HyperhidrosisNCT01708551
Histological Analysis Following Ulthera System Treatment for Hyperhidrosis
A study testing Ulthera System Treatment in people with Hyperhidrosis, run by Ulthera, Inc at 1 site in United States.
Trial summary
Up to 60 subjects will be enrolled into one of five treatment groups. Subjects enrolled in Groups A, B or C will undergo axillary punch biopsies during the course of the trial to determine the number and depth of the sweat glands, and receive dual depth treatments (4.5mm and 3.0mm); either two bilateral Ultherapy™… 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
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2015
- 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
- Groups A, C, D and E: 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.) Group B: A mean of >50mg/5min of sweat production following a prior Ultherapy treatment.
- A HDSS score is 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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- Absence of physical conditions unacceptable to the investigator.
- Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
- Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control.
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
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
About this study
Official title: Histological Analysis and Correlation With Ultrasound Imaging to Evaluate the Safety and Effectiveness of Treating Axillary Hyperhidrosis Subjects With the Ulthera® System
Up to 60 subjects will be enrolled into one of five treatment groups. Subjects enrolled in Groups A, B or C will undergo axillary punch biopsies during the course of the trial to determine the number and depth of the sweat glands, and receive dual depth treatments (4.5mm and 3.0mm); either two bilateral Ultherapy™ treatments to the axillas 30 days apart (Groups A and B) or one bilateral Ultherapy™ treatment (Group C). Subjects in Groups D and E will receive two bilateral Ultherapy™ treatments to the axillas 30 days apart at a 2.0mm treatment depth and two different energy settings (Group D at 0.45 J, Group E at 0.30 J). Protocol amended (Sept 2014): Subjects in Groups D and E will receive treatments at the same energy setting (0.30J) and two treatment densities: Group D, 60 lines/treatment square; Group E, 40 lines per treatment square. Follow-up visits will occur at 7, 30, 90 and 180 days post-treatment #2.
Read the detailed description
This study is a prospective, single-center, non-randomized pilot clinical trial. Subjects enrolled will include:
- those naïve to Ultherapy™ for treatment of hyperhidrosis (Group A, n=31); dual-depth treatment at 4.5mm and 3.0mm;
- those who were non-responders to a prior Ultherapy™ treatment for hyperhidrosis (Group B, n=approx 5), dual-depth treatment at 4.5mm and 3.0mm;
- those naïve to Ultherapy™ for treatment of hyperhidrosis who will receive one double-density study treatment (Group C, n=4), dual-depth treatment at 4.5mm and 3.0mm;
- those naïve to Ultherapy™ for treatment of hyperhidrosis (Group D, n=10), single-depth treatment at 2.0mm at standard energy;
- those naïve to Ultherapy™ for treatment of hyperhidrosis (Group E, n=10), single-depth treatment at 2.0mm at adjusted energy.
- Protocol amended (Sept 2014): Subjects in Groups D and E will receive treatments at the same energy setting (0.30J) and two treatment densities: Group D, 60 lines/treatment square; Group E, 40 lines per treatment square.
Ultrasound images will be captured of each axilla to assess dermal thickness and depth of sweat glands. A gravimetric measurement of sweat production and starch iodine test will be performed prior to treatment. Digital images of the starch iodine test will be obtained. Hyperhidrosis Disease Severity Scale (HDSS)scores will be obtained prior to each treatment. During treatment, the average Numeric Rating Scale (NRS) score will be obtained by axilla treated. Efficacy will be determined by a reduction in the number of sweat glands from baseline to 90-days post-treatment, as evidenced by histological analysis. Subject Gravimetric results, Starch iodine results, and HDSS scores at all follow-ups compared to baseline will also be analyzed as secondary outcomes.
- Conditions
- Hyperhidrosis
- Being tested
- Ulthera System Treatment
- Keywords
- Hyperhidrosis, Axillary sweating, Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc.
- 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 Ultherapy™
Focused ultrasound energy delivered below the surface of the skin
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Subjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments; dual depth treatment at 4.5mm and 3.0mm. Receives: Device: Ulthera System Treatment |
| Group B | Active comparator | Subjects who were non-responders to a prior Ultherapy™ treatment for hyperhidrosis will receive bilateral Ulthera System treatments; dual depth treatment at 4.5mm and 3.0mm. Receives: Device: Ulthera System Treatment |
| Group C | Active comparator | Subjects will receive one double-density Ulthera System treatment; dual depth treatment at 4.5mm and 3.0mm. Receives: Device: Ulthera System Treatment |
| Group D | Active comparator | Subjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments at 2.0mm treatment depth and standard energy level. Receives: Device: Ulthera System Treatment |
| Group E | Active comparator | Subjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments at 2.0mm treatment depth and adjusted energy level. Receives: Device: Ulthera System Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the number of sweat glands from baseline to 90-days post-treatment.
Based on histological analyses of biopsied, Ultherapy™-treated, tissue, the changed in the number of sweat glands present at 90days post-treatment will be compared to the number of sweat glands present at baseline.
Measured: 90 days post-treatment
Secondary outcomes (6)
Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment
A 50% reduction or more in Gravimetric measure at 7 days post-treatment compared to baseline.
Measured: 7 days post-treatment
Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment
A 50% reduction or more in Gravimetric measure at 30 days post-treatment compared to baseline.
Measured: 30 days post-treatment
Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment
A 50% reduction or more in Gravimetric measure at 90 days post-treatment compared to baseline.
Measured: 90 days post-treatment
Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment
A 50% reduction or more in Gravimetric measure at 180 days post-treatment compared to baseline.
Measured: 180 days post-treatment
HDSS score reduction
HDSS score reduction from a 3 or 4 to a 1 or 2
Measured: 90 days post-treatment
Starch iodine test
Assess the reduction in starch iodine test area at 90 days post-treatment compared to baseline.
Measured: 90 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2015
- Study completionAug 2015
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Nestor, MD, PhD, Principal investigator, The Center for Clinical and Cosmetic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708551
- Sponsor's protocol ID
- ULT-134
- Status last verified
- Oct 2015
- First submitted
- 15 Oct 2012
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- 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
- Histological Analysis and Correlation With Ultrasound Imaging to Evaluate the Safety and Effectiveness of Treating Axillary Hyperhidrosis Subjects With the Ulthera® System
- ClinicalTrials.gov ID
- NCT01708551
- Acronym / sponsor ID
- ULT-134
- Conditions
- Hyperhidrosis
- Keywords
- Hyperhidrosis, Axillary sweating, Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 17 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.
Up to 60 subjects will be enrolled into one of five treatment groups. Subjects enrolled in Groups A, B or C will undergo axillary punch biopsies during the course of the trial to determine the number and depth of the sweat glands, and receive dual depth treatments (4.5mm and 3.0mm); either two bilateral Ultherapy™ treatments to the axillas 30 days apart (Groups A and B) or one bilateral Ultherapy™ treatment (Group C). Subjects in Groups D and E will receive two bilateral Ultherapy™ treatments to the axillas 30 days apart at a 2.0mm treatment depth and two different energy settings (Group D at 0.45 J, Group E at 0.30 J). Protocol amended (Sept 2014): Subjects in Groups D and E will receive treatments at the same energy setting (0.30J) and two treatment densities: Group D, 60 lines/treatment square; Group E, 40 lines per treatment square. Follow-up visits will occur at 7, 30, 90 and 180 days post-treatment #2.
Detailed description
This study is a prospective, single-center, non-randomized pilot clinical trial. Subjects enrolled will include:
- those naïve to Ultherapy™ for treatment of hyperhidrosis (Group A, n=31); dual-depth treatment at 4.5mm and 3.0mm;
- those who were non-responders to a prior Ultherapy™ treatment for hyperhidrosis (Group B, n=approx 5), dual-depth treatment at 4.5mm and 3.0mm;
- those naïve to Ultherapy™ for treatment of hyperhidrosis who will receive one double-density study treatment (Group C, n=4), dual-depth treatment at 4.5mm and 3.0mm;
- those naïve to Ultherapy™ for treatment of hyperhidrosis (Group D, n=10), single-depth treatment at 2.0mm at standard energy;
- those naïve to Ultherapy™ for treatment of hyperhidrosis (Group E, n=10), single-depth treatment at 2.0mm at adjusted energy.
- Protocol amended (Sept 2014): Subjects in Groups D and E will receive treatments at the same energy setting (0.30J) and two treatment densities: Group D, 60 lines/treatment square; Group E, 40 lines per treatment square.
Ultrasound images will be captured of each axilla to assess dermal thickness and depth of sweat glands. A gravimetric measurement of sweat production and starch iodine test will be performed prior to treatment. Digital images of the starch iodine test will be obtained. Hyperhidrosis Disease Severity Scale (HDSS)scores will be obtained prior to each treatment. During treatment, the average Numeric Rating Scale (NRS) score will be obtained by axilla treated. Efficacy will be determined by a reduction in the number of sweat glands from baseline to 90-days post-treatment, as evidenced by histological analysis. Subject Gravimetric results, Starch iodine results, and HDSS scores at all follow-ups compared to baseline will also be analyzed as secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Ulthera System TreatmentSubjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments; dual depth treatment at 4.5mm and 3.0mm. |
| Group B | Active comparator | Device: Ulthera System TreatmentSubjects who were non-responders to a prior Ultherapy™ treatment for hyperhidrosis will receive bilateral Ulthera System treatments; dual depth treatment at 4.5mm and 3.0mm. |
| Group C | Active comparator | Device: Ulthera System TreatmentSubjects will receive one double-density Ulthera System treatment; dual depth treatment at 4.5mm and 3.0mm. |
| Group D | Active comparator | Device: Ulthera System TreatmentSubjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments at 2.0mm treatment depth and standard energy level. |
| Group E | Active comparator | Device: Ulthera System TreatmentSubjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments at 2.0mm treatment depth and adjusted energy level. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female, ages 18-75
- Subject is in good health
- Diagnosis of bilateral axillary hyperhidrosis refractory to previous topical therapies
- Groups A, C, D and E: 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.) Group B: A mean of >50mg/5min of sweat production following a prior Ultherapy treatment.
- A HDSS score is 3 or 4. An attempt will be made to approximate an equal number of scores 3 and 4.
Key exclusion criteria (13 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: Ultherapy™Focused ultrasound energy delivered below the surface of the skin | Device | Group A, Group B, Group C, Group D, Group E |
Primary outcome
Reduction in the number of sweat glands from baseline to 90-days post-treatment.
Time frame: 90 days post-treatment
Based on histological analyses of biopsied, Ultherapy™-treated, tissue, the changed in the number of sweat glands present at 90days post-treatment will be compared to the number of sweat glands present at baseline.
6 secondary outcomes
Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment
Time frame: 7 days post-treatment
Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment
Time frame: 30 days post-treatment
Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment
Time frame: 90 days post-treatment
Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment
Time frame: 180 days post-treatment
HDSS score reduction
Time frame: 90 days post-treatment
Starch iodine test
Time frame: 90 days post-treatment
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.
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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, PhD principal investigator
The Center for Clinical and 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 9 inclusion and 13 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?
Reduction in the number of sweat glands from baseline to 90-days post-treatment. (time frame: 90 days post-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 14 Dec 2017.