Axillary HyperhidrosisULT-218NCT03320096
Evaluation of the Ulthera System for Treating Axillary Hyperhidrosis
A study testing Microfocused ultrasound with visualization in people with Axillary Hyperhidrosis, run by Ulthera, Inc at 2 sites in Germany.
Trial summary
To evaluate the Ulthera System and the 7-3.0mm transducer for treating axillary hyperhidrosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Axillary Hyperhidrosis
- What is being tested?
- Microfocused ultrasound with visualization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesGermany
- Study dates
- 13 Dec 2016to 22 Aug 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18-75 years.
- 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.
- 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 .
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.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Rosenpark Research, Study Research Center; Merz Investigational Site #0490099
Darmstadt, 64283
Haut- & Laserzentrum, Merz Investigational Site #0490362
Potsdam, 14467
About this study
To evaluate the Ulthera System and the 7-3.0mm transducer for treating axillary hyperhidrosis.
- Conditions
- Axillary Hyperhidrosis
- Being tested
- Microfocused ultrasound with visualization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microfocused ultrasound with visualizationDevice
Also called Ultherapy, Ulthera treatment
Subjects will receive 2 treatments (day 1 and day 30), each at a 3.0mm depth and 0.30 Joule of energy. Treatment will be delivered in a 3*4 grid, 12 treatment squares, delivering 60 lines of treatment per square, i.e., 720 lines per axilla in each treatment (1440 lines total per treatment.)
| Study group | Role | What they receive |
|---|---|---|
| Microfocused ultrasound with visualization | Experimental | Not described Receives: Device: Microfocused ultrasound with visualization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Reduction at Day 30 Post Second Treatment
Treatment success was defined as a reduction on the HDSS score from a value of 3 or 4 at baseline to a 1 or 2 at 30-day post second treatment. The HDSS was a validated scale used for primary axillary/underarm hyperhidrosis participants. HDSS provides a qualitative measure of the severity of participant's condition based on how it affects their daily activities. It is a 4-point scale (1-4) with scores as: 1 (underarm sweating was never noticeable and never interferes with daily activities); 2 (underarm sweating was tolerable but sometimes interferes with daily activities); 3 (underarm sweating was barely tolerable and frequently interferes with daily activities); and 4 (underarm sweating was intolerable and always interferes with daily activities).
Measured: Day 60 (30 days post second treatment)
Secondary outcomes (3)
Number of Participants With HDSS Score Reduction at Day 90 Post Second Treatment
Treatment success was defined as an HDSS score reduction from a value of a 3 or 4 to a 1 or 2 at 90-day post second treatment. The HDSS was a validated scale used for primary axillary/underarm hyperhidrosis participants. HDSS provides a qualitative measure of the severity of participant's condition based on how it affects their daily activities. It is a 4-point scale (1-4) with scores as: 1 (underarm sweating was never noticeable and never interferes with daily activities); 2 (underarm sweating was tolerable but sometimes interferes with daily activities); 3 (underarm sweating was barely tolerable and frequently interferes with daily activities); and 4 (underarm sweating was intolerable and always interferes with daily activities).
Measured: Day 120 (90 days post second treatment)
Number of Participants With Gravimetric Axillary Sweat Reduction by at Least 50 Percent (%) at Days 30 and 90 Post Second Treatment
Treatment success for gravimetric sweat production test was defined as a 50% or more reduction in spontaneous sweat production compared to baseline at 30 days and 90 days post second treatment. Gravimetric sweat production was measured using a pre-weighed filter paper placed into the axilla for a period of 5 minutes. The paper was removed and weighed and rate of sweat production was calculated in milligram per 5 minute (mg/5 min) based on the difference in end-weight and pre-weight.
Measured: Days 60 (30 days post second treatment) and 120 (90 days post second treatment)
Number of Participants Who Showed Improvement With the Starch Iodine Test at Days 30 and 90 Post Second Treatment
Improvement for the starch iodine test was defined as a reduction in the dark blue starch iodine area, both the left and right axilla needed to show improvement for a participant to be classified as improved. The starch iodine test was used to assess the area involved in excessive sweating by visually identifying areas that were actively producing sweat. The test was performed by applying iodine solution to the axilla and allowing the solution to dry. After drying, starch was sprinkled on the area. The light-brown iodine color turns dark purple as iodine-starch complexes form in the liquid medium with the sweat rising to the surface of the affected area. Starch iodine test was captured with digital images.
Measured: Days 60 (30 days post second treatment) and 120 (90 days post second treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start13 Dec 2016
- Primary completion19 Jun 2017
- Study completion22 Aug 2017
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.
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320096
- Sponsor's protocol ID
- M960001007
- Other IDs
- DRKS00011603
- Acronym
- ULT-218
- Status last verified
- Oct 2017
- First submitted
- 20 Oct 2017
- Last updated
- 10 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ulthera System for Treating Axillary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT03320096
- Acronym / sponsor ID
- ULT-218 / M960001007
- Conditions
- Axillary Hyperhidrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2016 (actual)
- Primary completion
- 19 Jun 2017 (actual)
- Study completion
- 22 Aug 2017 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Posted 10 Jul 2019
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 Ulthera System and the 7-3.0mm transducer for treating axillary hyperhidrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microfocused ultrasound with visualization | Experimental | Device: Microfocused ultrasound with visualization |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, age 18-75 years.
- 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.
- 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 .
Key exclusion criteria (6 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 |
|---|---|---|
| Microfocused ultrasound with visualizationAlso: Ultherapy, Ulthera treatmentSubjects will receive 2 treatments (day 1 and day 30), each at a 3.0mm depth and 0.30 Joule of energy. Treatment will be delivered in a 3*4 grid, 12 treatment squares, delivering 60 lines of treatment per square, i.e., 720 lines per axilla in each treatment (1440 lines total per treatment.) | Device | Microfocused ultrasound with visualization |
Primary outcome
Number of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Reduction at Day 30 Post Second Treatment
Time frame: Day 60 (30 days post second treatment)
Treatment success was defined as a reduction on the HDSS score from a value of 3 or 4 at baseline to a 1 or 2 at 30-day post second treatment. The HDSS was a validated scale used for primary axillary/underarm hyperhidrosis participants. HDSS provides a qualitative measure of the severity of participant's condition based on how it affects their daily activities. It is a 4-point scale (1-4) with scores as: 1 (underarm sweating was never noticeable and never interferes with daily activities); 2 (underarm sweating was tolerable but sometimes interferes with daily activities); 3 (underarm sweating was barely tolerable and frequently interferes with daily activities); and 4 (underarm sweating was intolerable and always interferes with daily activities).
3 secondary outcomes
Number of Participants With HDSS Score Reduction at Day 90 Post Second Treatment
Time frame: Day 120 (90 days post second treatment)
Number of Participants With Gravimetric Axillary Sweat Reduction by at Least 50 Percent (%) at Days 30 and 90 Post Second Treatment
Time frame: Days 60 (30 days post second treatment) and 120 (90 days post second treatment)
Number of Participants Who Showed Improvement With the Starch Iodine Test at Days 30 and 90 Post Second Treatment
Time frame: Days 60 (30 days post second treatment) and 120 (90 days post second treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Merz Medical Expert study director
Merz North America, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microfocused ultrasound with visualization in people with Axillary Hyperhidrosis, run by Ulthera, Inc at 2 sites in Germany.
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 6 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 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 10 Jul 2019). 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?
Number of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Reduction at Day 30 Post Second Treatment (time frame: Day 60 (30 days post second treatment)). 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 10 Jul 2019.