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Evaluation of the Ulthera System for Treating Axillary Hyperhidrosis (ULT-218)

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ClinicalTrials.gov Identifier: NCT03320096
Recruitment Status : Completed
First Posted : October 25, 2017
Results First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc. ( Ulthera, Inc )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Axillary Hyperhidrosis
Intervention Device: Microfocused ultrasound with visualization
Enrollment 20
Recruitment Details The study was conducted at 2 sites in Germany.
Pre-assignment Details A total of 20 participants were screened, enrolled and treated in the study.
Arm/Group Title Ultherapy Treatment
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title Ultherapy Treatment
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
Full analysis set (FAS) was the subset of participants in the safety evaluation set (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). SES was the subset of all participants who were exposed to study treatment at least once.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
40.3  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
16
  80.0%
Male
4
  20.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
20
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
20
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 20 participants
20
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 20 participants
24.1  (4.0)
Fitzpatrick Skin Type   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Skin Type I
0
   0.0%
Skin Type II
15
  75.0%
Skin Type III
4
  20.0%
Skin Type IV
1
   5.0%
Skin Type V
0
   0.0%
Skin Type VI
0
   0.0%
[1]
Measure Description: Skin type I = white; very fair, red or blonde hair blue eyes; freckles; always burns, never tans, skin type II = white, fair, red or blond hair; blue, hazel or green eyes; usually burns, tans with difficulty, skin type III = cream white; fair with any eye or hair color (common); sometimes mild burn, gradually tans, skin type IV = brown; typical Mediterranean Caucasian skin; rarely burns, tans with ease, skin type V = dark brown; mid-eastern skin types; very rarely burns, tans easily, and skin type VI = black; never burns, tans very easily.
1.Primary Outcome
Title Number of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Reduction at Day 30 Post Second Treatment
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ultherapy Treatment
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
11
2.Secondary Outcome
Title Number of Participants With HDSS Score Reduction at Day 90 Post Second Treatment
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ultherapy Treatment
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
15
3.Secondary Outcome
Title Number of Participants With Gravimetric Axillary Sweat Reduction by at Least 50 Percent (%) at Days 30 and 90 Post Second Treatment
Hide Description 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.
Time Frame Days 60 (30 days post second treatment) and 120 (90 days post second treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ultherapy Treatment
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
Day 60 12
Day 120 15
4.Secondary Outcome
Title Number of Participants Who Showed Improvement With the Starch Iodine Test at Days 30 and 90 Post Second Treatment
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ultherapy Treatment
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
Day 60 16
Day 120 20
Time Frame Baseline up to Day 120
Adverse Event Reporting Description The investigator asked the participant for adverse events (AEs) systematically at each visit.
 
Arm/Group Title Ultherapy Treatment
Hide Arm/Group Description 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.
All-Cause Mortality
Ultherapy Treatment
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ultherapy Treatment
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ultherapy Treatment
Affected / at Risk (%)
Total   18/20 (90.00%) 
Gastrointestinal disorders   
Gastritis   1/20 (5.00%) 
Nausea   1/20 (5.00%) 
General disorders   
Hematoma   16/20 (80.00%) 
Tenderness   3/20 (15.00%) 
Swelling   1/20 (5.00%) 
Nervous system disorders   
Headache   2/20 (10.00%) 
Tingling   8/20 (40.00%) 
Neuritis   1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Bronchitis   2/20 (10.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Public Disclosure Manager
Organization: Merz Pharmaceuticals GmbH
Phone: +49 69 1503 1
EMail: clinicaltrials@merz.com
Layout table for additonal information
Responsible Party: Merz North America, Inc. ( Ulthera, Inc )
ClinicalTrials.gov Identifier: NCT03320096     History of Changes
Other Study ID Numbers: M960001007
DRKS00011603 ( Registry Identifier: DRKS )
First Submitted: October 20, 2017
First Posted: October 25, 2017
Results First Submitted: June 14, 2019
Results First Posted: July 10, 2019
Last Update Posted: July 10, 2019