Hyperhidrosis, Developing a Treatment Approach Aims 1 & 2

NCT03416348 | Completed Phase 1 FDA Drug

• 2 other identifiers: OP150030 (Aim 1&2)OP150030
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 2

Brief Summary

The objective is to establish an evidence base for a hyperhidrosis treatment algorithm in amputees. This project will address a problem that has troubled Service members, Veterans, and civilians with amputations for decades, impacting satisfaction with prosthetic use, residual limb skin health, and negatively affecting quality of life. Prior research in this area has been limited and insufficient. The Investigators are confident that improving the evaluation and treatment of residual limb hyperhidrosis will reduce the secondary health consequences of amputation and will lead to improved quality of life. This will be accomplish by completing the following specific aims. Aim 1: Test the validity of the Minor iodine-starch test in amputees. Hypothesis: The iodine-starch test is a valid diagnostic tool of hyperhidrosis and can be useful for the identification of focal areas of sweating on a residual limb Aim 2: Test the effectiveness of a prescription strength topical antiperspirant (Aluminum Chloride 20%) on hyperhidrosis of the residual limb. Hypothesis: Aluminum Chloride will be more effective at controlling sweating than placebo

Conditions

Hyperhidrosis

Keywords

amputation; amputations; sweating; residual limb; service members; civilians

Outcome Measures

Primary Outcomes (1)

• Hyperhidrosis Disease Severity Scale (HDSS)

  The outcome measure of Aim 1 will be measuring the Hyperhidrosis Disease Severity Scale (HDSS). The HDSS is scored on a number scale of 1-4. Score range from 1 (lowest) demonstrating sweating (hyperhidrosis) is least noticeable and does not interfere with daily activities (least impactful) to 4 (highest) sweating is intolerable and interferes significantly with daily activities. This measurement will be completed in a single site visit.

  1 day

Secondary Outcomes (1)

• Hyperhidrosis Disease Severity Scale (HDSS)

  12 weeks

Study Arms (2)

Placebo Comparator AIM 1

PLACEBO COMPARATOR

Aim 1: Demonstration of a strong association of the Sweating Intensity Visual Scale (SIVS) score with the HDSS would provide validation for use of the SIVS in interpreting the iodine-starch test and would establish the value of the iodine-starch test in clinical practice guidelines for diagnosing hyperhidrosis in amputees, just as it is in dermatology practice.

Drug: Aluminum Chloride 20% (deodorant); Drug: Alcohol

Aluminum Chloride vs Placebo in Amputees

ACTIVE COMPARATOR

Aim 2: The investigators will have completed the first clinical trial of Aluminum Chloride for residual limb hyperhidrosis. The investigators will then have a solid foundation of data that demonstrates the rates of adverse effects such as skin irritation, and rates and magnitudes of improvement in subjective and objective measures of sweating.

Drug: Aluminum Chloride 20% (deodorant); Drug: Alcohol

Interventions

Aluminum Chloride 20% (deodorant) DRUG

Aluminum Chloride (deodorant)

Also known as: Drysol, XeracAC

Aluminum Chloride vs Placebo in Amputees; Placebo Comparator AIM 1

Alcohol DRUG

Placebo

Also known as: Ethyl Alcohol

Aluminum Chloride vs Placebo in Amputees; Placebo Comparator AIM 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form (ICF)
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, age 18 or older
• Have a prosthetic device
• In good general health as evidenced by medical history
• If subject is currently using aluminum chloride participant must be discontinued for at least one week prior to participation in the study.

You may not qualify if:

• Open sores or wounds on the residual limb
• Known sensitivity or allergy to iodine
• Known sensitivity to antiperspirant, aluminum chloride hexahydrate

Sponsors & Collaborators

• University of Utah: lead
• US Department of Veterans Affairs: collaborator
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (2)

George E. Wahlen Department of Veterans Affairs Medical Center

Salt Lake City, Utah, 84132-2101, United States

Location

University of Utah

Salt Lake City, Utah, 84132-2101, United States

Location

MeSH Terms

Conditions

Hyperhidrosis

Interventions

Aluminum Chloride; Deodorants; Ethanol

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aluminum Compounds; Inorganic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Cosmetics; Specialty Uses of Chemicals; Chemical Actions and Uses; Alcohols; Organic Chemicals

Study Officials

• Colby Hansen, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: For Aim 1 there will be no masking. Aim 2, recruitment methods will be by convenience sampling. Subjects in Aim 1 reporting an HDSS of 2 or greater and additional subjects as needed from the U of U or VA clinics with HDSS of 2 or greater will be invited to participate in this crossover study. Subjects will be randomized equally to two sequence arms by a random number generator. The first arm will receive in sequential order every 3 weeks: Aluminum Chloride, a placebo of ethyl alcohol base, Aluminum Chloride, and placebo. The second arm will receive in sequential order every 3 weeks: placebo, Aluminum Chloride, placebo, and Aluminum Chloride. Each condition will last for 3 weeks, which will allow enough time for the Aluminum Chloride and placebo to demonstrate their respective effects. The first week of each period will also serve as a sufficient washout for the previous period. The total trial length, then, will be 12 weeks.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: For the two aims of the study, subjects will be recruited from the amputee clinics held at the Salt Lake VA Medical Center or the University of Utah. Combined, these clinics serve approximately 500 patients and see approximately 75 new patients each year. Based on the investigators work, which showed 66% of patients with HDSS scores of 2 or greater, we will have a potential pool of up to 330 eligible patients for the studies that follow. We expect to enroll approximate equal numbers from both sites for each of the aims of this study.

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: January 31, 2018
• Study Start: May 8, 2018
• Primary Completion: January 15, 2022
• Study Completion: February 14, 2022
• Last Updated: October 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)