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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01713673
• Date of registration: 22/10/2012
• Prospective Registration: No
• Primary sponsor: Ulthera, Inc
• Public title: Feasibility Study: Safety and Efficacy of the Ulthera® System for Treatment of Axillary Hyperhidrosis
• Scientific title: Feasibility Study: A Prospective, Parallel, Randomized, Sham-controlled, Blinded Pilot Trial of the Safety and Efficacy of the Ulthera® System for Treatment of Axillary Hyperhidrosis
• Date of first enrolment: December 2011
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01713673
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Mark Nestor, MD, PhD
• Affiliation: The Center for Clinical and Cosmetic Research

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hyperhidrosis

Intervention(s)

Drug: Ulthera System Treatment

Drug: Sham treatment

Primary Outcome(s)

Percentage of subjects with HDSS scores of 1 or 2 [Time Frame: 30 days post-treatment #2]

Secondary Outcome(s)

Reduction in spontaneous axillary sweat production [Time Frame: Participants will be followed to 365 days post treatment #2]

Subject Satisfaction [Time Frame: Participants will be followed to 365 days post-treatment #2]

Secondary ID(s)

ULT-125

Source(s) of Monetary Support

Please refer to primary and secondary sponsors