Primary Axillary HyperhidrosisNCT01722461
A Study of the Ulthera® System for the Treatment of Axillary Hyperhidrosis
A study testing Ulthera System in people with Primary Axillary Hyperhidrosis, run by Ulthera, Inc at 6 sites in United States.
Trial summary
This is a prospective, multi-center, randomized, double-blinded study. Subjects enrolled will be randomly assigned to receive either active treatments for axillary hyperhidrosis with the Ulthera System in both axillas, or sham treatments, also with the Ulthera System but with the energy settings on the device set to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Axillary Hyperhidrosis
- What is being tested?
- Ulthera System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2012to Nov 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female, age 18 years or older.
- Subject is in good health.
- Diagnosis of primary focal axillary hyperhidrosis evidenced by at least two of the standard criteria.
- At least 50mg at 5 min of spontaneous resting axillary sweat production in each axilla measured gravimetrically
- A HDSS score of 3 or 4
- Willingness to comply with study visits and requirements
- Female subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1
- Female subjects over 40 years of age must have had a mammogram in the last 2 years
Who cannot join
- Has a dermal disorder including infection at anticipated treatment sites in either axilla.
- Has had axillary injections of botulinum toxin in the last year.
- Has an expected use of botulinum toxin for the treatment of any other disease during the study period.
- Has a known allergy to starch powder, iodine, or lidocaine.
- Has secondary hyperhidrosis
- Has had previous surgical treatment of hyperhidrosis
Show all 19Show fewer
- Has had prior miraDry treatment for axillary hyperhidrosis.
- Has used prescription antiperspirants in the last 14 days or plans to use them during the study period.
- Inability to withhold use of non-study-supplied antiperspirants and deodorants
- Unwillingness to wash off study-supplied antiperspirants and abstain from use for 72 hours prior to treatments or assessments.
- History of previous Ultherapy™ treatment to the axilla.
- Has a history of a bleeding disorder
- Has used of cholinomimetics, anticholinergics, or any oral herbal medicine treatments for hyperhidrosis in the past 4 weeks.
- Is a prisoner or under incarceration.
- Is participating in another clinical trial involving the use of investigational devices or drugs (or has in the last 30 days.)
- Has a history of cancer (some exceptions), lymphectomy, or a planned lymphectomy.
- Has a pacemaker or other electronic implant.
- Requires supplemental oxygen.
- Has used antiplatelet agents / Anticoagulants (Coumadin, Pradaxa, Heparin, Plavix) in the past 6 weeks
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
The Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
Few Institute of Aesthetic Plastic Surgery
Chicago, Illinois, 60611
Day Dermatology & Aesthetics
New York, New York, 10021
Virginia Clinical Research
Norfolk, Virginia, 23507
Roseville Facial Plastic Surgery
Roseville, California, 95661
St Louis University Dermatology
St Louis, Missouri, 63104
About this study
Official title: A Prospective, Multi-Center, Parallel, Randomized, Double-Blinded Study of the Efficacy and Safety of the Ulthera® System for the Treatment of Primary Axillary Hyperhidrosis
This is a prospective, multi-center, randomized, double-blinded study. Subjects enrolled will be randomly assigned to receive either active treatments for axillary hyperhidrosis with the Ulthera System in both axillas, or sham treatments, also with the Ulthera System but with the energy settings on the device set to deliver no ultrasound energy. Subjects will be randomized in a 2:1 ratio, with 2 subjects randomized to active treatment for every one subject randomized to sham treatment. Subjects will receive 2 study treatments 30 days apart.
Subjects and study personnel conducting efficacy measures will be blinded to the assigned treatment groups. The study hypothesis is that subjects in the active treatment group will have a greater reduction in underarm sweating compared to those in the sham group as measured by a quality of life questionnaire.
All subjects will undergo follow-up assessments at 14 days and 30 days from the date of their first study treatment, and 14 days, 30 days, 3 months and 6 months from the date of their second study treatment. Subjects in the active treatment group will also undergo follow-up assessments at 9 months and 12 months from the date of their second study treatment.
- Conditions
- Primary Axillary Hyperhidrosis
- Being tested
- Ulthera System, Sham treatment
- Keywords
- Excessive underarm sweating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulthera SystemDevice
Also called Ultherapy™
Focused ultrasound energy delivered below the surface of the skin
Sham treatmentDevice
Ulthera System delivering no ultrasound energy
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | Ulthera System treatment Receives: Device: Ulthera System |
| Sham treatment | Sham comparator | Ulthera System delivering no ultrasound energy Receives: Device: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating
As measured by the Hyperhidrosis Disease Severity Scale (HDSS), a quality of life questionnaire
Measured: 30 days post-treatment #2
Secondary outcomes (4)
Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating
As measured by the HDSS
Measured: 6 month post treatment #2
Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating
As measured by the HDSS
Measured: 12 months post treatment #2
Percentage of active treated subjects compared to sham treated subjects with reduced average spontaneous axillary sweat production
As measured by gravimetric method
Measured: 3 months post treatment
Percentage of active treated subjects compared to sham treated subjects with reduced spontaneous axillary sweat production
As measured by gravimetric method
Measured: Subjects will be followed to 12 months 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 posted6 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionNov 2013
Why it stopped: Sponsor decision; unexpectedly high sham response at primary outcome time point.
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulthera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark S Nestor, M.D., Ph.D, Principal investigator, The Center for Clinical and Cosmetic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722461
- Sponsor's protocol ID
- ULT-119
- Status last verified
- Dec 2013
- First submitted
- 2 Nov 2012
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
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
- A Prospective, Multi-Center, Parallel, Randomized, Double-Blinded Study of the Efficacy and Safety of the Ulthera® System for the Treatment of Primary Axillary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT01722461
- Acronym / sponsor ID
- ULT-119
- Conditions
- Primary Axillary Hyperhidrosis
- Keywords
- Excessive underarm sweating
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision; unexpectedly high sham response at primary outcome time point.
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 6 Nov 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.
This is a prospective, multi-center, randomized, double-blinded study. Subjects enrolled will be randomly assigned to receive either active treatments for axillary hyperhidrosis with the Ulthera System in both axillas, or sham treatments, also with the Ulthera System but with the energy settings on the device set to deliver no ultrasound energy. Subjects will be randomized in a 2:1 ratio, with 2 subjects randomized to active treatment for every one subject randomized to sham treatment. Subjects will receive 2 study treatments 30 days apart.
Subjects and study personnel conducting efficacy measures will be blinded to the assigned treatment groups. The study hypothesis is that subjects in the active treatment group will have a greater reduction in underarm sweating compared to those in the sham group as measured by a quality of life questionnaire.
All subjects will undergo follow-up assessments at 14 days and 30 days from the date of their first study treatment, and 14 days, 30 days, 3 months and 6 months from the date of their second study treatment. Subjects in the active treatment group will also undergo follow-up assessments at 9 months and 12 months from the date of their second study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Device: Ulthera SystemUlthera System treatment |
| Sham treatment | Sham comparator | Device: Sham treatmentUlthera System delivering no ultrasound energy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female, age 18 years or older.
- Subject is in good health.
- Diagnosis of primary focal axillary hyperhidrosis evidenced by at least two of the standard criteria.
- At least 50mg at 5 min of spontaneous resting axillary sweat production in each axilla measured gravimetrically
- A HDSS score of 3 or 4
Key exclusion criteria (19 listed)
- Has a dermal disorder including infection at anticipated treatment sites in either axilla.
- Has had axillary injections of botulinum toxin in the last year.
- Has an expected use of botulinum toxin for the treatment of any other disease during the study period.
- Has a known allergy to starch powder, iodine, or lidocaine.
- Has secondary hyperhidrosis
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 SystemAlso: Ultherapy™Focused ultrasound energy delivered below the surface of the skin | Device | Active treatment |
| Sham treatmentUlthera System delivering no ultrasound energy | Device | Sham treatment |
Primary outcome
Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating
Time frame: 30 days post-treatment #2
As measured by the Hyperhidrosis Disease Severity Scale (HDSS), a quality of life questionnaire
4 secondary outcomes
Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating
Time frame: 6 month post treatment #2
Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating
Time frame: 12 months post treatment #2
Percentage of active treated subjects compared to sham treated subjects with reduced average spontaneous axillary sweat production
Time frame: 3 months post treatment
Percentage of active treated subjects compared to sham treated subjects with reduced spontaneous axillary sweat production
Time frame: Subjects will be followed to 12 months post treatment #2
Results and safety
The study was stopped early (reason given: Sponsor decision; unexpectedly high sham response at primary outcome time point.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
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 S Nestor, M.D., Ph.D principal investigator
The Center for Clinical and Cosmetic Research
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulthera System in people with Primary Axillary Hyperhidrosis, run by Ulthera, Inc at 6 sites 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 8 inclusion and 19 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: stopped early, 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 6 sites 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Sponsor decision; unexpectedly high sham response at primary outcome time point.). Results are not available in the source record.
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 of active treated subjects compared to sham treated subjects with reduced underarm sweating (time frame: 30 days 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 24 Nov 2017.