Evaluation of the Ulthera System for Treating Axillary Hyperhidrosis

NCT03320096 | Completed Results FDA Device

• 2 other identifiers: M960001007DRKS00011603
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Axillary Hyperhidrosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Reduction at Day 30 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).

  Day 60 (30 days post second treatment)

Secondary Outcomes (3)

• Number of Participants With HDSS Score Reduction at Day 90 Post Second Treatment

  Day 120 (90 days post second treatment)

• Number of Participants With Gravimetric Axillary Sweat Reduction by at Least 50 Percent (%) at Days 30 and 90 Post Second Treatment

  Days 60 (30 days post second treatment) and 120 (90 days post second treatment)

• Number of Participants Who Showed Improvement With the Starch Iodine Test at Days 30 and 90 Post Second Treatment

  Days 60 (30 days post second treatment) and 120 (90 days post second treatment)

Study Arms (1)

Microfocused ultrasound with visualization

EXPERIMENTAL

Device: Microfocused ultrasound with visualization

Interventions

Microfocused ultrasound with visualization DEVICE

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.)

Also known as: Ultherapy, Ulthera treatment

Microfocused ultrasound with visualization

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (2)

Rosenpark Research, Study Research Center; Merz Investigational Site #0490099

Darmstadt, 64283, Germany

Location

Haut- & Laserzentrum, Merz Investigational Site #0490362

Potsdam, 14467, Germany

Location

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Pharmaceuticals GmbH

clinicaltrials@merz.com

+49 69 1503 1

Study Officials

• Merz Medical Expert

  Merz North America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: October 25, 2017
• Study Start: December 13, 2016
• Primary Completion: June 19, 2017
• Study Completion: August 22, 2017
• Last Updated: July 10, 2019
• Results First Posted: July 10, 2019

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)