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CompletedNCT05501444Updated Apr 13, 2023

Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users

An interventional study of Topical antiperspirant in Hyperhidrosis and Residual Limbs, sponsored by Sophies Minde Ortopedi. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-13.

Sponsored by Sophies Minde Ortopedi · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Many persons with lower limb amputation report that they have major problems with sweating (hyperhidrosis) on the stump in connection with prosthetic use. Despite the frequency and the negative effect of sweating for prosthetic users, there is a lack of evidence on how the sweating should be examined and treated. In the dermatological literature, the guidelines recommend the use of topical antiperspirants such as aluminum chloride as first-line treatment. No studies have previously been published evaluating the effect of antiperspirant on prosthetic users.

02

Conditions studied

  • Hyperhidrosis
  • Residual Limbs

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Keywords

  • Lower limb amputation
  • Hyperhidrosis
  • Prosthetic users
  • Aluminum chloride
  • Sweating
03

In context

Hyperhidrosis

111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.

This study's enrollment of 7 is below the median of 50 across 99 interventional studies indexed under Hyperhidrosis.

Browse Hyperhidrosis studies →

Lead sponsor

This is the only study on the registry with Sophies Minde Ortopedi as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Open wounds on the stump,
  2. Known sensitivity or allergy to iodine and/or starch,
  3. Known sensitivity to antiperspirant.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Effect of antiperspirant

    Aluminium chloride 15 percent

    Other: Topical antiperspirant

Interventions

  • OtherTopical antiperspirant

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Four weeks

  2. 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)

    Time frame: Four weeks

Secondary outcomes

  1. Numerical Ranking Scale (NRS 100)

    Numerical Ranking Scale (NRS 100) (with 0 as low and 100 as high) is used to investigate the following question: * How much sweating do you experience on the stump? * How much does sweating affect your function? * How much does sweating reduce your quality of life? * How much does sweating affect walking related to instability? * How much does sweating affect your activity level? * How much does sweating affect your skin quality on the stump

    Time frame: Four weeks

07

Study locations

1 site
  • Sophies Minde Ortopdi AS
    Oslo, 0667, Norway
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05501444
Lead sponsor
Sophies Minde Ortopedi
Responsible party
Sponsor
First posted
Aug 15, 2022
Start date
Aug 9, 2022
Primary completion
Dec 31, 2022
Completion
Mar 30, 2023
Last update
Apr 13, 2023

Study contacts

Jette Schack, PhD
principal investigator · Sophies Minde Ortopedi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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