Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users

NCT05501444 | Completed

• 1 other identifier: FoU_2022_Hyperhidrosis
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present pilot study is to evaluate the effect of antiperspirant to treat residual limb hyperhidrosis with the emphasis on the utility of the iodine-starch test to identify the location of the sweating.

Conditions

Hyperhidrosis; Residual Limbs

Keywords

Lower limb amputation; Hyperhidrosis; Prosthetic users; Aluminum chloride; Sweating

Outcome Measures

Primary Outcomes (2)

• Hyperhidrosis Disease Severity Scale (HDSS)

  The HDSS is a short single-item scale that is scored from 1-4 and provides a qualitative measure of the severity of sweating based on the extent to which sweating affects daily activities.

  Four weeks

• Sweating Intensity Visual Scale (SIVS)

  In connection with the Minor test, it is also recommended to use the Sweating Intensity Visual Scale (SIVS) in order to provide a more objective and standardized interpretation of the results of the Minor test. SIVS is graded on a scale from 0-V (Grade 0= minimal or no sweating, Grade I = initial, discrete sweating, Grade II = mild sweating, Grade III = moderate sweating, Grade IV = intense sweating, and Grade V= oversweating)

  Four weeks

Secondary Outcomes (1)

• Numerical Ranking Scale (NRS 100)

  Four weeks

Study Arms (1)

Effect of antiperspirant

EXPERIMENTAL

Aluminium chloride 15 percent

Other: Topical antiperspirant

Interventions

Topical antiperspirant OTHER

The participants will be instructed to use topical antiperspirant (aluminum chloride, 15 percent every evening for four weeks. The PI will contact the participants every week. If the participant experiences that antiperspirant have an effect, the use of antiperspirant will be reduced from daily use to 3 times a week.

Effect of antiperspirant

Eligibility Criteria

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

You may qualify if:

• Over 18 years,
• used a prosthetic for at least 1 year,
• HDSS score of ≥ 2,
• use the prosthetic daily and be able to walk for a minimum of 10 minutes.

You may not qualify if:

• Open wounds on the stump,
• Known sensitivity or allergy to iodine and/or starch,
• Known sensitivity to antiperspirant.

Sponsors & Collaborators

• Sophies Minde Ortopedi: lead

Study Sites (1)

Sophies Minde Ortopdi AS

Oslo, 0667, Norway

Location

MeSH Terms

Conditions

Hyperhidrosis

Interventions

Antiperspirants

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cosmetics; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Jette Schack, PhD

  Sophies Minde Ortopedi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The project is carried out as a pilot study

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 15, 2022
• Study Start: August 9, 2022
• Primary Completion: December 31, 2022
• Study Completion: March 30, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)