medical journal articles and study outcomes related to hyperhidrosis so you’re totally in the know? Or, just want to catch up on the headlines of what’s happening in the world of sweat research? Be sure to visit the Published Scientific Research section on this website where we curate the most timely and relevant peer-reviewed pieces for you. Support the International Hyperhidrosis Society so we can keep it coming.