N/A
Completed N=20
Evaluation of the Ulthera System for Treating Axillary Hyperhidrosis
Source: ClinicalTrials.gov NCT03320096 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Number of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Reduction at Day 30 Post Second Treatment — 11 participants
Summary
To evaluate the Ulthera System and the 7-3.0mm transducer for treating axillary hyperhidrosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Reduction at Day 30 Post Second Treatment |
11 | — |
| SECONDARY Number of Participants With HDSS Score Reduction at Day 90 Post Second Treatment |
15 | — |
| SECONDARY Number of Participants With Gravimetric Axillary Sweat Reduction by at Least 50 Percent (%) at Days 30 and 90 Post Second Treatment |
12; 15 | — |
| SECONDARY Number of Participants Who Showed Improvement With the Starch Iodine Test at Days 30 and 90 Post Second Treatment |
16; 20 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, age 18-75 years.
- 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. An attempt will be made to approximate an equal number of scores 3 and 4.
- Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other NSAID, and Vitamin E in the 2 weeks prior to each study treatment .
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, 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.
Data sourced from ClinicalTrials.gov (NCT03320096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.