HyperhidrosisNCT05501444
Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users
A study testing Topical antiperspirant in people with Hyperhidrosis and Residual Limbs, run by Sophies Minde Ortopedi at 1 site in Norway.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperhidrosis, Residual Limbs
- What is being tested?
- Topical antiperspirant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteNorway
- Study dates
- 9 Aug 2022to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Open wounds on the stump,
- Known sensitivity or allergy to iodine and/or starch,
- Known sensitivity to antiperspirant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users: a Pilot Study
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.
- Conditions
- Hyperhidrosis, Residual Limbs
- Being tested
- Topical antiperspirant
- Keywords
- Lower limb amputation, Hyperhidrosis, Prosthetic users, Aluminum chloride, Sweating
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical antiperspirantOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Effect of antiperspirant | Experimental | Aluminium chloride 15 percent Receives: Other: Topical antiperspirant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start9 Aug 2022
- Primary completion31 Dec 2022
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperhidrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The project is carried out as a pilot study
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sophies Minde Ortopedi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jette Schack, PhD, Principal investigator, Sophies Minde Ortopedi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501444
- Sponsor's protocol ID
- FoU_2022_Hyperhidrosis
- Status last verified
- Apr 2023
- First submitted
- 11 Aug 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users: a Pilot Study
- ClinicalTrials.gov ID
- NCT05501444
- Acronym / sponsor ID
- FoU_2022_Hyperhidrosis
- Conditions
- Hyperhidrosis, Residual Limbs
- Keywords
- Lower limb amputation, Hyperhidrosis, Prosthetic users, Aluminum chloride, Sweating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Sophies Minde OrtopediIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The project is carried out as a pilot study
| Arm | Type | Receives |
|---|---|---|
| Effect of antiperspirant | Experimental | Other: Topical antiperspirantAluminium chloride 15 percent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Open wounds on the stump,
- Known sensitivity or allergy to iodine and/or starch,
- Known sensitivity to antiperspirant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical antiperspirantThe 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. | Other | Effect of antiperspirant |
Primary outcome
Hyperhidrosis Disease Severity Scale (HDSS)
Time frame: Four weeks
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.
Sweating Intensity Visual Scale (SIVS)
Time frame: Four weeks
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)
1 secondary outcome
Numerical Ranking Scale (NRS 100)
Time frame: Four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jette Schack, PhD principal investigator
Sophies Minde Ortopedi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical antiperspirant in people with Hyperhidrosis and Residual Limbs, run by Sophies Minde Ortopedi at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperhidrosis Disease Severity Scale (HDSS) (time frame: Four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.