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

Ulthera

Status

Completed

Conditions

Hyperhidrosis

Treatments

Drug: Sham treatment

Drug: Ulthera System Treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT01713673

ULT-125

Details and patient eligibility

About

Up to 20 subjects will be treated. Subjects will receive two (2) bilateral Ultherapy™ or Sham treatments of the axilla. The study hypothesis is that subjects who receive Ultherapy™ treatment will have a greater reduction in axillary sweating compared to subjects receiving Sham treatments. Follow-up visits will occur at 7 and 14 days following treatment #1, and at 7, 14, 30, 60 and 90 days following treatment #2. At each follow-up visit, assessments will be completed to compare the amount of axillary sweating compared to baseline.

Full description

This study is a prospective, single-center, randomized, sham-controlled, blinded pilot clinical trial. Subjects will be randomly assigned to one of two treatment groups in a 2:1 randomization scheme, two (2) subjects assigned to receive Ultherapy™ treatment to every one subject assigned to receive Sham treatment.

Gravimetric measurement of sweat production and starch iodine tests will be performed, and Hyperhidrosis Disease Severity Scale (HDSS) scores will be obtained, prior to treatment and at each follow-up visit. Patient satisfaction will also be assessed. Sham treated subjects will have the option of continuing to Stage II and receive active treatment after completion of their Stage I 90 day study visit.

In a protocol amendment, the initial Stage I study cohort, excluding Sham treated subjects who opt to continue to Stage II, will be recruited to complete one long-term follow-up visit at 365 days following subjects' second study treatment. The same follow-up assessments will be completed to compare the amount of axillary sweating compared to baseline.

Enrollment

20 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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 over a period of 5 minutes
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

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
Unwillingness to wash off deodorants and abstain use 72 hours prior to treatments or assessments
History of previous Ultherapy™ treatment to the axilla
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