Feasibility Study: Ulthera® System for the Treatment of Axillary Hyperhidrosis
Completed · Not applicable · Has a placebo group
Conditions studied: Hyperhidrosis
In brief
Single-center, randomized, split-body, pilot study, treatment of up to 23 subjects in two treatment groups. Subjects will receive two Ultherapy treatments at Day 0 with follow-ups at 7 and 14 days post-treatment #1, and Day 28 with follow-ups are 7, 14, 30, 60, 90 days post-treatment #2.
Key facts
- Study ID
- NCT01713959
- Run by
- Ulthera, Inc
- People needed
- 15
- Starts
- 2011-08-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2017-11-24
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
- 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.)
- HDSS score of 3 or 4.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
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 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.
- Women who are pregnant, lactating, possibly pregnant or planning a pregnancy during the study period.
Where it is running
- The Center for Clinical & Cosmetic Research — Aventura, Florida, United States
Full record on ClinicalTrials.gov
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