Primary Axillary HyperhidrosisNCT02286765
Ulthera® System for Treating Axillary Hyperhidrosis
A study testing Ulthera System treatment in people with Primary Axillary Hyperhidrosis, run by Ulthera, Inc at 1 site in United States.
Trial summary
Up to 20 enrolled subjects will be treated. Subjects will receive two Ulthera® treatments on the axillas provided 30 days apart. Follow-up visits will occur at 7, 30, 90 and 180 days following the last treatment. Protocol amendment: The study was expanded to enroll an additional 20 subjects into Group A. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Axillary Hyperhidrosis
- What is being tested?
- Ulthera System treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Sep 2016
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, age 18-75 years.
- Subject in good health.
- Diagnosis of bilateral axillary hyperhidrosis refractory to previous topical therapies.
- At least 50 mg of spontaneous resting axillary sweat production in each axilla measured gravimetrically at room temperature/humidity (20 - 25.6°C/20-80%) over a period of 5 minutes. (Patients should be at rest for at least 30 minutes after physical exercise including walking.)
- HDSS score of 3 or 4. An attempt will be made to approximate an equal number of scores 3 and 4.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
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- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
- Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
- Postmenopausal for at least 12 months prior to study;
- Without a uterus and/or both ovaries; or
- Bilateral tubal ligation at least six months prior to study enrollment.
- Absence of physical or psychological conditions unacceptable to the investigator.
- Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other NSAID, and Vitamin E in the 2 weeks prior to each study treatment .
- Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
Who cannot join
- Dermal disorder including infection at anticipated treatment sites in either axilla.
- Previous botulinum toxin treatment of the axilla in the past year.
- Expected use of botulinum toxin for the treatment of any other disease during the study period.
- Known allergy to starch powder, iodine, lidocaine, or epinephrine.
- Secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma and malaria.
- Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery.
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- Unwillingness to wash off deodorants and abstain use 72 hours prior to treatments or assessments.
- Subjects with a history of a bleeding disorder
- Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas.)
- Use of cholinomimetics, anticholinergics, or any oral herbal medicine treatments for hyperhidrosis.
- Inability to withhold use of antiperspirants and deodorants, or any other topical treatments for hyperhidrosis within 72 hours prior to study treatments and assessments.
- Unwillingness for complete shaving or removal of underarm hair within 12 hours prior to study treatments and follow-up visits.
- Women who are pregnant, lactating, possibly pregnant or planning a pregnancy during the study period.
- Inability to understand the protocol or to give informed consent.
- History of chronic drug or alcohol abuse.
- History of autoimmune disease.
- Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
- Subjects who anticipate the need for surgery or overnight hospitalization during the study.
- Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
- Concurrent enrollment in any study involving the use of investigational devices or drugs.
- Use of antiplatelet agents / Anticoagulants (Coumadin, Heparin, Plavix) in the past 6 weeks;
- Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Louis University Dermatology
St Louis, Missouri, 63104
About this study
Official title: Optimization of the Ulthera® System for Treating Axillary Hyperhidrosis
Up to 20 enrolled subjects will be treated. Subjects will receive two Ulthera® treatments on the axillas provided 30 days apart. Follow-up visits will occur at 7, 30, 90 and 180 days following the last treatment.
Protocol amendment: The study was expanded to enroll an additional 20 subjects into Group A.
Read the detailed description
This study is a prospective, single-center, randomized clinical trial. Up to 20 subjects who are naïve to Ultherapy for treatment of hyperhidrosis will be enrolled and treated at a 2.0mm depth at two different treatment densities (Group A and Group B).
Group A will include up to 10 treated subjects. Subjects receiving treatment in a 3 x 4 grid, 12 treatment squares, 60 lines of treatment per square, at one treatment depth (2.0mm), at 0.30 J of energy.
Group B will include up to 10 treated subjects. Subjects receiving treatment in a 3 x 4 grid, 12 treatment squares, 40 lines of treatment per square, at one treatment depth (2.0mm), at 0.30 J of energy.
Gravimetric sweat production measures and starch iodine tests will be completed at baseline, treatment visit #2, and at all follow-ups for all study groups. Digital images of the starch iodine test will be obtained. Hyperhidrosis Disease Severity Scale (HDSS) scores will be obtained at baseline, each treatment visit, and at all follow-ups for all study groups.
- Conditions
- Primary Axillary Hyperhidrosis
- Being tested
- Ulthera System treatment
- Keywords
- Ulthera System, Ultherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulthera System treatmentDevice
Also called Ultherapy
Micro-focused ultrasound energy delivered below the surface of the skin
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Subjects receiving Ulthera System treatment in a 3 x 4 grid, 12 treatment squares, 60 lines of treatment per square, at one treatment depth (2.0mm), at 0.30 J of energy Receives: Device: Ulthera System treatment |
| Group B | Active comparator | Subjects receiving Ulthera System treatment in a 3 x 4 grid, 12 treatment squares, 40 lines of treatment per square, at one treatment depth (2.0mm), at 0.30 J of energy Receives: Device: Ulthera System treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDSS score reduction
HDSS score reduction from a 3 or 4 at baseline to a 1 or 2 at 30 days post-treatment #2.
Measured: Day 30 post-treatment #2
Secondary outcomes (8)
Sweat production by gravimetric measure
Reduction in spontaneous axillary sweat production assessed by a gravimetric method, as measured by a 50% reduction or more compared to baseline.
- Gravimetric method is performed by drying the surface of the skin, then applying a pre-weighed filter paper to the axilla for a period of time measured by a stopwatch. The paper is then weighed and the rate of sweat production is calculated in mg/min.
Measured: 7 Days post-treatment #2
Sweat production by gravimetric measure
Reduction in spontaneous axillary sweat production assessed by a gravimetric method, as measured by a 50% reduction or more compared to baseline.
- Gravimetric method is performed by drying the surface of the skin, then applying a pre-weighed filter paper to the axilla for a period of time measured by a stopwatch. The paper is then weighed and the rate of sweat production is calculated in mg/min.
Measured: 90 Days post-treatment #2
Sweat production by gravimetric measure
Reduction in spontaneous axillary sweat production assessed by a gravimetric method, as measured by a 50% reduction or more compared to baseline.
- Gravimetric method is performed by drying the surface of the skin, then applying a pre-weighed filter paper to the axilla for a period of time measured by a stopwatch. The paper is then weighed and the rate of sweat production is calculated in mg/min.
Measured: 30 Days post-treatment #2
Sweat production by gravimetric measure
Reduction in spontaneous axillary sweat production assessed by a gravimetric method, as measured by a 50% reduction or more compared to baseline.
- Gravimetric method is performed by drying the surface of the skin, then applying a pre-weighed filter paper to the axilla for a period of time measured by a stopwatch. The paper is then weighed and the rate of sweat production is calculated in mg/min.
Measured: 180 Days post-treatment #2
HDSS score reduction
HDSS score reduction from a 3 or 4 to a 1 or 2 at 90 days post treatment #2.
Measured: 90 Days post-treatment #2
Starch iodine test
Starch iodine test to assess area of efficacy with digital images.
- Starch Iodine test is performed by applying an iodine solution to the sweaty area. After it dries, starch is sprinkled on the area. The starch-iodine combination turns a dark blue color wherever excess sweat is present. Digital images of the starch iodine test will be obtained.
Measured: 7 Days post-treatment #2
Starch iodine test
Starch iodine test to assess area of efficacy with digital images.
- Starch Iodine test is performed by applying an iodine solution to the sweaty area. After it dries, starch is sprinkled on the area. The starch-iodine combination turns a dark blue color wherever excess sweat is present. Digital images of the starch iodine test will be obtained.
Measured: 30 Days post-treatment #2
Starch iodine test
Starch iodine test to assess area of efficacy with digital images.
- Starch Iodine test is performed by applying an iodine solution to the sweaty area. After it dries, starch is sprinkled on the area. The starch-iodine combination turns a dark blue color wherever excess sweat is present. Digital images of the starch iodine test will be obtained.
Measured: 90 Days post-treatment #2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Axillary 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kari Larson, MBA, Study director, Ulthera, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286765
- Sponsor's protocol ID
- ULT-126
- Status last verified
- Jun 2017
- First submitted
- 5 Nov 2014
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of the Ulthera® System for Treating Axillary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT02286765
- Acronym / sponsor ID
- ULT-126
- Conditions
- Primary Axillary Hyperhidrosis
- Keywords
- Ulthera System, Ultherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 Nov 2014 (estimated)
- 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.
Up to 20 enrolled subjects will be treated. Subjects will receive two Ulthera® treatments on the axillas provided 30 days apart. Follow-up visits will occur at 7, 30, 90 and 180 days following the last treatment.
Protocol amendment: The study was expanded to enroll an additional 20 subjects into Group A.
Detailed description
This study is a prospective, single-center, randomized clinical trial. Up to 20 subjects who are naïve to Ultherapy for treatment of hyperhidrosis will be enrolled and treated at a 2.0mm depth at two different treatment densities (Group A and Group B).
Group A will include up to 10 treated subjects. Subjects receiving treatment in a 3 x 4 grid, 12 treatment squares, 60 lines of treatment per square, at one treatment depth (2.0mm), at 0.30 J of energy.
Group B will include up to 10 treated subjects. Subjects receiving treatment in a 3 x 4 grid, 12 treatment squares, 40 lines of treatment per square, at one treatment depth (2.0mm), at 0.30 J of energy.
Gravimetric sweat production measures and starch iodine tests will be completed at baseline, treatment visit #2, and at all follow-ups for all study groups. Digital images of the starch iodine test will be obtained. Hyperhidrosis Disease Severity Scale (HDSS) scores will be obtained at baseline, each treatment visit, and at all follow-ups for all study groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Ulthera System treatmentSubjects receiving Ulthera System treatment in a 3 x 4 grid, 12 treatment squares, 60 lines of treatment per square, at one treatment depth (2.0mm), at 0.30 J of energy |
| Group B | Active comparator | Device: Ulthera System treatmentSubjects receiving Ulthera System treatment in a 3 x 4 grid, 12 treatment squares, 40 lines of treatment per square, at one treatment depth (2.0mm), at 0.30 J of energy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female, age 18-75 years.
- Subject in good health.
- Diagnosis of bilateral axillary hyperhidrosis refractory to previous topical therapies.
- At least 50 mg of spontaneous resting axillary sweat production in each axilla measured gravimetrically at room temperature/humidity (20 - 25.6°C/20-80%) over a period of 5 minutes. (Patients should be at rest for at least 30 minutes after physical exercise including walking.)
- HDSS score of 3 or 4. An attempt will be made to approximate an equal number of scores 3 and 4.
Key exclusion criteria (22 listed)
- Dermal disorder including infection at anticipated treatment sites in either axilla.
- Previous botulinum toxin treatment of the axilla in the past year.
- Expected use of botulinum toxin for the treatment of any other disease during the study period.
- Known allergy to starch powder, iodine, lidocaine, or epinephrine.
- Secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma and malaria.
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 |
|---|---|---|
| Ulthera System treatmentAlso: UltherapyMicro-focused ultrasound energy delivered below the surface of the skin | Device | Group A, Group B |
Primary outcome
HDSS score reduction
Time frame: Day 30 post-treatment #2
HDSS score reduction from a 3 or 4 at baseline to a 1 or 2 at 30 days post-treatment #2.
8 secondary outcomes
Sweat production by gravimetric measure
Time frame: 7 Days post-treatment #2
Sweat production by gravimetric measure
Time frame: 90 Days post-treatment #2
Sweat production by gravimetric measure
Time frame: 30 Days post-treatment #2
Sweat production by gravimetric measure
Time frame: 180 Days post-treatment #2
HDSS score reduction
Time frame: 90 Days post-treatment #2
Starch iodine test
Time frame: 7 Days post-treatment #2
Starch iodine test
Time frame: 30 Days post-treatment #2
Starch iodine test
Time frame: 90 Days post-treatment #2
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 14 Dec 2017.
- Individual participant dataSharing planned: No
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.
Kari Larson, MBA study director
Ulthera, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulthera System treatment in people with Primary Axillary Hyperhidrosis, run by Ulthera, Inc 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 14 inclusion and 22 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 14 Dec 2017. 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?
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?
HDSS score reduction (time frame: Day 30 post-treatment #2). 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 14 Dec 2017.