Primary axillary hyperhidrosis MedDRA version: 19.1 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-
Sponsors
Dermira, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80% treatment compliance. 2. Signed informed consent. 3. Willing to comply with the protocol. 4. Male or non-pregnant (negative urine pregnancy test in female subjects of child-bearing potential), nonlactating females. 5. If female and of childbearing potential, subject must use an accepted method of birth control during study participation and for 30 days after the last study drug application. Females are considered to be of childbearing potential unless surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation), have been diagnosed as infertile, have same gender sex partner, are postmenopausal for at least 1 year. Acceptable methods of birth control include: abstinence, oral contraceptives, contraceptive patches/implants; injectable contaceptives. Birth control method must have been stable/unchanged for 12 weeks prior to Baseline and must remain unchanged during study participation. 6. If male, is vasectomized or agrees to use an accepted method of birth control with female partner during study participation and for 30 days after the last study drug application. Male subjects must agree not to donate sperm. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Subject has a clinically significant abnormality on physical exam, vital signs or ECG at the week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further treatment with DRM04 contraindicated, as determined by the Investigator. 2. Male with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy. 3. Any other condition which, in the judgment of the Investigator, would put the subject at unacceptable risk for participation in the study. 4. 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. 5. Subjects who are institutionalized because of legal or regulatory order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to assess the long-term safety of DRM04 Topical Wipes, 3.75% in subjects with primary axillary hyperhidrosis in a minimum of 100 subjects for at least 12 months.;Secondary Objective: Not applicable;Primary end point(s): Primary Endpoint: No inferential statistics are planned for this study.;Timepoint(s) of evaluation of this end point: Not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Germany, United States
Contacts
Public ContactSenior Director, Clinical Operation
Dermira, Inc.
Outcome results
None listed