Primary axillary hyperhidrosis MedDRA version: 18.1 Level: PT Classification code 10020642 Term: Hyperhidrosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Glycopyrronium tosylate
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 3.75 -
Pharmaceutical form of the placebo: Cutaneous solution
Route of adminis
Sponsors
Dermira, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent. 2. Age =18 years. 3. Willing to comply with the protocol. 4. Male or non-pregnant (negative urine pregnancy test in female subjects of child-bearing potential), non-lactating females. 5. Primary, axillary hyperhidrosis of at least 6 months duration. 6. HDSS of 3 or 4 at Baseline. 7. Average ASDD item #2 score of =4 at Baseline. Subjects must at a minimum complete 4-7 days of the ASDD within 7 days of randomization. 8. Sweat production of at least 50 mg over 5 minutes in each axilla assessed gravimetrically. Subjects with a measurement of =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Current pregnancy or lactation. 2. Prior surgical procedure for hyperhidrosis. 3. Prior axillary treatment with an anti-hyperhidrosis medical device (approved or investigational), such as miraDry®. 4. Prior treatment with axillary iontophoresis within 4 weeks of Baseline. 5. Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1. 6. Subject who are actively participating in an experimental therapy study or who received experimental therapy within 30 days or 5 half-lives (whichever is longer) of the Baseline Visit. 7. Previous active treatment in the Dermira DRM04-HH01 or DRM04-HH02 clinical trials. 8. Axillary use of nonprescription antiperspirants within 1 week or prescription antiperspirants within 2 weeks of Baseline. 9. Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator. 10. Abnormal findings on screening ECG deemed clinically significant by the Investigator. 11. Treatment with psychotherapeutic medications (including benzodiazepines or selective serotonin reuptake inhibitors [SSRIs]). Subjects on new or regimens of psychotherapeutic medications that have changed within 2 months of baseline. 12. Treatment with medications having systemic anticholinergic activity, centrally acting alpha-2 adrenergic agonists (e.g. clonidine, guanabenz, methyl dopa), or beta-blockers within 4 weeks of the baseline visit unless dosing has been stable for at least 4 months prior to Baseline and is not expected to change over the course of the study (inhaled anti-cholinergic drugs or beta agonists are allowed). 13. Intravenous (IV), oral glycopyrrolate treatment or any treatment with atropine, belladonna, scopolamine, clindinium or hyoscyamine within 4 weeks prior to Baseline. 14. Secondary axillary hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis (e.g., lymphoma, malaria, severe anxiety not controlled by medication, carcinoid syndrome, substance abuse, hyperthyroidism). 15. Known history of Sjögren’s syndrome or Sicca syndrome. 16. History of glaucoma, inflammatory bowel disease, toxic megacolon, or febrile illness. 17. Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy. 18. History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter. History of other supraventricular tachycardia with a ventricular rate greater than 100 (other than sinus tachycardia). 19. Subjects who are a poor medical risk because of 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. 20. Close affiliation with the investigator (e.g. a close relative) or persons working at the trial sites or subject who is an employee of the Sponsor’s company. 21. Subjects who are institutionalized because of legal or regulatory order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study will be to assess the efficacy and safety of DRM04 Topical Wipes, 3.75% compared to vehicle when applied once daily for 28 days in subjects with primary axillary hyperhidrosis.;Secondary Objective: Not applicable;Primary end point(s): - Mean absolute change from baseline in gravimetrically-measured sweat production at Week 4. - Proportion of subjects who have a =4-point improvement in the weekly mean score of ASDD item #2 from baseline at Week 4.;Timepoint(s) of evaluation of this end point: Will both be measured at week 4 in comparisation to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of subjects who have a =2 grade improvement in HDSS from baseline at Week 4 - Proportion of subjects who have at least a 50% reduction in gravimetrically measured sweat production from baseline at Week 4.;Timepoint(s) of evaluation of this end point: Will both be measured at week 4 in comparisation to baseline. | — |
Countries
Germany, United States
Contacts
Public ContactSenior Director, Clinical Operation
Dermira, Inc.
Outcome results
None listed