The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

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
Allocation:	N/A
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 :

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 :

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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

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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

Ulthera, Inc

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Study Director:	Merz Medical Expert	Merz North America, Inc.

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

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Responsible Party:	Ulthera, Inc
ClinicalTrials.gov Identifier:	NCT03320096
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
Product Manufactured in and Exported from the U.S.:	Yes

Additional relevant MeSH terms:

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Hyperhidrosis Sweat Gland Diseases Skin Diseases

||||I|||| We're building a better ClinicalTrials.gov. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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Please remove one or more studies before adding more. Evaluation of the Ulthera System for Treating Axillary Hyperhidrosis (ULT-218) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. ClinicalTrials.gov Identifier: NCT03320096 Recruitment Status : Completed First Posted : October 25, 2017 Results First Posted : July 10, 2019 Last Update Posted : July 10, 2019 View this study on Beta.ClinicalTrials.gov Sponsor: Ulthera, Inc Information provided by (Responsible Party): Merz North America, Inc. ( Ulthera, Inc ) * Study Details * Tabular View * Study Results * Disclaimer * How to Read a Study Record Study Description Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information 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 Study Design Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 20 participants Allocation: N/A 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 Arms and Interventions Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Arm Intervention/treatment 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.) Experimental: Microfocused ultrasound with visualization Other Names: * Ultherapy * Ulthera treatment Outcome Measures Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information 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. Eligibility Criteria Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Layout table for eligibility information 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. Contacts and Locations Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information 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 Layout table for location information 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 Layout table for investigator information Study Director: Merz Medical Expert Merz North America, Inc. Study Documents (Full-Text) Documents provided by Merz North America, Inc. ( Ulthera, Inc ): Study Protocol and Statistical Analysis Plan [PDF] September 7, 2016 More Information Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Layout table for additonal information Responsible Party: Ulthera, Inc ClinicalTrials.gov Identifier: NCT03320096 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 Layout table for additional information Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: Yes Product Manufactured in and Exported from the U.S.: Yes Additional relevant MeSH terms: Layout table for MeSH terms Hyperhidrosis Sweat Gland Diseases Skin Diseases To Top * For Patients and Families * For Researchers * For Study Record Managers * Home * RSS Feeds * Site Map * Terms and Conditions * Disclaimer * Customer Support * Copyright * Privacy * Accessibility * Viewers and Players * Freedom of Information Act * USA.gov * HHS Vulnerability Disclosure * U.S. National Library of Medicine * U.S. National Institutes of Health * U.S. Department of Health and Human Services

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