An interventional study of Ulthera System and Sham treatment in Primary Axillary Hyperhidrosis, sponsored by Ulthera, Inc. Terminated at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-24.
Sponsored by Ulthera, Inc · Not applicable, Interventional, and Treatment
This is a prospective, multi-center, randomized, double-blinded study. Subjects enrolled will be randomly assigned to receive either active treatments for axillary hyperhidrosis with the Ulthera System in both axillas, or sham treatments, also with the Ulthera System but with the energy settings on the device set to deliver no ultrasound energy. Subjects will be randomized in a 2:1 ratio, with 2 subjects randomized to active treatment for every one subject randomized to sham treatment. Subjects will receive 2 study treatments 30 days apart.
Subjects and study personnel conducting efficacy measures will be blinded to the assigned treatment groups. The study hypothesis is that subjects in the active treatment group will have a greater reduction in underarm sweating compared to those in the sham group as measured by a quality of life questionnaire.
All subjects will undergo follow-up assessments at 14 days and 30 days from the date of their first study treatment, and 14 days, 30 days, 3 months and 6 months from the date of their second study treatment. Subjects in the active treatment group will also undergo follow-up assessments at 9 months and 12 months from the date of their second study treatment.
109 studies on the registry are indexed under Hyperhidrosis; 9 are open to participants now.
This study's enrollment of 120 is above the median of 53 across 98 interventional studies indexed under Hyperhidrosis.
Browse Hyperhidrosis studies →Ulthera, Inc is the lead sponsor of 46 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ulthera System treatment
Device: Ulthera System
Ulthera System delivering no ultrasound energy
Device: Sham treatment
Focused ultrasound energy delivered below the surface of the skin
Also known as: Ultherapy™
Ulthera System delivering no ultrasound energy
Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating
As measured by the Hyperhidrosis Disease Severity Scale (HDSS), a quality of life questionnaire
Time frame: 30 days post-treatment #2
Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating
As measured by the HDSS
Time frame: 6 month post treatment #2
Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating
As measured by the HDSS
Time frame: 12 months post treatment #2
Percentage of active treated subjects compared to sham treated subjects with reduced average spontaneous axillary sweat production
As measured by gravimetric method
Time frame: 3 months post treatment
Percentage of active treated subjects compared to sham treated subjects with reduced spontaneous axillary sweat production
As measured by gravimetric method
Time frame: Subjects will be followed to 12 months post treatment #2
This study is terminated, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Ulthera, Inc