Ulthera® System for Treating Axillary Hyperhidrosis

NCT02286765 | Completed

• 1 other identifier: ULT-126
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Up to 20 enrolled subjects will be treated. Subjects will receive two Ulthera® treatments on the axillas provided 30 days apart. Follow-up visits will occur at 7, 30, 90 and 180 days following the last treatment. Protocol amendment: The study was expanded to enroll an additional 20 subjects into Group A.

Conditions

Primary Axillary Hyperhidrosis

Keywords

Ulthera System; Ultherapy

Outcome Measures

Primary Outcomes (1)

• HDSS score reduction

  HDSS score reduction from a 3 or 4 at baseline to a 1 or 2 at 30 days post-treatment #2.

  Day 30 post-treatment #2

Secondary Outcomes (8)

• Sweat production by gravimetric measure

  7 Days post-treatment #2

• Sweat production by gravimetric measure

  90 Days post-treatment #2

• Sweat production by gravimetric measure

  30 Days post-treatment #2

• Sweat production by gravimetric measure

  180 Days post-treatment #2

• HDSS score reduction

  90 Days post-treatment #2

Study Arms (2)

Group A

ACTIVE COMPARATOR

Subjects receiving Ulthera System treatment in a 3 x 4 grid, 12 treatment squares, 60 lines of treatment per square, at one treatment depth (2.0mm), at 0.30 J of energy

Device: Ulthera System treatment

Group B

ACTIVE COMPARATOR

Subjects receiving Ulthera System treatment in a 3 x 4 grid, 12 treatment squares, 40 lines of treatment per square, at one treatment depth (2.0mm), at 0.30 J of energy

Device: Ulthera System treatment

Interventions

Ulthera System treatment DEVICE

Micro-focused ultrasound energy delivered below the surface of the skin

Also known as: Ultherapy

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18-75 years.
• Subject in good health.
• 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.
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
• Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
• Postmenopausal for at least 12 months prior to study;
• Without a uterus and/or both ovaries; or
• Bilateral tubal ligation at least six months prior to study enrollment.
• Absence of physical or psychological conditions unacceptable to the investigator.
• 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 .
• Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.

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.
• Unwillingness to wash off deodorants and abstain use 72 hours prior to treatments or assessments.
• Subjects with a history of a bleeding disorder
• Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas.)
• Use of cholinomimetics, anticholinergics, or any oral herbal medicine treatments for hyperhidrosis.
• Inability to withhold use of antiperspirants and deodorants, or any other topical treatments for hyperhidrosis within 72 hours prior to study treatments and assessments.
• Unwillingness for complete shaving or removal of underarm hair within 12 hours prior to study treatments and follow-up visits.
• Women who are pregnant, lactating, possibly pregnant or planning a pregnancy during the study period.
• Inability to understand the protocol or to give informed consent.
• History of chronic drug or alcohol abuse.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (1)

Saint Louis University Dermatology

St Louis, Missouri, 63104, United States

Location

Study Officials

• Kari Larson, MBA

  Ulthera, Inc

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 10, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)