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Trial record 23 of 174 for:    "Sweat Gland Disease"

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 )

Brief Summary:
To evaluate the Ulthera System and the 7-3.0mm transducer for treating axillary hyperhidrosis.

Condition or disease Intervention/treatment Phase
Axillary Hyperhidrosis Device: Microfocused ultrasound with visualization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Ulthera System for Treating Axillary Hyperhidrosis
Actual Study Start Date : December 13, 2016
Actual Primary Completion Date : June 19, 2017
Actual Study Completion Date : August 22, 2017

Arm Intervention/treatment
Experimental: Microfocused ultrasound with visualization 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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320096


Locations
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Germany
Rosenpark Research, Study Research Center; Merz Investigational Site #0490099
Darmstadt, Germany, 64283
Haut- & Laserzentrum, Merz Investigational Site #0490362
Potsdam, Germany, 14467
Sponsors and Collaborators
Ulthera, Inc
Investigators
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Study Director: Merz Medical Expert Merz North America, Inc.
  Study Documents (Full-Text)

Documents provided by Merz North America, Inc. ( Ulthera, Inc ):

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Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT03320096     History of Changes
Other Study ID Numbers: M960001007
DRKS00011603 ( Registry Identifier: DRKS )
First Posted: October 25, 2017    Key Record Dates
Results First Posted: July 10, 2019
Last Update Posted: July 10, 2019
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases