HyperhidrosisNCT01713673
Feasibility Study: Safety and Efficacy of the Ulthera® System for 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
Up to 20 subjects will be treated. Subjects will receive two (2) bilateral Ultherapy™ or Sham treatments of the axilla. The study hypothesis is that subjects who receive Ultherapy™ treatment will have a greater reduction in axillary sweating compared to subjects receiving Sham treatments. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Apr 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 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 over a period of 5 minutes
- 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
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
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- Unwillingness to wash off deodorants and abstain use 72 hours prior to treatments or assessments
- History of previous Ultherapy™ treatment to the axilla
- 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
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: Feasibility Study: A Prospective, Parallel, Randomized, Sham-controlled, Blinded Pilot Trial of the Safety and Efficacy of the Ulthera® System for Treatment of Axillary Hyperhidrosis
Up to 20 subjects will be treated. Subjects will receive two (2) bilateral Ultherapy™ or Sham treatments of the axilla. The study hypothesis is that subjects who receive Ultherapy™ treatment will have a greater reduction in axillary sweating compared to subjects receiving Sham treatments. Follow-up visits will occur at 7 and 14 days following treatment #1, and at 7, 14, 30, 60 and 90 days following treatment #2. At each follow-up visit, assessments will be completed to compare the amount of axillary sweating compared to baseline.
Read the detailed description
This study is a prospective, single-center, randomized, sham-controlled, blinded pilot clinical trial. Subjects will be randomly assigned to one of two treatment groups in a 2:1 randomization scheme, two (2) subjects assigned to receive Ultherapy™ treatment to every one subject assigned to receive Sham treatment.
Gravimetric measurement of sweat production and starch iodine tests will be performed, and Hyperhidrosis Disease Severity Scale (HDSS) scores will be obtained, prior to treatment and at each follow-up visit. Patient satisfaction will also be assessed. Sham treated subjects will have the option of continuing to Stage II and receive active treatment after completion of their Stage I 90 day study visit.
In a protocol amendment, the initial Stage I study cohort, excluding Sham treated subjects who opt to continue to Stage II, will be recruited to complete one long-term follow-up visit at 365 days following subjects' second study treatment. The same follow-up assessments will be completed to compare the amount of axillary sweating compared to baseline.
- Conditions
- Hyperhidrosis
- Being tested
- Ulthera System Treatment, Sham 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 TreatmentDrug
Also called Ultherapy™
Focused ultrasound energy delivered below the surface of the skin
Sham treatmentDrug
Study treatment using the Ulthera System, but delivering no ultrasound energy.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Subjects receive Ulthera System Treatments according to the pre-defined Ulthera® System energy settings. Receives: Drug: Ulthera System Treatment |
| Sham Treatment | Sham comparator | Subjects will receive Sham treatments using the Ulthera® System with the energy set to 0.00 Joules. Receives: Drug: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with HDSS scores of 1 or 2
The HDSS scale is a qualitative measure of the severity of the condition based on how it affects subjects' daily activities. Subjects select the statement that best reflects their experience with underarm sweating on a 4 point scale, with 1 = sweating never noticeable and 4 = sweating is intolerable.
Measured: 30 days post-treatment #2
Secondary outcomes (2)
Reduction in spontaneous axillary sweat production
Assessed by a gravimetric method as measured by a 50% reduction or more compared to baseline.
Measured: Participants will be followed to 365 days post treatment #2
Subject Satisfaction
Subject satisfaction will be measured using a Patient Satisfaction Questionnaire (PSQ.)
Measured: Participants will be followed to 365 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 posted25 Oct 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionApr 2013
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 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
- NCT01713673
- Sponsor's protocol ID
- ULT-125
- Status last verified
- Jun 2013
- First submitted
- 22 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: A Prospective, Parallel, Randomized, Sham-controlled, Blinded Pilot Trial of the Safety and Efficacy of the Ulthera® System for Treatment of Axillary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT01713673
- Acronym / sponsor ID
- ULT-125
- Conditions
- Hyperhidrosis
- Keywords
- Hyperhidrosis, Axillary sweating, Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ulthera, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Apr 2013 (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.
Up to 20 subjects will be treated. Subjects will receive two (2) bilateral Ultherapy™ or Sham treatments of the axilla. The study hypothesis is that subjects who receive Ultherapy™ treatment will have a greater reduction in axillary sweating compared to subjects receiving Sham treatments. Follow-up visits will occur at 7 and 14 days following treatment #1, and at 7, 14, 30, 60 and 90 days following treatment #2. At each follow-up visit, assessments will be completed to compare the amount of axillary sweating compared to baseline.
Detailed description
This study is a prospective, single-center, randomized, sham-controlled, blinded pilot clinical trial. Subjects will be randomly assigned to one of two treatment groups in a 2:1 randomization scheme, two (2) subjects assigned to receive Ultherapy™ treatment to every one subject assigned to receive Sham treatment.
Gravimetric measurement of sweat production and starch iodine tests will be performed, and Hyperhidrosis Disease Severity Scale (HDSS) scores will be obtained, prior to treatment and at each follow-up visit. Patient satisfaction will also be assessed. Sham treated subjects will have the option of continuing to Stage II and receive active treatment after completion of their Stage I 90 day study visit.
In a protocol amendment, the initial Stage I study cohort, excluding Sham treated subjects who opt to continue to Stage II, will be recruited to complete one long-term follow-up visit at 365 days following subjects' second study treatment. The same follow-up assessments will be completed to compare the amount of axillary sweating compared to baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Drug: Ulthera System TreatmentSubjects receive Ulthera System Treatments according to the pre-defined Ulthera® System energy settings. |
| Sham Treatment | Sham comparator | Drug: Sham treatmentSubjects will receive Sham treatments using the Ulthera® System with the energy set to 0.00 Joules. |
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
- At least 50 mg of spontaneous resting axillary sweat production in each axilla measured gravimetrically at room temperature/humidity over a period of 5 minutes
- 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 (12 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: Ultherapy™Focused ultrasound energy delivered below the surface of the skin | Drug | Active Treatment |
| Sham treatmentStudy treatment using the Ulthera System, but delivering no ultrasound energy. | Drug | Sham Treatment |
Primary outcome
Percentage of subjects with HDSS scores of 1 or 2
Time frame: 30 days post-treatment #2
The HDSS scale is a qualitative measure of the severity of the condition based on how it affects subjects' daily activities. Subjects select the statement that best reflects their experience with underarm sweating on a 4 point scale, with 1 = sweating never noticeable and 4 = sweating is intolerable.
2 secondary outcomes
Reduction in spontaneous axillary sweat production
Time frame: Participants will be followed to 365 days post treatment #2
Subject Satisfaction
Time frame: Participants will be followed to 365 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 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, 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 12 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. 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 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?
Percentage of subjects with HDSS scores of 1 or 2 (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.