Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:21 PM
Study NCT ID:
NCT06881394
Status:
RECRUITING
Last Update Posted:
2025-03-18
First Post:
2025-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Polymer Film Device to Treat Excessive Palmar Sweating
Sponsor:
Miller Biosciences LLC
Organization:
Study Overview
Official Title:
A Pilot, Open-Label, Single Site Study Evaluating the Safety and Efficacy of Topical Cyanoacrylate Antiperspirant in Adults With Palmar Hyperhidrosis
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Perspiration or sweating is a normal physiological response to increased body temperature, environmental heat and humidity, emotions, nervousness, or physical exertion. Perspiration occurs when sweat is secreted from sweat glands, travels through sweat ducts and exits sweat pores to coat the skin's surface. The evaporation of sweat from the skin dissipates heat and is the primary thermoregulatory mechanism used by humans and primates. Excessive sweating beyond what is required for maintaining body temperature homeostasis is termed hyperhidrosis. Primary hyperhidrosis is idiopathic affecting the palmar, plantar, axillary, or craniofacial regions bilaterally, while secondary hyperhidrosis is less common and is often a side effect of medication or an underlying pathology. Primary hyperhidrosis may affect up to 4.8% of the US population, yet it is widely underreported and undertreated. Hyperhidrosis can negatively impact daily activities, cause significant stress, limit social interactions, and reduce the quality of life for patients. In particular, excessive palmar sweating interferes with professional activities (e.g., shaking hands, working with tools, or wearing exam gloves) and degrades sports performance.
Hyperhidrosis (HH) is especially difficult to treat on the hands and feet, with clinical care beginning with prescription strength topical aluminum chloride hexahydrate antiperspirants such as DrySol or Secret Clinical, and OTC products (e.g., Carpe). However, prescription strength aluminum chloride antiperspirants are often ineffective, can be irritating and leave a residue that degrades skin texture and grip. Currently, iontophoresis is the only medical device approved for treating palmar and plantar HH, but these devices are expensive (\~$1,500), uncomfortable to use and are time consuming (30 minutes sessions, 3-4 times a week for several months). Oral anticholinergic medicines such as oxybutynin are often prescribed but they have unwanted side effects including blurred vision, dry mouth, and headache. Topical anticholinergic wipes have shown promise, but they are expensive, take weeks to relieve symptoms and have unpleasant side effects in \>18% of patients. Finally, invasive procedures such as Botox™ injections and endoscopic thoracic sympathectomy are used to treat the most severe palmar/plantar HH cases but these treatments are expensive, invasive, painful and can have significant adverse effects including persistent muscle weakness and compensatory sweating. Thus, a high unmet need exists for topical treatments that are fast-acting, safe, and effective.
Cyanoacrylate (CA) tissue adhesives have been used for decades to close wounds, stop bleeding, and prevent infection. CA tissue adhesives bond to the skin through Michael's addition reactions to tissue amines, forming durable but flexible films. Despite CA being used for various medical applications, no CA-based antiperspirants are currently clinically approved or commercially available.
Topical cyanoacrylate (TCA) is based on medical grade cyanoacrylate adhesives with decades of demonstrated safety clinical applications. TCA is cheap to produce which will improve affordability and treatment adoption. In addition, prototypical TCA formulations eliminate surface moisture within seconds and occlude eccrine sweat pores, anticipating a strong antiperspirant effect compared to current treatments which typically reduce sweating with variable efficacy.
TCA is innovative because it is fast acting (acts within seconds) and does not degrade the surface of the skin or grip function. Current hyperhidrosis treatments typically require days to weeks to achieve clinical results, have a variety of undesirable side effects, and can negatively affect the surface feel of the skin. Aside from topical antiperspirants, Botox injections and anticholinergic agents are the only drugs approved by the FDA for treating hyperhidrosis. Due to their rapid polymerization and strong adhesion and low toxicity, n-Butyl and 2-Octly cyanoacrylate are widely used in thoracic, gastrointestinal, neurologic, cardiovascular, ophthalmologic, and vascular surgery. Although n-Butyl and 2-Octyl cyanoacrylate are considered safe, allergic contact dermatitis can occur after surgical wounds closure at an incident rate of 2.7% for 2-Octyl cyanoacrylate and 2.2% for n-Butyl cyanoacrylate, but risks are presumably lower for topical application on intact glabrous skin. Thus, a significant unmet need exists for fast-acting, cheap, effective, and safe treatments that leave the skin with a desirable surface feel and improve grip security.
In this pilot study described in this proposal, investigators will evaluate the safety and efficacy of a topical application of generic cyanoacrylate (TCA, equivalent to FDA cleared GluStich® medical adhesive or Marathon No Sting Liquid Skin Protectant) to inhibit palmar perspiration.
Hyperhidrosis (HH) is especially difficult to treat on the hands and feet, with clinical care beginning with prescription strength topical aluminum chloride hexahydrate antiperspirants such as DrySol or Secret Clinical, and OTC products (e.g., Carpe). However, prescription strength aluminum chloride antiperspirants are often ineffective, can be irritating and leave a residue that degrades skin texture and grip. Currently, iontophoresis is the only medical device approved for treating palmar and plantar HH, but these devices are expensive (\~$1,500), uncomfortable to use and are time consuming (30 minutes sessions, 3-4 times a week for several months). Oral anticholinergic medicines such as oxybutynin are often prescribed but they have unwanted side effects including blurred vision, dry mouth, and headache. Topical anticholinergic wipes have shown promise, but they are expensive, take weeks to relieve symptoms and have unpleasant side effects in \>18% of patients. Finally, invasive procedures such as Botox™ injections and endoscopic thoracic sympathectomy are used to treat the most severe palmar/plantar HH cases but these treatments are expensive, invasive, painful and can have significant adverse effects including persistent muscle weakness and compensatory sweating. Thus, a high unmet need exists for topical treatments that are fast-acting, safe, and effective.
Cyanoacrylate (CA) tissue adhesives have been used for decades to close wounds, stop bleeding, and prevent infection. CA tissue adhesives bond to the skin through Michael's addition reactions to tissue amines, forming durable but flexible films. Despite CA being used for various medical applications, no CA-based antiperspirants are currently clinically approved or commercially available.
Topical cyanoacrylate (TCA) is based on medical grade cyanoacrylate adhesives with decades of demonstrated safety clinical applications. TCA is cheap to produce which will improve affordability and treatment adoption. In addition, prototypical TCA formulations eliminate surface moisture within seconds and occlude eccrine sweat pores, anticipating a strong antiperspirant effect compared to current treatments which typically reduce sweating with variable efficacy.
TCA is innovative because it is fast acting (acts within seconds) and does not degrade the surface of the skin or grip function. Current hyperhidrosis treatments typically require days to weeks to achieve clinical results, have a variety of undesirable side effects, and can negatively affect the surface feel of the skin. Aside from topical antiperspirants, Botox injections and anticholinergic agents are the only drugs approved by the FDA for treating hyperhidrosis. Due to their rapid polymerization and strong adhesion and low toxicity, n-Butyl and 2-Octly cyanoacrylate are widely used in thoracic, gastrointestinal, neurologic, cardiovascular, ophthalmologic, and vascular surgery. Although n-Butyl and 2-Octyl cyanoacrylate are considered safe, allergic contact dermatitis can occur after surgical wounds closure at an incident rate of 2.7% for 2-Octyl cyanoacrylate and 2.2% for n-Butyl cyanoacrylate, but risks are presumably lower for topical application on intact glabrous skin. Thus, a significant unmet need exists for fast-acting, cheap, effective, and safe treatments that leave the skin with a desirable surface feel and improve grip security.
In this pilot study described in this proposal, investigators will evaluate the safety and efficacy of a topical application of generic cyanoacrylate (TCA, equivalent to FDA cleared GluStich® medical adhesive or Marathon No Sting Liquid Skin Protectant) to inhibit palmar perspiration.
Detailed Description:
Protocol TCAAP-PH will investigate TCA use in participants with palmar hyperhidrosis. This is a pilot, open-label, single site study designed to evaluate the safety and efficacy of TCA in participants 18 years of age and older. The study will have a maximum study duration of 4 weeks. This includes screening/baseline, a 1-week treatment period, and a 4 week follow up phone call and exit survey. A total of approximately 30 participants will be enrolled in this study. At the inception of the trial, the age of participants will be 18 years of age or older.
Screening/Baseline will occur the same day to confirm the selection criteria for the study are met. Qualified participants in TCAAP-PH will be selected to receive TCA at this visit. Participants will administer TCA to the affected areas of the palms/fingers daily throughout the treatment period.
This study is being conducted to evaluate the short-term safety and efficacy of TCA dosed up to 1 week of treatment duration. In addition to safety, another objective of this study is to evaluate short-term efficacy in this population. To evaluate the efficacy, response will be assessed based on the hyperhidrosis disease severity scale (HDSS), an instrument that is widely used to assess the severity of palmar hyperhidrosis by the subject that best reflects his or her experience with sweating of the specified body area. Participants are asked "How would you rate the severity of your hyperhidrosis?" (1) My sweating is never noticeable and never interferes with my daily activities (2) My sweating is tolerable but sometimes interferes with my daily activities (3) My sweating is barely tolerable and frequently interferes with my daily activities (4) My sweating is intolerable and always interferes with my daily activities. A score of 3 or 4 indicates severe hyperhidrosis. A score of 1 or 2 indicates mild or moderate hyperhidrosis. A 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 been well accepted and used in multiple palmar hyperhidrosis clinical trials as a reliable and reproducible measure of palmar hyperhidrosis severity. In addition, gravimetric sweat production and grip strength measurements will be used to assess the short-term efficacy in this population. The total sample size for the study is estimated to be approximately 30 participants.
The TCAAP-PH treatment protocol that is being administered to the study intervention group has been used for other indications (e.g. extraoral wound closures and skin protectants) with minimal risk to patients. Due to the low risk profile of cyanoacrylate, the use of this agent for palmar hyperhidrosis will be evaluated with no significant concern regarding the dosage that will be applied to the affected areas. Dosage is 100 µL once per day, which is sufficient to cover the palmar and phalangeal surface of both hands when properly applied. The solution will be applied in the morning after subjects complete their morning meal and washing routine.
The end of the study is defined as the date of the last visit of the last participant in the study. The date of the last visit will be considered the Week 4 phone call.
Screening/Baseline will occur the same day to confirm the selection criteria for the study are met. Qualified participants in TCAAP-PH will be selected to receive TCA at this visit. Participants will administer TCA to the affected areas of the palms/fingers daily throughout the treatment period.
This study is being conducted to evaluate the short-term safety and efficacy of TCA dosed up to 1 week of treatment duration. In addition to safety, another objective of this study is to evaluate short-term efficacy in this population. To evaluate the efficacy, response will be assessed based on the hyperhidrosis disease severity scale (HDSS), an instrument that is widely used to assess the severity of palmar hyperhidrosis by the subject that best reflects his or her experience with sweating of the specified body area. Participants are asked "How would you rate the severity of your hyperhidrosis?" (1) My sweating is never noticeable and never interferes with my daily activities (2) My sweating is tolerable but sometimes interferes with my daily activities (3) My sweating is barely tolerable and frequently interferes with my daily activities (4) My sweating is intolerable and always interferes with my daily activities. A score of 3 or 4 indicates severe hyperhidrosis. A score of 1 or 2 indicates mild or moderate hyperhidrosis. A 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 been well accepted and used in multiple palmar hyperhidrosis clinical trials as a reliable and reproducible measure of palmar hyperhidrosis severity. In addition, gravimetric sweat production and grip strength measurements will be used to assess the short-term efficacy in this population. The total sample size for the study is estimated to be approximately 30 participants.
The TCAAP-PH treatment protocol that is being administered to the study intervention group has been used for other indications (e.g. extraoral wound closures and skin protectants) with minimal risk to patients. Due to the low risk profile of cyanoacrylate, the use of this agent for palmar hyperhidrosis will be evaluated with no significant concern regarding the dosage that will be applied to the affected areas. Dosage is 100 µL once per day, which is sufficient to cover the palmar and phalangeal surface of both hands when properly applied. The solution will be applied in the morning after subjects complete their morning meal and washing routine.
The end of the study is defined as the date of the last visit of the last participant in the study. The date of the last visit will be considered the Week 4 phone call.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: