Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT01708551
Eligibility Criteria:
Inclusion Criteria:
* 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.
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.
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01708551
Study Brief:
Protocol Section:
NCT01708551