Clinical trial NCT03320096: Evaluation of the Ulthera System for Treating Axillary Hyperhidrosis
Official title: Evaluation of the Ulthera System for Treating Axillary Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Axillary Hyperhidrosis
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Reduction at Day 30 Post Second Treatment
timeFrame: Day 60 (30 days post second treatment)
Secondary outcomes:
measure: Number of Participants With HDSS Score Reduction at Day 90 Post Second Treatment
timeFrame: Day 120 (90 days post second treatment)
measure: Number of Participants With Gravimetric Axillary Sweat Reduction by at Least 50 Percent (%) at Days 30 and 90 Post Second Treatment
timeFrame: Days 60 (30 days post second treatment) and 120 (90 days post second treatment)
measure: Number of Participants Who Showed Improvement With the Starch Iodine Test at Days 30 and 90 Post Second Treatment
timeFrame: Days 60 (30 days post second treatment) and 120 (90 days post second treatment)
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Rosenpark Research, Study Research Center; Merz Investigational Site #0490099
city: Potsdam
country: Germany
facility: Haut- & Laserzentrum, Merz Investigational Site #0490362
Study officials:
affiliation: Merz North America, Inc.
name: Merz Medical Expert
role: STUDY_DIRECTOR
References: