Evaluation of the Ulthera System for Treating Axillary Hyperhidrosis (ULT-218)

Ulthera

Status

Completed

Conditions

Axillary Hyperhidrosis

Treatments

Device: Microfocused ultrasound with visualization

Study type

Interventional

Funder types

Industry

Identifiers

DRKS00011603 (Registry Identifier)

M960001007

Details and patient eligibility

About

To evaluate the Ulthera System and the 7-3.0mm transducer for treating axillary hyperhidrosis.

Enrollment

20 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 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.