Histological Analysis Following Ulthera System Treatment for Hyperhidrosis (NCT01708551) | Clinical Trial Compass
CompletedNot Applicable
Histological Analysis Following Ulthera System Treatment for Hyperhidrosis
United States59 participantsStarted 2012-08
Plain-language 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 Ultherapyâ„¢ treatments to the axillas 30 days apart (Groups A and B) or one bilateral Ultherapyâ„¢ treatment (Group C). Subjects in Groups D and E will receive two bilateral Ultherapyâ„¢ 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 can participate
Age range18 Years – 75 Years
SexALL
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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 pow…
What they're measuring
1
Reduction in the number of sweat glands from baseline to 90-days post-treatment.