Axillary HyperhidrosisNCT01274611
Botox and Suction-Curettage for Treatment of Excessive Underarm Sweating (Axillary Hyperhidrosis)
A study testing Botulinum Toxin Type A and Suction-Curettage in people with Axillary Hyperhidrosis, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of two methods in the treatment of excessive underarm sweating (axillary hyperhidrosis): suction-curettage and Botox injections. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Axillary Hyperhidrosis
- What is being tested?
- Botulinum Toxin Type A and Suction-Curettage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2011
- Phase
- Interventional
- 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
Who may be able to join
- Ages 18 to 65
- BMI 18.5 - 29.99
- Diagnosis of bilateral axillary hyperhidrosis refractory to previous topical therapies
- Subject is in good health
- Subject has the willingness and ability to understand and provide informed consent
Who cannot join
- Under age 18 or over age 65
- Pregnancy or lactating
- BMI ≥ 30 or ≤18.4
- Subjects who have undergone axillary suction/curettage any time in the past
- Subjects who have undergone axillary BT-A injections in the past year
- Subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months
Show all 9Show fewer
- Subjects with a history of a bleeding disorder
- Subjects with an open, non-healing sore or infection near site of procedure
- Subjects with allergies to iodine, starch powder, albumin, or any botulinum toxin product
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: Comparing the Efficacy Between Suction-Curettage and Botox Injections in the Treatment of Axillary Hyperhidrosis
The purpose of this study is to compare the effectiveness of two methods in the treatment of excessive underarm sweating (axillary hyperhidrosis): suction-curettage and Botox injections. Suction-curettage is a method in which the doctor will insert a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located. This method has been shown in some studies to effectively reduce underarm sweating for months at a time. Botox is a Food and Drug Administration (FDA) approved drug that in small doses, paralyses muscles. It is most commonly and famously used in the treatment of facial wrinkles. However, it has also been approved to treat excessive sweating. When injected in areas that sweat excessively, sweating can be significantly reduced in that area for months at a time. This study is a pilot study designed to determine feasibility of these procedures.
- Conditions
- Axillary Hyperhidrosis
- Being tested
- Botulinum Toxin Type A, Suction-Curettage
- Keywords
- sweating, sweat, underarm, axillary, hyperhidrosis, botox, liposuction, suction-curettage, suction, curettage
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called botox
Botox will be injected into the underarm, targeting the sweat glands, to stop underarm sweating.
Suction-CurettageDevice
Also called liposuction
The doctor will insert a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating.
| Study group | Role | What they receive |
|---|---|---|
| Suction-Curettage | Active comparator | Not described Receives: Device: Suction-Curettage |
| Botox | Experimental | Not described Receives: Drug: Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months
The primary outcome measure was the treatment associated unilateral axillary percentage change of sweat rate in milligrams per minute in the exercise-induced state measured at baseline compared with the sweat rate measured 3 months after treatment.
This process entails placing filter paper on the area of concern for a specific amount of time, after which the paper is weighed and sweat production is quantified in units of weight per time. The amount of sweat produced was recorded in milligrams per minute by subtracting the initial weight of the paper segment before exercise from the final, post-application weight, after exercise and dividing by 5 minutes.
Percentage sweat rate was calculated as [(sweat rate at baseline - sweat rate at 3 months)/sweat rate at baseline]*100 with a positive percent change indicating sweat rate reduction if the baseline had a higher sweat rate.
Measured: baseline and 3 months
Secondary outcomes (1)
The Change in Hyperhidrosis Disease Severity Scores From Baseline Compared to 3 Months After Treatment
Change in mean score on the Hyperhidrosis Disease Severity Scale (HDSS) from baseline minus 3 months after treatment.
The HDSS iquestionnaire assigns a point value to the patient's view:
My sweating is...
- never noticeable and never interferes with my daily activities
- tolerable but sometimes interferes with my daily activities
- barely tolerable and frequently interferes with my daily activities
- intolerable and always interferes with my daily activities
Lower point values are considered better and higher point values are considered worse.
A larger change in score between baseline and 3 months is considered a better outcome and a smaller change in score is considered a worse outcome for each treatment. Change scores were calculated (baseline minus 3 months). Positive change scores indicate that scores were better; negative change scores indicate their scores were worse after treatment.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2011
- Study completionDec 2011
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 Axillary HyperhidrosisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Alejandra Onate, M.S., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274611
- Sponsor's protocol ID
- STU40780
- Status last verified
- Dec 2021
- First submitted
- 10 Jan 2011
- Last updated
- 6 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy Between Suction-Curettage and Botox Injections in the Treatment of Axillary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT01274611
- Acronym / sponsor ID
- STU40780
- Conditions
- Axillary Hyperhidrosis
- Keywords
- sweating, sweat, underarm, axillary, hyperhidrosis, botox, liposuction, suction-curettage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Jan 2011 (estimated)
- Results
- Posted 3 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness of two methods in the treatment of excessive underarm sweating (axillary hyperhidrosis): suction-curettage and Botox injections. Suction-curettage is a method in which the doctor will insert a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located. This method has been shown in some studies to effectively reduce underarm sweating for months at a time. Botox is a Food and Drug Administration (FDA) approved drug that in small doses, paralyses muscles. It is most commonly and famously used in the treatment of facial wrinkles. However, it has also been approved to treat excessive sweating. When injected in areas that sweat excessively, sweating can be significantly reduced in that area for months at a time. This study is a pilot study designed to determine feasibility of these procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suction-Curettage | Active comparator | Device: Suction-Curettage |
| Botox | Experimental | Drug: Botulinum Toxin Type A |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 18 to 65
- BMI 18.5 - 29.99
- Diagnosis of bilateral axillary hyperhidrosis refractory to previous topical therapies
- Subject is in good health
- Subject has the willingness and ability to understand and provide informed consent
Key exclusion criteria (9 listed)
- Under age 18 or over age 65
- Pregnancy or lactating
- BMI ≥ 30 or ≤18.4
- Subjects who have undergone axillary suction/curettage any time in the past
- Subjects who have undergone axillary BT-A injections in the past year
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 |
|---|---|---|
| Botulinum Toxin Type AAlso: botoxBotox will be injected into the underarm, targeting the sweat glands, to stop underarm sweating. | Drug | Botox |
| Suction-CurettageAlso: liposuctionThe doctor will insert a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating. | Device | Suction-Curettage |
Primary outcome
Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months
Time frame: baseline and 3 months
The primary outcome measure was the treatment associated unilateral axillary percentage change of sweat rate in milligrams per minute in the exercise-induced state measured at baseline compared with the sweat rate measured 3 months after treatment. This process entails placing filter paper on the area of concern for a specific amount of time, after which the paper is weighed and sweat production is quantified in units of weight per time. The amount of sweat produced was recorded in milligrams per minute by subtracting the initial weight of the paper segment before exercise from the final, post-application weight, after exercise and dividing by 5 minutes. Percentage sweat rate was calculated as [(sweat rate at baseline - sweat rate at 3 months)/sweat rate at baseline]*100 with a positive percent change indicating sweat rate reduction if the baseline had a higher sweat rate.
1 secondary outcome
The Change in Hyperhidrosis Disease Severity Scores From Baseline Compared to 3 Months After Treatment
Time frame: Baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Alejandra Onate, M.S. principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin Type A and Suction-Curettage in people with Axillary Hyperhidrosis, run by Northwestern University 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 5 inclusion and 9 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 6 Dec 2021. 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 3 Feb 2014). 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?
Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months (time frame: baseline and 3 months). 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 6 Dec 2021.