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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 )

Tracking Information
First Submitted Date  ICMJE October 20, 2017
First Posted Date  ICMJE October 25, 2017
Results First Submitted Date  ICMJE June 14, 2019
Results First Posted Date  ICMJE July 10, 2019
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE December 13, 2016
Actual Primary Completion Date June 19, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
Number of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Reduction at Day 30 Post Second Treatment [ Time Frame: Day 60 (30 days 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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 20, 2017)
Hyperhidrosis Disease Severity Scale (HDSS) score reduction at day 30 post second treatment [ Time Frame: 60 days from Baseline (= 30 days post second treatment) ]
HDSS score reduction from a 3 or 4 at baseline to a 1 or 2 at 30 days post second treatment. The HDSS is a validated 4-point scale providing qualitative measures of the severity of patient condition based on how it affects their lives ranging from 1(my underarm sweating is never noticeable and never interferes with my daily activities ) to 4 (my underarm sweating is intolerable and always interferes with my daily activities).
Change History Complete list of historical versions of study NCT03320096 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Number of Participants With HDSS Score Reduction at Day 90 Post Second Treatment [ Time Frame: Day 120 (90 days 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).
  • Number of Participants With Gravimetric Axillary Sweat Reduction by at Least 50 Percent (%) at Days 30 and 90 Post Second Treatment [ Time Frame: Days 60 (30 days post second treatment) and 120 (90 days 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.
  • Number of Participants Who Showed Improvement With the Starch Iodine Test at Days 30 and 90 Post Second Treatment [ Time Frame: Days 60 (30 days post second treatment) and 120 (90 days 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2017)
  • Reduction in spontaneous axillary sweat production assessed by gravimetric method at all time points following completion of study treatment(s), as measured by a 50% reduction or more compared to baseline [ Time Frame: Baseline to day 60 (=30 days post 2nd treatment) and day 120 (=90 days post 2nd treatment) ]
    Gravimetric method is performed by drying the surface of the skin, then applying a pre-weighed filter paper to the axilla for a period of time measured by a stopwatch. The paper is then weighed and the rate of sweat production is calculated in mg/min.
  • Hyperhidrosis Disease Severity Scale (HDSS) score reduction 90 days post treatment #2. [ Time Frame: Baseline to day 120 (=90 days post second treatment) ]
    HDSS score reduction from a 3 or 4 at baseline to a 1 or 2 at 90 days post second treatment.
  • Starch iodine test to assess area of efficacy [ Time Frame: 120 days from Baseline (= 90 days post second treatment) ]
    Starch Iodine test is performed by applying an iodine solution to the sweaty area. After it dries, starch is sprinkled on the area. The starch-iodine combination turns a dark blue color wherever excess sweat is present. Digital images of the starch iodine test will be obtained.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Ulthera System for Treating Axillary Hyperhidrosis
Official Title  ICMJE Evaluation of the Ulthera System for Treating Axillary Hyperhidrosis
Brief Summary To evaluate the Ulthera System and the 7-3.0mm transducer for treating axillary hyperhidrosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Axillary Hyperhidrosis
Intervention  ICMJE Device: Microfocused ultrasound with visualization
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.)
Other Names:
  • Ultherapy
  • Ulthera treatment
Study Arms  ICMJE Experimental: Microfocused ultrasound with visualization
Intervention: Device: Microfocused ultrasound with visualization
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2017)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 22, 2017
Actual Primary Completion Date June 19, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, age 18-75 years.
  • 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. An attempt will be made to approximate an equal number of scores 3 and 4.
  • Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other NSAID, and Vitamin E in the 2 weeks prior to each study treatment .

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, iodine, lidocaine, or epinephrine.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03320096
Other Study ID Numbers  ICMJE M960001007
DRKS00011603 ( Registry Identifier: DRKS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Merz North America, Inc. ( Ulthera, Inc )
Study Sponsor  ICMJE Ulthera, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Merz Medical Expert Merz North America, Inc.
PRS Account Merz North America, Inc.
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP