Hyperhidrosis Clinical Trial
Official title:
Feasibility Study: Evaluation of the Safety and Efficacy of the Ulthera® System for the Treatment of Axillary Hyperhidrosis
Verified date | June 2013 |
Source | Merz Pharmaceuticals, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | June 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | The Center for Clinical & Cosmetic Research | Aventura | Florida |
Lead Sponsor | Collaborator |
---|---|
Ulthera, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in sweat production | Axillary hyperhidrosis as assessed by using a gravimetric method. | 90-days post-treatment treatment #2 | |
Secondary | Improvement in sweat production at follow-up timepoints other than 90 days post-treatment | Axillary hyperhidrosis as assessed by using a gravimetric method. | Participants will be followed up to 60 days post-treatment | |
Secondary | Area of efficacy | Starch iodine test will be used to assess the area of efficacy. Imaging will be obtained. | Participants will be followed for up to 90 days following treatment #2. | |
Secondary | Qualitative measure of hyperhidrosis severity | 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. | Participants will be followed for up to 90 days following treatment #2 |
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