Trial Outcomes & Findings for Evaluation of the Ulthera System for Treating Axillary Hyperhidrosis (NCT NCT03320096)
NCT ID: NCT03320096
Last Updated: 2019-07-10
Results Overview
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).
COMPLETED
NA
20 participants
Day 60 (30 days post second treatment)
2019-07-10
Participant Flow
The study was conducted at 2 sites in Germany.
A total of 20 participants were screened, enrolled and treated in the study.
Participant milestones
| Measure |
Ultherapy Treatment
Participants received two dual-depth Ultherapy treatment to each axilla at a treatment depth of 3.0 millimeter (mm) using 7-megahertz (MHz) transducer with 0.30 joules (J) of energy on Days 0 (Treatment 1) and 30 (Treatment 2). Participants were administered treatment in 3 inch\*4 inch grid, in at least 12 treatment squares. At each treatment visit, participants received a minimum of 720 treatment lines to each axilla (minimum of 1440 total lines of treatment for both axillae), delivering 60 treatment lines per treatment square.
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|---|---|
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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20
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Ulthera System for Treating Axillary Hyperhidrosis
Baseline characteristics by cohort
| Measure |
Ultherapy Treatment
n=20 Participants
Participants received two dual-depth Ultherapy treatment to each axilla at a treatment depth of 3.0 mm using 7-MHz transducer with 0.30 J of energy on Days 0 (Treatment 1) and 30 (Treatment 2). Participants were administered treatment in 3 inch\*4 inch grid, in at least 12 treatment squares. At each treatment visit, participants received a minimum of 720 treatment lines to each axilla (minimum of 1440 total lines of treatment for both axillae), delivering 60 treatment lines per treatment square.
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|---|---|
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Age, Continuous
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40.3 years
STANDARD_DEVIATION 10.9 • n=5 Participants
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Sex: Female, Male
Female
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16 Participants
n=5 Participants
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Sex: Female, Male
Male
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4 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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20 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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20 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
Germany
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20 participants
n=5 Participants
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Body Mass Index (BMI)
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24.1 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.0 • n=5 Participants
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Fitzpatrick Skin Type
Skin Type I
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0 Participants
n=5 Participants
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Fitzpatrick Skin Type
Skin Type II
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15 Participants
n=5 Participants
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Fitzpatrick Skin Type
Skin Type III
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4 Participants
n=5 Participants
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Fitzpatrick Skin Type
Skin Type IV
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1 Participants
n=5 Participants
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Fitzpatrick Skin Type
Skin Type V
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0 Participants
n=5 Participants
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Fitzpatrick Skin Type
Skin Type VI
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Day 60 (30 days post second treatment)Population: All evaluable treated participants in FAS who received a complete or partial study treatment and completed a follow-up visit at Day 30 post second treatment. The FAS was the subset of participants in SES for whom primary efficacy variable was available. The SES was the subset of all participants who were exposed to study treatment at least once.
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).
Outcome measures
| Measure |
Ultherapy Treatment
n=20 Participants
Participants received two dual-depth Ultherapy treatment to each axilla at a treatment depth of 3.0 mm using 7-MHz transducer with 0.30 J of energy on Days 0 (Treatment 1) and 30 (Treatment 2). Participants were administered treatment in 3 inch\*4 inch grid, in at least 12 treatment squares. At each treatment visit, participants received a minimum of 720 treatment lines to each axilla (minimum of 1440 total lines of treatment for both axillae), delivering 60 treatment lines per treatment square.
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|---|---|
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Number of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Reduction at Day 30 Post Second Treatment
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11 participants
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SECONDARY outcome
Timeframe: Day 120 (90 days post second treatment)Population: The FAS was the subset of participants in the SES for whom the primary efficacy variable was available (that is, all participants who had baseline and at least one post-baseline value of the primary efficacy variable). The SES was the subset of all participants who were exposed to study treatment at least once.
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).
Outcome measures
| Measure |
Ultherapy Treatment
n=20 Participants
Participants received two dual-depth Ultherapy treatment to each axilla at a treatment depth of 3.0 mm using 7-MHz transducer with 0.30 J of energy on Days 0 (Treatment 1) and 30 (Treatment 2). Participants were administered treatment in 3 inch\*4 inch grid, in at least 12 treatment squares. At each treatment visit, participants received a minimum of 720 treatment lines to each axilla (minimum of 1440 total lines of treatment for both axillae), delivering 60 treatment lines per treatment square.
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|---|---|
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Number of Participants With HDSS Score Reduction at Day 90 Post Second Treatment
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15 participants
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SECONDARY outcome
Timeframe: Days 60 (30 days post second treatment) and 120 (90 days post second treatment)Population: The FAS was the subset of participants in the SES for whom the primary efficacy variable was available (that is, all participants who had baseline and at least one post-baseline value of the primary efficacy variable). The SES was the subset of all participants who were exposed to study treatment at least once.
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.
Outcome measures
| Measure |
Ultherapy Treatment
n=20 Participants
Participants received two dual-depth Ultherapy treatment to each axilla at a treatment depth of 3.0 mm using 7-MHz transducer with 0.30 J of energy on Days 0 (Treatment 1) and 30 (Treatment 2). Participants were administered treatment in 3 inch\*4 inch grid, in at least 12 treatment squares. At each treatment visit, participants received a minimum of 720 treatment lines to each axilla (minimum of 1440 total lines of treatment for both axillae), delivering 60 treatment lines per treatment square.
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Number of Participants With Gravimetric Axillary Sweat Reduction by at Least 50 Percent (%) at Days 30 and 90 Post Second Treatment
Day 60
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12 participants
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Number of Participants With Gravimetric Axillary Sweat Reduction by at Least 50 Percent (%) at Days 30 and 90 Post Second Treatment
Day 120
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15 participants
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SECONDARY outcome
Timeframe: Days 60 (30 days post second treatment) and 120 (90 days post second treatment)Population: The FAS was the subset of participants in the SES for whom the primary efficacy variable was available (that is, all participants who had baseline and at least one post-baseline value of the primary efficacy variable). The SES was the subset of all participants who were exposed to study treatment at least once.
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.
Outcome measures
| Measure |
Ultherapy Treatment
n=20 Participants
Participants received two dual-depth Ultherapy treatment to each axilla at a treatment depth of 3.0 mm using 7-MHz transducer with 0.30 J of energy on Days 0 (Treatment 1) and 30 (Treatment 2). Participants were administered treatment in 3 inch\*4 inch grid, in at least 12 treatment squares. At each treatment visit, participants received a minimum of 720 treatment lines to each axilla (minimum of 1440 total lines of treatment for both axillae), delivering 60 treatment lines per treatment square.
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|---|---|
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Number of Participants Who Showed Improvement With the Starch Iodine Test at Days 30 and 90 Post Second Treatment
Day 60
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16 participants
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Number of Participants Who Showed Improvement With the Starch Iodine Test at Days 30 and 90 Post Second Treatment
Day 120
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20 participants
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Adverse Events
Ultherapy Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ultherapy Treatment
n=20 participants at risk
Participants received two dual-depth Ultherapy treatment to each axilla at a treatment depth of 3.0 mm using 7-MHz transducer with 0.30 J of energy on Days 0 (Treatment 1) and 30 (Treatment 2). Participants were administered treatment in 3 inch\*4 inch grid, in at least 12 treatment squares. At each treatment visit, participants received a minimum of 720 treatment lines to each axilla (minimum of 1440 total lines of treatment for both axillae), delivering 60 treatment lines per treatment square.
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Nervous system disorders
Headache
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10.0%
2/20 • Baseline up to Day 120
The investigator asked the participant for adverse events (AEs) systematically at each visit.
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Nervous system disorders
Tingling
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40.0%
8/20 • Baseline up to Day 120
The investigator asked the participant for adverse events (AEs) systematically at each visit.
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General disorders
Hematoma
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80.0%
16/20 • Baseline up to Day 120
The investigator asked the participant for adverse events (AEs) systematically at each visit.
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General disorders
Tenderness
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15.0%
3/20 • Baseline up to Day 120
The investigator asked the participant for adverse events (AEs) systematically at each visit.
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Respiratory, thoracic and mediastinal disorders
Bronchitis
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10.0%
2/20 • Baseline up to Day 120
The investigator asked the participant for adverse events (AEs) systematically at each visit.
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Gastrointestinal disorders
Gastritis
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5.0%
1/20 • Baseline up to Day 120
The investigator asked the participant for adverse events (AEs) systematically at each visit.
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Gastrointestinal disorders
Nausea
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5.0%
1/20 • Baseline up to Day 120
The investigator asked the participant for adverse events (AEs) systematically at each visit.
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Nervous system disorders
Neuritis
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5.0%
1/20 • Baseline up to Day 120
The investigator asked the participant for adverse events (AEs) systematically at each visit.
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General disorders
Swelling
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5.0%
1/20 • Baseline up to Day 120
The investigator asked the participant for adverse events (AEs) systematically at each visit.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
- Publication restrictions are in place
Restriction type: OTHER