Hyperhidrosis | Histological Analysis Following Ulthera System Treatment for Hyperhidrosis
Hyperhidrosis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - 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. - 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. Exclusion Criteria: - 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. - 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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Ulthera System TreatmentFocused ultrasound energy delivered below the surface of the skin
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Group ASubjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments; dual depth treatment at 4.5mm and 3.0mm.
Group BSubjects 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 CSubjects will receive one double-density Ulthera System treatment; dual depth treatment at 4.5mm and 3.0mm.
Group DSubjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments at 2.0mm treatment depth and standard energy level.
Group ESubjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments at 2.0mm treatment depth and adjusted energy level.
Start Date: August 2012
Completed Date: August 2015
Primary Outcome: Reduction in the number of sweat glands from baseline to 90-days post-treatment.
Secondary Outcome: Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment
Study sponsors, principal investigator, and references
Principal Investigator: Mark Nestor, MD, PhD
Lead Sponsor: Ulthera, Inc