HyperhidrosisNCT01713959
Feasibility Study: Ulthera® System for the Treatment of Axillary Hyperhidrosis
A study testing Ulthera System treatment in people with Hyperhidrosis, run by Ulthera, Inc at 1 site in United States.
Trial summary
Single-center, randomized, split-body, pilot study, treatment of up to 23 subjects in two treatment groups. Subjects will receive two Ultherapy treatments at Day 0 with follow-ups at 7 and 14 days post-treatment #1, and Day 28 with follow-ups are 7, 14, 30, 60, 90 days post-treatment #2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperhidrosis
- What is being tested?
- Ulthera System treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jun 2012
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female, ages 18-75
- Subject is 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.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
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 or iodine.
- 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.
- Women who are pregnant, lactating, possibly pregnant or planning a pregnancy during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Clinical & Cosmetic Research
Aventura, Florida, 33180
About this study
Official title: Feasibility Study: Evaluation of the Safety and Efficacy of the Ulthera® System for the Treatment of Axillary Hyperhidrosis
Single-center, randomized, split-body, pilot study, treatment of up to 23 subjects in two treatment groups. Subjects will receive two Ultherapy treatments at Day 0 with follow-ups at 7 and 14 days post-treatment #1, and Day 28 with follow-ups are 7, 14, 30, 60, 90 days post-treatment #2.
Read the detailed description
Subjects will be randomized to one of two study groups:
- Group A: Split body treatment. Ultherapy to one axilla, Sham treatment to the other axilla.
- Group B: Bilateral Ultherapy treatments, with a pre-treatment subcutaneous lidocaine injection administered to one axillary side.
Hyperhidrosis Disease Severity Scale (HDSS), gravimetric test and starch iodine test will be obtained at all study visits. Patient satisfaction questionnaires will also be obtained at 30, 60 and 90 days post-treatment #2.
- Conditions
- Hyperhidrosis
- Being tested
- Ulthera System treatment, Sham treatment
- Keywords
- Underarm sweating
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulthera System treatmentDevice
Also called Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
Ulthera System: Focused ultrasound energy delivered below the surface of the skin.
Sham treatmentDevice
Sham Treatment: Use of the Ulthera System with the system adjusted to deliver 0 energy.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Split Body Treatment | Experimental | Active treatment of one axilla with the Ulthera System Treatment; Sham treatment of one axilla. Receives: Device: Ulthera System treatment; Device: Sham treatment |
| Group B: Ulthera System Treatment w lido | Active comparator | Subjects receive a bilateral Ulthera System Treatment, with one axilla receiving a subcutaneous lidocaine injection. Receives: Device: Ulthera System treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in sweat production
Axillary hyperhidrosis as assessed by using a gravimetric method.
Measured: 90-days post-treatment treatment #2
Secondary outcomes (3)
Improvement in sweat production at follow-up timepoints other than 90 days post-treatment
Axillary hyperhidrosis as assessed by using a gravimetric method.
Measured: Participants will be followed up to 60 days post-treatment
Area of efficacy
Starch iodine test will be used to assess the area of efficacy. Imaging will be obtained.
Measured: Participants will be followed for up to 90 days following treatment #2.
Qualitative measure of hyperhidrosis severity
The HDSS is a scale used for primary axillary/underarm hyperhidrosis patients. It provides a qualitative measure of the severity of their condition based on how it affects their daily activities. Patients select the statement that best reflects their experience with underarm sweating.
Measured: Participants will be followed for up to 90 days following treatment #2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startAug 2011
- Primary completionApr 2012
- Study completionJun 2012
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Nestor, MD, Ph.D, Principal investigator, The Center for Clinical & Cosmetic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713959
- Sponsor's protocol ID
- ULT-121
- Status last verified
- Jun 2013
- First submitted
- 15 Oct 2012
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study: Evaluation of the Safety and Efficacy of the Ulthera® System for the Treatment of Axillary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT01713959
- Acronym / sponsor ID
- ULT-121
- Conditions
- Hyperhidrosis
- Keywords
- Underarm sweating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Oct 2012 (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.
Single-center, randomized, split-body, pilot study, treatment of up to 23 subjects in two treatment groups. Subjects will receive two Ultherapy treatments at Day 0 with follow-ups at 7 and 14 days post-treatment #1, and Day 28 with follow-ups are 7, 14, 30, 60, 90 days post-treatment #2.
Detailed description
Subjects will be randomized to one of two study groups:
- Group A: Split body treatment. Ultherapy to one axilla, Sham treatment to the other axilla.
- Group B: Bilateral Ultherapy treatments, with a pre-treatment subcutaneous lidocaine injection administered to one axillary side.
Hyperhidrosis Disease Severity Scale (HDSS), gravimetric test and starch iodine test will be obtained at all study visits. Patient satisfaction questionnaires will also be obtained at 30, 60 and 90 days post-treatment #2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Split Body Treatment | Experimental | Device: Ulthera System treatment, Device: Sham treatmentActive treatment of one axilla with the Ulthera System Treatment; Sham treatment of one axilla. |
| Group B: Ulthera System Treatment w lido | Active comparator | Device: Ulthera System treatmentSubjects receive a bilateral Ulthera System Treatment, with one axilla receiving a subcutaneous lidocaine injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female, ages 18-75
- Subject is 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.
Key exclusion criteria (7 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 or iodine.
- 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: Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tighteningUlthera System: Focused ultrasound energy delivered below the surface of the skin. | Device | Group A - Split Body Treatment, Group B: Ulthera System Treatment w lido |
| Sham treatmentSham Treatment: Use of the Ulthera System with the system adjusted to deliver 0 energy. | Device | Group A - Split Body Treatment |
Primary outcome
Improvement in sweat production
Time frame: 90-days post-treatment treatment #2
Axillary hyperhidrosis as assessed by using a gravimetric method.
3 secondary outcomes
Improvement in sweat production at follow-up timepoints other than 90 days post-treatment
Time frame: Participants will be followed up to 60 days post-treatment
Area of efficacy
Time frame: Participants will be followed for up to 90 days following treatment #2.
Qualitative measure of hyperhidrosis severity
Time frame: Participants will be followed for up to 90 days following 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 24 Nov 2017.
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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.
Mark Nestor, MD, Ph.D principal investigator
The Center for Clinical & Cosmetic Research
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 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 6 inclusion and 7 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 24 Nov 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?
Improvement in sweat production (time frame: 90-days post-treatment 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 24 Nov 2017.