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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01713959
Other study ID # ULT-121
Secondary ID
Status Completed
Phase N/A
First received October 15, 2012
Last updated November 21, 2017
Start date August 2011
Est. completion date June 2012

Study information

Verified date June 2013
Source Merz Pharmaceuticals, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Subjects will be randomized to one of two study groups:

- Group A: Split body treatment. Ultherapy to one axilla, Sham treatment to the other axilla.

- Group B: Bilateral Ultherapy treatments, with a pre-treatment subcutaneous lidocaine injection administered to one axillary side.

Hyperhidrosis Disease Severity Scale (HDSS), gravimetric test and starch iodine test will be obtained at all study visits. Patient satisfaction questionnaires will also be obtained at 30, 60 and 90 days post-treatment #2.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date June 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- 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.

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 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ulthera System treatment
Ulthera System: Focused ultrasound energy delivered below the surface of the skin.
Sham treatment
Sham Treatment: Use of the Ulthera System with the system adjusted to deliver 0 energy.

Locations

Country Name City State
United States The Center for Clinical & Cosmetic Research Aventura Florida

Sponsors (1)

Lead Sponsor Collaborator
Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in sweat production Axillary hyperhidrosis as assessed by using a gravimetric method. 90-days post-treatment treatment #2
Secondary Improvement in sweat production at follow-up timepoints other than 90 days post-treatment Axillary hyperhidrosis as assessed by using a gravimetric method. Participants will be followed up to 60 days post-treatment
Secondary Area of efficacy Starch iodine test will be used to assess the area of efficacy. Imaging will be obtained. Participants will be followed for up to 90 days following treatment #2.
Secondary Qualitative measure of hyperhidrosis severity The HDSS is a scale used for primary axillary/underarm hyperhidrosis patients. It provides a qualitative measure of the severity of their condition based on how it affects their daily activities. Patients select the statement that best reflects their experience with underarm sweating. Participants will be followed for up to 90 days following treatment #2
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