Histological Analysis Following Ulthera System Treatment for Hyperhidrosis

NCT01708551 | Completed

• 1 other identifier: ULT-134
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Up to 60 subjects will be enrolled into one of five treatment groups. Subjects enrolled in Groups A, B or C will undergo axillary punch biopsies during the course of the trial to determine the number and depth of the sweat glands, and receive dual depth treatments (4.5mm and 3.0mm); either two bilateral Ultherapy™ treatments to the axillas 30 days apart (Groups A and B) or one bilateral Ultherapy™ treatment (Group C). Subjects in Groups D and E will receive two bilateral Ultherapy™ treatments to the axillas 30 days apart at a 2.0mm treatment depth and two different energy settings (Group D at 0.45 J, Group E at 0.30 J). Protocol amended (Sept 2014): Subjects in Groups D and E will receive treatments at the same energy setting (0.30J) and two treatment densities: Group D, 60 lines/treatment square; Group E, 40 lines per treatment square. Follow-up visits will occur at 7, 30, 90 and 180 days post-treatment #2.

Conditions

Hyperhidrosis

Keywords

Hyperhidrosis; Axillary sweating; Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.

Outcome Measures

Primary Outcomes (1)

• Reduction in the number of sweat glands from baseline to 90-days post-treatment.

  Based on histological analyses of biopsied, Ultherapy™-treated, tissue, the changed in the number of sweat glands present at 90days post-treatment will be compared to the number of sweat glands present at baseline.

  90 days post-treatment

Secondary Outcomes (6)

• Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment

  7 days post-treatment

• Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment

  30 days post-treatment

• Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment

  90 days post-treatment

• Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment

  180 days post-treatment

• HDSS score reduction

  90 days post-treatment

Study Arms (5)

Group A

ACTIVE COMPARATOR

Subjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments; dual depth treatment at 4.5mm and 3.0mm.

Device: Ulthera System Treatment

Group B

ACTIVE COMPARATOR

Subjects who were non-responders to a prior Ultherapy™ treatment for hyperhidrosis will receive bilateral Ulthera System treatments; dual depth treatment at 4.5mm and 3.0mm.

Device: Ulthera System Treatment

Group C

ACTIVE COMPARATOR

Subjects will receive one double-density Ulthera System treatment; dual depth treatment at 4.5mm and 3.0mm.

Device: Ulthera System Treatment

Group D

ACTIVE COMPARATOR

Subjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments at 2.0mm treatment depth and standard energy level.

Device: Ulthera System Treatment

Group E

ACTIVE COMPARATOR

Subjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments at 2.0mm treatment depth and adjusted energy level.

Device: Ulthera System Treatment

Interventions

Ulthera System Treatment DEVICE

Focused ultrasound energy delivered below the surface of the skin

Also known as: Ultherapy™

Group A; Group B; Group C; Group D; Group E

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 and female, ages 18-75
• Subject is in good health
• Diagnosis of bilateral axillary hyperhidrosis refractory to previous topical therapies
• Groups A, C, D and E: 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.) Group B: A mean of \>50mg/5min of sweat production following a prior Ultherapy treatment.
• A HDSS score is 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.
• Absence of physical conditions unacceptable to the investigator.
• Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
• Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control.

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
• 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.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (1)

The Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mark Nestor, MD, PhD

  The Center for Clinical and Cosmetic Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON 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 17, 2012
• Study Start: August 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 14, 2017

Record last verified: 2015-10

Locations

US (1)