HyperhidrosisNCT02552199

A Non-Interventional Study To Assess Sweating

An observational study of Hyperhidrosis, run by Botanix Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To evaluate the gravimetric sweat measurements in subjects who meet the subjective criteria for a diagnosis of palmar hyperhidrosis compared to subjects without hyperhidrosis. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Hyperhidrosis
What is being tested?: gravimetric
How many people: 28 participants
Where: 1 siteUnited States
Study dates: Sep 2015to Oct 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Subjects with palmar hyperhidrosis and healthy subjects

Who may be able to join

Females should not be pregnant or lactating.
For subjects with palmar hyperhidrosis: Primary palmar hyperhidrosis of at least 6 months's duration and Hyperhidrosis disease severity score of 3 or 4 at baseline
For healthy participants: no history or current report of hyperhidrosis and Hyperhidrosis disease severity score of 1 at baseline

Who cannot join

Recent therapeutic interventions or treatments for palmar hyperhidrosis
Any major illness within 30 days before the screening
Females who are pregnant, lactating, or planning a pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

Carpinteria Dermatology
Carpinteria, California, 93013

Other trials in United States

About this study

Official title: A Non-Interventional Study To Assess Sweating, As Measured By Gravimetry, In Subjects With Primary Hyperhidrosis And In Healthy Individuals

To evaluate the gravimetric sweat measurements in subjects who meet the subjective criteria for a diagnosis of palmar hyperhidrosis compared to subjects without hyperhidrosis.

Read the detailed description

This is a Non-Interventional Study To Assess Sweating, As Measured By Gravimetry, In Subjects With Primary Hyperhidrosis And In Healthy Individuals .

The objective of this study is to determine the threshold gravimetric measurement for subjects with palmar hyperhidrosis.

Conditions: Hyperhidrosis
Being tested: gravimetric
Medical subject headings: Hyperhidrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

gravimetricOther

Study groups in NCT02552199
Study group	Role	What they receive
with hyperhidrosis		Patients with primary palmar hyperhidrosis Receives: Other: gravimetric
healthy		Healthy adult patients Receives: Other: gravimetric

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison of Mean Average (Standard Deviation) Total Palmar Gravimetric Sweat Production (GMSP) Between Subject Groups (Adult Patients With Hyperhidrosis Versus Healthy Adult Volunteers).
Gravimetric assessments were conducted in a temperature controlled room on two separate occasions over a five minute period (two assessments/palm), assessing both palms. An individual palm GMSP was determined by subtracting the Weight (g) of individual gauze in contact with palm after five minutes - Weight (g) of individual gauze prior to palmar contact. For this analysis, each participant could provide two results (1 Total GMSP/occasion) as:
Total GMSP 1 [g] = Right palm GMSP 1 [g] + Left palm GMSP 1 [g] Total GMSP 2 [g] = Right palm GMSP 2 [g] + Left Palm GMSP 2 [g] Mean average [g] (standard deviation) Total GMSPs were compared between Subject Groups (adult patients with hyperhidrosis versus healthy adult volunteers).
Measured: Gravimetric assessments were conducted in a temperature controlled room on two separate occasions over a five minute period (two assessments/palm), assessing both palms.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Oct 2015

First posted17 Sep 2015 (estimated)
Study startSep 2015
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02552199
Sponsor's protocol ID: BBI-4000-EM-101
Status last verified: Feb 2024
First submitted: 15 Sep 2015
Last updated: 15 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hyperhidrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Non-Interventional Study To Assess Sweating, As Measured By Gravimetry, In Subjects With Primary Hyperhidrosis And In Healthy Individuals
ClinicalTrials.gov ID: NCT02552199
Acronym / sponsor ID: BBI-4000-EM-101
Conditions: Hyperhidrosis
Study type: Observational
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Botanix PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 17 Sep 2015 (estimated)
Results: Posted 23 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the gravimetric sweat measurements in subjects who meet the subjective criteria for a diagnosis of palmar hyperhidrosis compared to subjects without hyperhidrosis.

Detailed description

This is a Non-Interventional Study To Assess Sweating, As Measured By Gravimetry, In Subjects With Primary Hyperhidrosis And In Healthy Individuals .

The objective of this study is to determine the threshold gravimetric measurement for subjects with palmar hyperhidrosis.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
with hyperhidrosis	–	Other: gravimetricPatients with primary palmar hyperhidrosis
healthy	–	Other: gravimetricHealthy adult patients

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Subjects with palmar hyperhidrosis and healthy subjects

Key inclusion criteria (3 listed)

Females should not be pregnant or lactating.
For subjects with palmar hyperhidrosis: Primary palmar hyperhidrosis of at least 6 months's duration and Hyperhidrosis disease severity score of 3 or 4 at baseline
For healthy participants: no history or current report of hyperhidrosis and Hyperhidrosis disease severity score of 1 at baseline

Key exclusion criteria (3 listed)

Recent therapeutic interventions or treatments for palmar hyperhidrosis
Any major illness within 30 days before the screening
Females who are pregnant, lactating, or planning a pregnancy

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
gravimetric	Other	healthy, with hyperhidrosis

Primary outcome

Comparison of Mean Average (Standard Deviation) Total Palmar Gravimetric Sweat Production (GMSP) Between Subject Groups (Adult Patients With Hyperhidrosis Versus Healthy Adult Volunteers).
Time frame: Gravimetric assessments were conducted in a temperature controlled room on two separate occasions over a five minute period (two assessments/palm), assessing both palms.
Gravimetric assessments were conducted in a temperature controlled room on two separate occasions over a five minute period (two assessments/palm), assessing both palms. An individual palm GMSP was determined by subtracting the Weight (g) of individual gauze in contact with palm after five minutes - Weight (g) of individual gauze prior to palmar contact. For this analysis, each participant could provide two results (1 Total GMSP/occasion) as: Total GMSP 1 [g] = Right palm GMSP 1 [g] + Left palm GMSP 1 [g] Total GMSP 2 [g] = Right palm GMSP 2 [g] + Left Palm GMSP 2 [g] Mean average [g] (standard deviation) Total GMSPs were compared between Subject Groups (adult patients with hyperhidrosis versus healthy adult volunteers).

Results and safety

Results posted to the registry on 23 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
With Hyperhidrosis	17	17
Healthy	11	11

Primary outcome: Comparison of Mean Average (Standard Deviation) Total Palmar Gravimetric Sweat Production (GMSP) Between Subject Groups (Adult Patients With Hyperhidrosis Versus Healthy Adult Volunteers).

Time frame: Gravimetric assessments were conducted in a temperature controlled room on two separate occasions over a five minute period (two assessments/palm), assessing both palms.. Mean (Standard Deviation). Unit: grams

Measure	With Hyperhidrosis n = 17	Healthy n = 11
Value	0.7687 (0.8300)	0.1762 (0.1010)

Population analysed: Full analysis set including all enrolled subjects.

Adverse events

Time frame: 14 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
With Hyperhidrosis	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Healthy	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hyperhidrosis

RecruitingObservational study
Targeting Nociceptors in Hidradenitis Suppurativa
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Recruiting
Botulinum Toxin Type A for Frontal Hyperhidrosis
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Not yet recruitingObservational study
"Incidence of Compensatory Hyperhidrosis After T3 Vs T3-4 Sympathectomy"
Compensatory Hyperhidrosis, Compensatory Sweating
Recruiting
A Polymer Film Device to Treat Excessive Palmar Sweating
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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.

Patricia S Walker, M.D.,Ph.D. study director

Botanix Pharmaceuticals

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hyperhidrosis, run by Botanix Pharmaceuticals at 1 site in United States.

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 3 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 15 Feb 2024. 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 United States. 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?

Yes. Results are posted in the registry (first posted 23 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Comparison of Mean Average (Standard Deviation) Total Palmar Gravimetric Sweat Production (GMSP) Between Subject Groups (Adult Patients With Hyperhidrosis Versus Healthy Adult Volunteers). (time frame: Gravimetric assessments were conducted in a temperature controlled room on two separate occasions over a five minute period (two assessments/palm), assessing both palms.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02552199.

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 15 Feb 2024.