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What We Learned at the AAD

The Latest Hyperhidrosis-Related Research Results

There was a great hyperhidrosis focus at the American Academy of Dermatology (AAD) Annual Meeting last week. In fact, excessive sweating was the topic of seven research posters and two educational sessions over the four days. You probably saw our blog leading up to this important dermatology conference and could sense our excitement.

As promised, here’s our summary of the hyperhidrosis (Hh) research findings presented at the AAD.

If you’re into digesting the data yourself, awesome! Just visit our Scientific Literature page where we'll post the posters there soon. Check them out and cull your own critical take-aways.

Huge thanks to our board of directors and co-founders and staff -- who co-authored six of these seven research posters, gave presentations, lectures and interviews, and are out in the world representing the needs of hyperhidrosis sufferers.

To start off, below is a summary of the International Hyperhidrosis Society’s (IHhS') findings from the Patient-Focused Drug Development Initiative (PFDD).

10387 – Voice of the Hyperhidrosis Patient: Symptoms, Impacts & Treatments: Insights from a Large, Open, FDA-Attended Meeting

Authors: Adelaide A. Hebert, MD, Dee Anna Glaser, MD, Angela M. Ballard, RN, Lisa J. Pieretti, MBA and David M. Pariser, MD

As our dedicated readers know, PFDDs started as FDA-led meetings but, in order to be able to cover more conditions, they have been expanded to include externally-led PFDDs which FDA representatives provide guidance on and attend.

Both externally-led and FDA-led PFDDs help to systematically gather first-person perspectives on a particular medical condition and currently-available therapies to treat or manage that condition. These perspectives can help key providers, regulators and industry better understand the context of a condition and priorities for care. In other words, PFDD meetings provide an opportunity to hear directly from individuals experiencing a condition (like hyperhidrosis) about the symptoms that matter most to them, the impact the disease has on daily life and experiences with therapeutic options.

The qualitative data in this IHhS research poster came from the International Hyperhidrosis Society-led PFDD meeting held in late 2017, a related poll and comment periods.

The major points:

Hyperhidrosis often starts young: In the PFDD poll, 55% of participants said their Hh started at or before the age of 10 years. Perhaps related, an articulated fear among sufferers (that was repeated often) was that children or grandchildren in the family would also develop the condition.

There are physical impacts of Hh, beyond wetness: Testimonials at the PFDD relayed feelings of being very cold, pain in the hands and/or feet, as well as slips and falls and other accidents.

In terms of social/emotional wellness, we heard about Hh having severe negative social/emotional ramifications: Sufferer testimonials had common refrains of Hh “ruining” life, “controlling” life; feelings of self-harm/suicide, anxiety, isolation, depression. Words PFDD participants used to describe their feelings included: “Doomed”, “Ashamed”, “Outcast”, “Tears”, and “Don’t want to be touched.” (For more on mental health and Hh, see also the summary of poster 8424 below.)

So how are healthcare providers helping hyperhidrosis patients?

Sufferers’ thoughts at the Hh PFDD on the current treatment options being provided or recommended showed that they often feel that there is limited or “no” treatment for non-axillary (non-underarm) Hh, hopelessness with current options, frustration at having “tried everything”, and limited access to care. Testimonials used these words: “Poorly managed”, “Overlooked”, “Undertreated”, and “Make do.”

As an additional heads-up to healthcare providers, in a pre-PFDD poll, IHhS found that 70% of PFDD participants were moderately or extremely dissatisfied with clinical knowledge on Hh, 75% have asked for help with their Hh more than three times, and 95% say their Hh is not resolved.

What did the hyperhidrosis sufferers participating in the PFDD express as desires for their future care? More options, “better” clinical trials, more access to treatments, healthcare providers (like those attending the AAD) who are educated about Hh, and… hope.

For more information, you can read the related white paper and full transcripts from the PFDD (including the meeting transcript and webcast transcript).

8424 – Prevalence of Anxiety, Depression and Attention Deficit Disorder (ADD) in Patients with Primary Hyperhidrosis

Authors: Ella Glaser, Rosemary King, Dee Anna Glaser, MD

At this year’s AAD Annual Meeting, Dr. Dee Anna Glaser (International Hyperhidrosis Society President and Co-founder) reported that she’s noticed something concerning among her hyperhidrosis (Hh) patients over the years.

“Many of them had either anxiety or depression,” she told the AAD. “There were some who had said they had suicidal thoughts because their sweating was ruining their life.”

This led her to conduct research (with her co-authors noted above) in the hope of better understanding the potential connection between mental health and hyperhidrosis. The results were presented at the AAD in the form of a poster presentation.

Key take-home points?

In this study, people with hyperhidrosis were more likely than the general population to have anxiety, depression and/or attention deficit disorder (ADD), regardless of gender or age.

Of the 500 hyperhidrosis patients involved in the study, 13.8 percent had anxiety, 12.4 percent had depression and 6.4 percent had ADD — all rates significantly higher than those reported in the general population. In the results, the severity and/or location of a person’s Hh did not seem to impact the prevalence of anxiety, depression or ADD, but there was a positive correlation between the number of anatomic sites involved and the prevalence of these other concerns.

Dr. Glaser indicated she was most surprised by the association between hyperhidrosis and ADD. “I honestly don’t know what to make of it,” she told the AAD. “I think we need to look into that more and connect with individuals who have experience with ADD and together understand what that link may be.”

In light of these results, Dr. Glaser notes imperatives for healthcare providers caring for hyperhidrosis patients to:

Proactively ask about symptoms of anxiety, depression or ADD

Let patients now that these health concerns, along with hyperhidrosis, can be pretty common, and

Help patients find the care they need from appropriate professionals.

This is especially important, Dr. Glaser noted, among teens and young adults with hyperhidrosis (when the condition usually first manifests). “This population can be vulnerable to mental health conditions,” she said. “Often they feel isolated and feel they’re the only ones with these problems.”

(Special thanks to the American Academy of Dermatology for putting out a press release about this important research and for talking to Dr. Glaser, study co-author and International Hyperhidrosis Society President and Co-founder about these thought-provoking results.)

8213 – Primary Axillary Hyperhidrosis: Do Gravimetric Measurements of Sweat Production Correlate with Disease Severity or Patient Characteristics?

Authors: Mitchell S. Gibbons, Eric Armbrecht, PhD and Dee Anna Glaser, MD

Gravimetric measurement is a method used to record the volume of sweat produced by a patient. This study was designed to help determine if there was a correlation between gravimetric measurements of sweat produced and primary axillary hyperhidrosis disease severity. The authors concluded that a one time gravimetric measurement does not appear to be of significant clinical value in evaluating the disease severity of primary axillary hyperhidrosis.

Why might this be important? Here’s one IHhS view on the subject: Currently, some clinical studies may require participants to achieve a certain gravimetric measurement to participate or may use gravimetric measurements as study endpoints (perhaps to show success, or lack thereof). But if - as this study seems to indicate - gravimetric measurements are not useful in determining Hh severity, perhaps they are not useful as study criteria, either. Our two cents.

9906 – An Evaluation of Anticholinergic Adverse Events with Long-Term Use of Glycopyrronium Cloth, a Treatment for Primary Axillary Hyperhidrosis

Authors: David M. Pariser, MD, Janice Drew, Ramanan Gopalan, Michael Zastrow, Adelaide Hebert, MD

As IHhS readers will likely know, the glycopyrronium cloth treatment for primary axillary hyperhidrosis is currently known by the brand name Qbrexza. It’s a once-per-day treatment applied by patients to the skin of the underarms. This study looked at the the long-term use of the glycopyrronium cloth in order to find out how it was tolerated by patients and what the side effects (if any) might be. The duration of the study was 48 weeks.

Among 550 patients using the glycopyrronium cloth once a day for up to 48 weeks, the authors found the treatment to be “well-tolerated” and with any “treatment-emergent adverse events” (or side effects) being mild or moderate with decreasing incidence over time and infrequently leading to treatment discontinuation. To help with side effects, this study found that decreasing the frequency of cloth use was helpful as was “dose interruption” (taking a break from treatment).

The most common side effects noted in the study, and the percentage of patients experiencing them were:

Dry mouth - 16.9% of patients

Vision blurred - 6.7%

Application site pain - 6.4%

Nasopharyngitis (swelling of the nasal passages and the back of the throat) - 5.8%

Mydriasis (dilated pupils) - 5.3%

Urinary hesitation (trouble starting to urinate or maintaining urine flow) - 4.2%

Nasal dryness - 3.6%

Dry eye - 2.9%

In all, 32% of patients in the study experienced a side effect(s) in the first 4 weeks of treatment. This percentage decreased over time with 27.6% experiencing a side effect(s) from weeks 5 to 12 and 16.2% from week 36 to the end of the study (about 48 weeks). About 8% of study participants stopped using the cloth due to side effects.

Side effects were mild for 45% of patients experiencing them, moderate for 46.5% and severe for 8.5%.

8599 – Glycopyrronium Cloth Improves Axillary Hyperhidrosis Across a Broad Spectrum of Patients: Post Hoc Analyses of the ATMOS-1 and ATMOS-2 Phase 3 Randomized Controlled Trials in Patient Subpopulations

Authors: Dee Anna Glaser, MD, Lawrence Green, Janice Drew, Ramanan Gopalan, Michael Zastrow, David Pariser, MD

In another glycopyrronium cloth (Qbrexza)-related study, authors found that the topically-applied treatment for primary axillary (underarm) hyperhidrosis, when used once per day, reduced sweating severity and sweat production and improved two quality-of-life measures regardless of different patient characteristics including number of other body sites impacted by Hh (keep in mind this treatment was only used for underarms, however), prior Hh treatment, gender, race, age, and body mass index (BMI).

More than 650 patients participated in this study, including: 89 identifying as African American, 5 Asian, 4 American Indian/Alaska Native, 2 Native Hawaiian or other Pacific Islander, and 570 White. There were 44 patients involved who were aged 16 or younger. The number of patients presenting with multifocal Hh was 346 and 53% of participants were female and 47% were male.

9910 – Long-Term Efficacy of Glycopyrronium Cloth in Patients with Primary Axillary Hyperhidrosis

Authors: Edward Lain, Dee Anna Glaser, MD, Ramanan Gopalan, Vincent Yan, Janice Drew, David Pariser, MD

In the third research poster focusing on the glycopyrronium cloth (Qbrexza), researchers set out to learn more about the long-term efficacy of this treatment for underarm excessive sweating. Earlier studies had shown effectiveness in patients using the treatment for just four weeks, so this study gives data regarding the treatment over a much longer time period of patient use (up to 12 times longer).

The research followed patients for about 48 weeks and showed that improvements in quality of life assessments, sweating severity and sweat production continued to be experienced by patients maintaining glycopyrronium treatment. Response to treatment was noted as early as week two. The most common side effect noted in the study was dry mouth, occurring most frequently in the first four weeks of treatment.

10144 – Managing Pitted Keratolysis through hyperhidrosis control with topical glycopyrrolate 2%

Authors: Polytimi Sidiropoulou, Stamatis Gregoriou, Evangelos Balaskas, Eftychia Platsidaki, Vassiliki Tzanetakou, Vasiliki Markantoni, Efimia Agiasofitou, Dimitris Rigopoulos, Georgios Kontochristopoulos

This poster presented three patients who were successfully treated for pitted keratolysis with topical glycopyrrolate 2%. Pitted keratolysis is a bacterial infection of the skin of the feet, most often, but can also impact the hands and can be considered unsightly and produce unpleasant odor. It’s often treated with topical or oral antibiotics, but these authors used a topical glycopyrrolate 2% cream daily for 4 weeks.

Glycopyrrolate, as you may know, is in the class of medicines called anticholinergics. The three male patients in this study all experienced hyperhidrosis of the feet along with pitted keratolysis. After their 4 week treatment, their pitted keratolysis symptoms were improved with “significant regression.” No side effects were reported. Of course, this was a small study with just three patients, so further research on this topic would be useful.

What an inspiring showing regarding hyperhidrosis at the AAD Annual Meeting this year! It should be noted that in addition to the new research results discussed above, our IHhS Secretarty and co-founder (as well as former AAD President) Dr. David Pariser gave the last lecture of the entire meeting (an update on Hh therapeutics) to a full house! Approximately 400 were in the audience. Three cheers for Dr. Pariser for truly getting in the last word with Hh sufferers in mind.

Thanks for reading our research summaries. We hope you’ve learned something! Thanks also to all the researchers for their hard work for the sake of medical science and moving the needle forward.