NCT01713959

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
Last Updated

November 24, 2017

Status Verified

June 1, 2013

Enrollment Period

8 months

First QC Date

October 15, 2012

Last Update Submit

November 21, 2017

Conditions

Hyperhidrosis

Keywords

Underarm sweating

Outcome Measures

Primary Outcomes (1)

  • Improvement in sweat production

    Axillary hyperhidrosis as assessed by using a gravimetric method.

    90-days post-treatment treatment #2

Secondary Outcomes (3)

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

    Participants will be followed up to 60 days post-treatment

  • Area of efficacy

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

  • Qualitative measure of hyperhidrosis severity

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

Study Arms (2)

Group A - Split Body Treatment

EXPERIMENTAL

Active treatment of one axilla with the Ulthera System Treatment; Sham treatment of one axilla.

Device: Ulthera System treatmentDevice: Sham treatment

Group B: Ulthera System Treatment w lido

ACTIVE COMPARATOR

Subjects receive a bilateral Ulthera System Treatment, with one axilla receiving a subcutaneous lidocaine injection.

Device: Ulthera System treatment

Interventions

Ulthera System treatmentDEVICE

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

Also known as: Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
Group A - Split Body TreatmentGroup B: Ulthera System Treatment w lido
Sham treatmentDEVICE

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

Group A - Split Body Treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Clinical & Cosmetic Research

Aventura, Florida, 33180, United States

Location

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

Sweat Gland DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Mark Nestor, MD, Ph.D

    The Center for Clinical & Cosmetic Research

    PRINCIPAL INVESTIGATOR

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

October 15, 2012

First Posted

October 25, 2012

Study Start

August 1, 2011

Primary Completion

April 1, 2012

Study Completion

June 1, 2012

Last Updated

November 24, 2017

Record last verified: 2013-06

Locations

US(1)