Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02530294 |
|
Recruitment Status :
Completed
First Posted : August 21, 2015
Results First Posted : August 14, 2018
Last Update Posted : September 25, 2018
|
Sponsor:
Dermira, Inc.
Information provided by (Responsible Party):
Dermira, Inc.
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
The study is a randomized, double-blind, vehicle controlled, parallel group study, designed to assess the efficacy and safety of glycopyrronium topical wipes, once daily, compared to vehicle in subjects with axillary hyperhidrosis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hyperhidrosis | Drug: glycopyrronium Topical Wipes Other: Vehicle | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 353 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis |
| Study Start Date : | August 2015 |
| Actual Primary Completion Date : | April 2016 |
| Actual Study Completion Date : | April 2016 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: glycopyrronium
glycopyrronium Topical Wipes
|
Drug: glycopyrronium Topical Wipes
Topical wipes containing glycopyrronium
Other Name: DRM04 |
|
Placebo Comparator: Vehicle
glycopyrronium Topical Wipes, Vehicle
|
Other: Vehicle
Vehicle (placebo) topical wipes |
Primary Outcome Measures :
- Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of Axillary Sweating Daily Diary (ASDD) Item #2 From Baseline at Week 4 [ Time Frame: From Baseline to Week 4 ]
The Axillary Sweating Daily Diary (ASDD) is a 4-item instrument designed to measure the severity of axillary hyperhidrosis and its impact on daily activities. The 4 Items are:
- During the past 24 hours, did you have any underarm sweating? (Yes or No)
- During the past 24 hours, how would you rate your underarm sweating at its worst? (0=No sweating at all, 1, 2,…, 10=Worst possible sweating)
- During the past 24 hours, to what extent did your underarm sweating impact your activities? (0=Not at all, 1=A little bit, 2=A moderate amount, 3=A great deal and 4=An extreme amount)
- During the past 24 hours, how bothered were you by your underarm sweating? (0=Not at all bothered, 1=A little bothered, 2=Moderately bothered, 3=Very bothered, 4=Extremely bothered)
- Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 [ Time Frame: Baseline - Week 4 ]Subjects are acclimated to the environment for 30 minutes. Dry gauze is weighed. The dry gauze is then applied to the subject's axilla with the arm down by the subject's side or on their lap during the 5-minute period of sweat production. The gauze with the sweat is then weighed. The difference between the Weight of the gauze with sweat and the dry gauze is the gravimetric sweat measurement in mg/5min.
- Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4 [ Time Frame: From Baseline to Week 4 ]
Secondary Outcome Measures :
- Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4 [ Time Frame: From Baseline to Week 4 ]Hyperhidrosis Disease Severity Scale (HDSS) is a disease specific diagnostic tool that provides a qualitative measure of the severity of the subjects' condition based on how it affects daily activities.
- Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4 [ Time Frame: From Baseline to Week 4 ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 9 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530294
Locations
Show 20 study locations
Sponsors and Collaborators
Dermira, Inc.
Investigators
| Study Director: | Lynne M Deans, MT | Dermira, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dermira, Inc. |
| ClinicalTrials.gov Identifier: | NCT02530294 |
| Other Study ID Numbers: |
DRM04-HH05 2015-002053-35 ( EudraCT Number ) |
| First Posted: | August 21, 2015 Key Record Dates |
| Results First Posted: | August 14, 2018 |
| Last Update Posted: | September 25, 2018 |
| Last Verified: | August 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Additional relevant MeSH terms:
|
Hyperhidrosis Sweat Gland Diseases Skin Diseases |