To evaluate the Ulthera System and the 7-3.0mm transducer for treating axillary hyperhidrosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Subjects will receive 2 treatments (day 1 and day 30), each at a 3.0mm depth and 0.30 Joule of energy. Treatment will be delivered in a 3\*4 grid, 12 treatment squares, delivering 60 lines of treatment per square, i.e., 720 lines per axilla in each treatment (1440 lines total per treatment.)
Rosenpark Research, Study Research Center; Merz Investigational Site #0490099
Darmstadt, Germany
Haut- & Laserzentrum, Merz Investigational Site #0490362
Potsdam, Germany
Number of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Reduction at Day 30 Post Second Treatment
Treatment success was defined as a reduction on the HDSS score from a value of 3 or 4 at baseline to a 1 or 2 at 30-day post second treatment. The HDSS was a validated scale used for primary axillary/underarm hyperhidrosis participants. HDSS provides a qualitative measure of the severity of participant's condition based on how it affects their daily activities. It is a 4-point scale (1-4) with scores as: 1 (underarm sweating was never noticeable and never interferes with daily activities); 2 (underarm sweating was tolerable but sometimes interferes with daily activities); 3 (underarm sweating was barely tolerable and frequently interferes with daily activities); and 4 (underarm sweating was intolerable and always interferes with daily activities).
Time frame: Day 60 (30 days post second treatment)
Number of Participants With HDSS Score Reduction at Day 90 Post Second Treatment
Treatment success was defined as an HDSS score reduction from a value of a 3 or 4 to a 1 or 2 at 90-day post second treatment. The HDSS was a validated scale used for primary axillary/underarm hyperhidrosis participants. HDSS provides a qualitative measure of the severity of participant's condition based on how it affects their daily activities. It is a 4-point scale (1-4) with scores as: 1 (underarm sweating was never noticeable and never interferes with daily activities); 2 (underarm sweating was tolerable but sometimes interferes with daily activities); 3 (underarm sweating was barely tolerable and frequently interferes with daily activities); and 4 (underarm sweating was intolerable and always interferes with daily activities).
Time frame: Day 120 (90 days post second treatment)
Number of Participants With Gravimetric Axillary Sweat Reduction by at Least 50 Percent (%) at Days 30 and 90 Post Second Treatment
Treatment success for gravimetric sweat production test was defined as a 50% or more reduction in spontaneous sweat production compared to baseline at 30 days and 90 days post second treatment. Gravimetric sweat production was measured using a pre-weighed filter paper placed into the axilla for a period of 5 minutes. The paper was removed and weighed and rate of sweat production was calculated in milligram per 5 minute (mg/5 min) based on the difference in end-weight and pre-weight.
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Time frame: Days 60 (30 days post second treatment) and 120 (90 days post second treatment)
Number of Participants Who Showed Improvement With the Starch Iodine Test at Days 30 and 90 Post Second Treatment
Improvement for the starch iodine test was defined as a reduction in the dark blue starch iodine area, both the left and right axilla needed to show improvement for a participant to be classified as improved. The starch iodine test was used to assess the area involved in excessive sweating by visually identifying areas that were actively producing sweat. The test was performed by applying iodine solution to the axilla and allowing the solution to dry. After drying, starch was sprinkled on the area. The light-brown iodine color turns dark purple as iodine-starch complexes form in the liquid medium with the sweat rising to the surface of the affected area. Starch iodine test was captured with digital images.
Time frame: Days 60 (30 days post second treatment) and 120 (90 days post second treatment)