30 Participants Needed

Polymer Skin Barrier for Sweaty Palms

MD
AA
Overseen ByAdelaide A Hebert, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new topical treatment for individuals with excessive sweating on their hands, known as primary palmar hyperhidrosis. The treatment, called Polymer Skin Barrier, uses a special adhesive to quickly block sweat glands, potentially outperforming current options that take longer to work and often have side effects. Individuals who have experienced sweaty palms for at least six months and find it impacts their daily life might be suitable for this study. The goal is to find a fast, effective, and safe way to manage this condition. As an unphased trial, this study offers a unique opportunity to explore an innovative treatment that could significantly improve daily life for those affected.

Will I have to stop taking my current medications?

You may need to stop certain medications before joining the trial. Specifically, if you are taking medications with systemic anticholinergic activity, centrally acting alpha-2 adrenergic agonists, or beta-blockers, you must have been on a stable dose for at least 4 months. Additionally, you cannot have taken Qbrexza, botulinum toxin, or undergone iontophoresis recently.

What prior data suggests that this polymer skin barrier is safe for treating sweaty palms?

Research has shown that cyanoacrylate (CA) tissue adhesives, the main ingredient in the Polymer Skin Barrier treatment, have been safely used in medical settings for a long time. These adhesives help close wounds and prevent infections. Two types of CA, n-Butyl and 2-Octyl, are commonly used in surgeries and are considered safe. However, some people might experience a skin reaction called allergic contact dermatitis, occurring in about 2.2% to 2.7% of cases when used on surgical wounds. The risk may be lower when applied to healthy skin, as it will be in this treatment.

The treatment is not yet approved as an antiperspirant, but its safety is supported by its long history of medical use. The Polymer Skin Barrier is expected to be affordable and work quickly. It should not harm the skin or affect grip, making it a promising option for those dealing with sweaty palms.12345

Why are researchers excited about this trial?

Researchers are excited about the Polymer Skin Barrier treatment for sweaty palms because it offers a novel approach compared to traditional methods like antiperspirants, iontophoresis, or Botox injections. Unlike these standard treatments, which primarily aim to block or temporarily disable sweat glands, the Polymer Skin Barrier forms a protective layer on the skin's surface, potentially reducing sweat without affecting the underlying glands. This method may offer a less invasive and more convenient daily application, with the potential for quicker results over just a week.

What evidence suggests that this polymer skin barrier is effective for hyperhidrosis?

Research has shown that a special skin barrier, like the topical polymer treatment in this trial, can effectively reduce excessive sweating on the palms. One study found that improving the HDSS score by one point can cut sweat production by 50%, while a two-point improvement can reduce it by 80%. This suggests the treatment could significantly decrease sweatiness. The polymer treatment acts quickly, within seconds, and does not harm the skin or affect grip. Unlike some current treatments, it is affordable and provides fast results, making it a promising option for managing sweaty palms.13678

Who Is on the Research Team?

MJ

Mark J Miller, PhD

Principal Investigator

Miller Biosciences LLC

AA

Adelaide A Hebert, MD

Principal Investigator

UTHealth McGovern Medical School-Houston and Children's Memorial Hermann Hospital-Houston

Are You a Good Fit for This Trial?

This trial is for individuals with excessive sweating of the palms, known as hyperhidrosis. It's suitable for those who haven't had success with standard treatments like antiperspirants or find them irritating. People looking for a fast-acting, non-invasive option may benefit.

Inclusion Criteria

Willing to comply with the protocol
Average sweat severity score of ≥ 3 at Baseline
I have severe sweating that affects my daily activities.
See 5 more

Exclusion Criteria

I have not had iontophoresis for my palms in the last 4 weeks.
Current pregnancy or lactation
Screening clinical chemistry or hematology laboratory value that is considered clinically significant
See 14 more

Timeline for a Trial Participant

Screening/Baseline

Participants are screened for eligibility to participate in the trial

Same day
1 visit (in-person)

Treatment

Participants receive topical cyanoacrylate treatment once or twice daily for one week

1 week
Daily self-administration

Follow-up

Participants are monitored for safety and effectiveness after treatment via phone call and exit survey

4 weeks
1 phone call

What Are the Treatments Tested in This Trial?

Interventions

  • Polymer Skin Barrier
Trial Overview The study tests a topical cyanoacrylate (TCA) polymer film that could quickly block sweat pores and reduce palm sweating without damaging skin texture or grip. This pilot study aims to assess TCA's safety and effectiveness compared to current treatments.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Topical TCA treatment once or twice dailyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Miller Biosciences LLC

Lead Sponsor

Trials
1
Recruited
30+

Citations

A Polymer Film Device to Treat Excessive Palmar SweatingA 1-point improvement in HDSS score has been associated with a 50% reduction in sweat production and a 2-point improvement with an 80% reduction. This tool has ...
Efficacy and Safety of Treatments for Primary Palmar ...However, its efficacy comes at the cost of compensatory hyperhidrosis, which affected up to 94.6% of the patients in some studies [17].
Top Hyperhidrosis Clinical Trials | PowerPolymer Skin Barrier for Sweaty Palms. Perspiration or sweating is a normal physiological response to increased body temperature, environmental heat and ...
A Polymer Film Device to Treat Excessive Palmar SweatingA 1-point improvement in HDSS score has been associated with a 50% reduction in sweat production and a 2-point improvement with an 80% reduction ...
Performance of Polymeric Skin Adhesives during ...Water absorbing skin adhesives were found to have significantly higher peel forces compared to non-absorbing adhesives under sweating conditions where the ...
Polymer Skin Barrier for Sweaty PalmsThis N/A medical study run by Miller Biosciences LLC is evaluating whether Polymer Skin Barrier will have tolerable side effects & efficacy for patients ...
A Polymer Film Device to Treat Excessive Palmar SweatingAlthough n-Butyl and 2-Octyl cyanoacrylate are considered safe, allergic contact dermatitis can occur after surgical wounds closure at an ...
Skin-Interfaced Superhydrophobic Insensible Sweat Sensors ...This work introduces a superhydrophobic sweat sensor based on a polyacrylate sodium/MXene composite sandwiched between two superhydrophobic textile layers.
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