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:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT02530294
Eligibility Criteria:
Inclusion Criteria:
* Male or female ≥ 9 years of age.
* Primary, axillary hyperhidrosis of at least 6 months duration.
* Hyperhidrosis Disease Severity Scale (HDSS) of 3 or 4 at Baseline.
* Axillary Sweating Daily Diary (ASDD) ≥ 4 at Baseline.
* Sweat production of at least 50 mg over 5 minutes in each axilla assessed gravimetrically.
Exclusion Criteria:
* Prior surgical procedure for hyperhidrosis.
* Prior axillary treatment with an anti-hyperhidrosis medical device (approved or investigational).
* Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1.
* Previous active treatment in the Dermira DRM04-HH01 or DRM04-HH02 clinical trials.
* Axillary use of nonprescription antiperspirants within 1 week or prescription antiperspirants within 2 weeks of Baseline.
* Subjects on new or regimens of psychotherapeutic medications that have changed within 2 months of baseline.
* Treatment with systemic anticholinergics within 4 weeks of the baseline visit unless dosing has been stable for at least 4 months.
* Other treatment with glycopyrrolate within 4 weeks prior to Baseline.
* Secondary axillary hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis.
* History of Sjögren's syndrome or Sicca syndrome.
* History of glaucoma, inflammatory bowel disease, toxic megacolon, or febrile illness.
* Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.
* History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter.
* Other systemic diseases or active uncontrolled infections, or any other condition which, in the judgment of the Investigator, would put the subject at unacceptable risk for participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
9 Years
Study:
NCT02530294
Study Brief:
Protocol Section:
NCT02530294