What is this study trying to find out about palmar hyperhidrosis?

This study is evaluating a topical cyanoacrylate polymer as a treatment for excessive sweating of the palms. Researchers want to see if the treatment is safe and reduces sweat production quickly without harming the skin. The study is sponsored by Miller Biosciences LLC and aims to provide a new option for people affected by this condition.

Who may be eligible for this palmar hyperhidrosis clinical trial?

Adults aged 18 years or older with primary palmar hyperhidrosis lasting at least 6 months and experiencing severe sweating may be eligible. Both males and non-pregnant females can participate, provided they are willing to follow study rules. Please review eligibility criteria for more details.

Is there any cost to participate in this palmar hyperhidrosis clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants can expect to receive treatment and monitoring without charge.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06881394

A Pilot, Open-Label Study Evaluating Safety and Efficacy of Topical Cyanoacrylate Antiperspirant in Adults With Palmar Hyperhidrosis

Led by Miller Biosciences LLC · Updated on 2025-03-18

Participants Needed

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

Excessive sweating, known as hyperhidrosis, is a condition where the body produces more sweat than needed to regulate temperature. This affects daily life, causing stress and limiting social and professional activities, especially when it occurs on the palms. Primary palmar hyperhidrosis has few effective treatment options, with current choices often causing discomfort, side effects, or high costs, highlighting a need for better solutions. This pilot study aims to evaluate a topical cyanoacrylate TCA antiperspirant as a new treatment option for adults with palmar hyperhidrosis. Participants will apply a cyanoacrylate polymer topically to the palms once or twice daily for one week. This polymer forms a flexible film over sweat pores, potentially reducing sweating quickly without damaging skin or grip. The study is open-label and single-site, involving about 30 adults aged 18 and older. After baseline screening, participants will use the treatment daily and be monitored for safety and sweat reduction effects over a total of four weeks, including a follow-up phone call. During the study, researchers will assess sweating severity using the Hyperhidrosis Disease Severity Scale HDSS, measure sweat production, and test grip strength. Participants will complete daily sweat severity ratings, and safety will be monitored throughout. The main goal is to see if the treatment safely reduces sweating severity and improves hand function. The study concludes with a phone survey at four weeks to gather final data on treatment effects and participant experience.

CONDITIONS

Brief Title

A Polymer Film Device to Treat Excessive Palmar Sweating

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Signed informed consent
Age 18 years or older
Willing to comply with the study protocol
Male or non-pregnant, non-lactating female
Primary palmar hyperhidrosis for at least 6 months
Average sweat severity score of 3 or higher at baseline
Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4 at baseline
For females of childbearing potential, willing to use accepted birth control during and 30 days after treatment
For males, vasectomized or agree to use birth control during and 7 days after treatment

You will not qualify if you...

Use of Qbrexza (glycopyrronium) within 4 weeks before baseline
Prior surgery for hyperhidrosis
Iontophoresis treatment for palms within 4 weeks before baseline
Botox or botulinum toxin treatment for palms within 6 months before baseline
Participation in experimental therapy within 30 days or 5 drug half-lives before baseline
Recent change or start of psychotherapeutic medication within 2 months before baseline
Use of systemic anticholinergic or certain cardiovascular medications within 4 weeks before baseline unless stable for 4 months
Use of glycopyrrolate or other systemic anticholinergic medications within 4 weeks before baseline
Current pregnancy or breastfeeding
Open wounds or skin conditions on hands affecting skin barrier
Secondary hyperhidrosis or underlying conditions causing sweating
Significant abnormal lab results if medically necessary
History of Sjogren's or Sicca syndrome
History of glaucoma, inflammatory bowel disease, toxic megacolon, febrile illness, paralytic ileus, unstable cardiovascular conditions, severe ulcerative colitis, or myasthenia gravis
History of serious heart rhythm disorders
Poor medical risk due to systemic diseases or infections
Known or suspected allergy to cyanoacrylates

Research Team

Maria D Lopez, MBA

Adelaide A Hebert, MD

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