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Completed

NCT Number: NCT01713959

Feasibility Study: Ulthera® System for the Treatment of Axillary Hyperhidrosis

Single-center, randomized, split-body, pilot study, treatment of up to 23 subjects in two treatment groups. Subjects will receive two Ultherapy treatments at Day 0 with follow-ups at 7 and 14 days post-treatment #1, and Day 28 with follow-ups are 7, 14, 30, 60, 90 days post-treatment #2.

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Key information

Conditions

Hyperhidrosis Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Center for Clinical & Cosmetic Research

Aventura, Florida, 33180, United States

About this study

Subjects will be randomized to one of two study groups:

  • Group A: Split body treatment. Ultherapy to one axilla, Sham treatment to the other axilla.
  • Group B: Bilateral Ultherapy treatments, with a pre-treatment subcutaneous lidocaine injection administered to one axillary side.

Hyperhidrosis Disease Severity Scale (HDSS), gravimetric test and starch iodine test will be obtained at all study visits. Patient satisfaction questionnaires will also be obtained at 30, 60 and 90 days post-treatment #2.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female, ages 18-75
  • Subject is 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.
  • Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.

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 or iodine.
  • 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.
  • Women who are pregnant, lactating, possibly pregnant or planning a pregnancy during the study period.

Treatment and study plan

Ulthera System Treatment

Device

Ulthera System: Focused ultrasound energy delivered below the surface of the skin.

Other names: Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening

Sham treatment

Device

Sham Treatment: Use of the Ulthera System with the system adjusted to deliver 0 energy.

Primary outcomes

  1. Improvement in sweat production

    Time frame: 90-days post-treatment treatment #2

    Axillary hyperhidrosis as assessed by using a gravimetric method.

Secondary outcomes

  1. Improvement in sweat production at follow-up timepoints other than 90 days post-treatment

    Time frame: Participants will be followed up to 60 days post-treatment

    Axillary hyperhidrosis as assessed by using a gravimetric method.

  2. Area of efficacy

    Time frame: Participants will be followed for up to 90 days following treatment #2.

    Starch iodine test will be used to assess the area of efficacy. Imaging will be obtained.

  3. Qualitative measure of hyperhidrosis severity

    Time frame: Participants will be followed for up to 90 days following treatment #2

    The HDSS is a scale used for primary axillary/underarm hyperhidrosis patients. It provides a qualitative measure of the severity of their condition based on how it affects their daily activities. Patients select the statement that best reflects their experience with underarm sweating.

Sponsors and collaborators

Lead sponsor

Ulthera, Inc

Industry

Registry information

Official study title

Feasibility Study: Evaluation of the Safety and Efficacy of the Ulthera® System for the Treatment of Axillary Hyperhidrosis

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 25, 2012
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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