Histological Analysis Following Ulthera System Treatment for Hyperhidrosis

Completed · Not applicable

Conditions studied: Hyperhidrosis

In brief

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.

Key facts

Study ID

NCT01708551

Run by

Ulthera, Inc

People needed

59

Starts

2012-08-01

Expected to finish

2015-08-01

Last updated by the study team

2017-12-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Center for Clinical and Cosmetic Research — Aventura, Florida, United States

Full record on ClinicalTrials.gov

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