Status:
COMPLETED
Evaluation of the Ulthera System for Treating Axillary Hyperhidrosis
Lead Sponsor:
Ulthera, Inc
Conditions:
Axillary Hyperhidrosis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
To evaluate the Ulthera System and the 7-3.0mm transducer for treating axillary hyperhidrosis.
Eligibility Criteria
Inclusion
- Male or female, age 18-75 years.
- 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. An attempt will be made to approximate an equal number of scores 3 and 4.
- Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other NSAID, and Vitamin E in the 2 weeks prior to each study treatment .
Exclusion
- 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.
Key Trial Info
Start Date :
December 13 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03320096
Start Date
December 13 2016
End Date
August 22 2017
Last Update
July 10 2019
Active Locations (2)
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1
Rosenpark Research, Study Research Center; Merz Investigational Site #0490099
Darmstadt, Germany, 64283
2
Haut- & Laserzentrum, Merz Investigational Site #0490362
Potsdam, Germany, 14467